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1
Gandhi, Kunjan, Sunil Kumar Shah, C. K. Tyagi, Prabhakar Budholiya, and Harish Pandey. "Formulation, Development and Evaluation of Uncoated Bilayer Tablet of Anti-Hypertensive Agents." Journal of Drug Delivery and Therapeutics 10, no. 4-s (2020): 100–107. http://dx.doi.org/10.22270/jddt.v10i4-s.4229.
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The present research work was carried out to Formulate and evaluation of bilayer tablet dosage form for the treatment of Hypertension.The objective of this study to compare the specific characteristics of Metoprolol [beta selective (cardio selective) adrenoreceptor blocking agent] and Hydrochlorothiazide (Thiazide Diuretics]) in order to design stable formulation. It can be concluded that bilayer tablet were successfully formulated to achieve immediate release of Hydrochlorothiazide (HCTZ) and tailored release of Metoprolol (MPL)by using Dual Release Drug Absorption System(DUREDAS technology).Both drugs were found to be stable in Bilayer tablet formulation and were found to be stable for few months. This bilayer tablet dosage form increases the stability which may reduce loss and cost of formulation. It improves the benefits of producer, retailer, and patients. Recently, greater attention has been focused on development of bilayer tablet formulations. Over the past 30 years, the expenses and complications involved in marketing new drug entities have increased with concomitant recognition of therapeutic advantages of conventional drug delivery system. Several pharmaceutical companies are currently developing bi-layer tablets, for a variety of reasons: patent extension, efficient pharmacological effect, better patient compliance, etc. Bilayer tablet is becoming new approach for the successful drug delivery system and for better stability in combination. Bilayer tablets can be primary option to avoid chemical incompatibilities between APIs by physical separation.
 Keywords: Bilayer tablet, DUREDAS Technology, Antihypertensive, Metoprolol, Hydrochlorthiazide
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K, Kulkarni, and Deokar G. "From Challenges to Advancement for Bilayer Tablet Technology as Drug Delivery System." INTERNATIONAL JOURNAL OF DRUG DELIVERY TECHNOLOGY 14, no. 04 (2024): 1676–82. https://doi.org/10.25258/ijddt.14.4.64.
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Bilayer tablet technology is in focus because it advantageous for combination therapy, for combining two different release profile and it gives patent novelty to existing dosage. Hence its advantages, challenges and applications need to be discuss. The objective of preparing a review article on bilayer tablets is multifaceted, aiming to cover challenges at formulation development to scaleup and opportunity for new product development by integrating it bilayer tablet technology with other formulation technology. With reference to all the electronic data it was found that bilayer tablets face many challenges from formulation development till commercial manufacturing like interfacial bonding strength, layer separation, effect of environment on bonding strength bilayer tablet. But all these challenges can be over come by resolving appropriate remedies like using plastic diluent in both layers, manufacturing bilayer tablet using appropriate bilayer tablet manufacturing machine, etc. going forward with this challenges bilayer tablets puts advantage like it can be use for combination therapy, for chronotherapeutic therapy, enhancing therapeutic activity by altering micro environmental pH etc. Review comprises the information of key challenges to be consider while selection of excipients during formulation development, challenges related to process of bilayer tablet manufacturing and manufacturing bilayer tablet by integrating it with novel drug delivery systems and processes for enhancing therapeutic effectiveness and patient compliance
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Saha, Shreya, Mithun Bhowmick, and Rimpa Goswami. "Bilayer Tablet: Novel Technology Use in Extended Release Drug Delivery System." Journal of Drug Delivery and Therapeutics 9, no. 3-s (2019): 962–65. http://dx.doi.org/10.22270/jddt.v9i3-s.2877.
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Bilayer tablet is a successful technology of controlled release formulation or extended release formulation to provide successful drug delivery. The name of this development is clear that the tablets have been consisting of two layers, these are immediate release layer (IR) and another is extended release layer (ER). In this era it is very useful in many developing countries as a combination therapy for various disease treatment purposes. Bilayer tablet are needs to separate incompatible active pharmaceutical ingredients (API) by physical separation. In this formulation IR and ER both layers are present and it form extended release layer (ER). This types of formulations helps to maintain plasma level concentration in the body. So, it is a very useful and successful technology in novel drug delivery system. Keywords: Bilayer tablet, extended drug release, Tablet press,
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Subhash Tarate, Mr Vivek, and Dr Jagdishchandra Pati. "A Study on Bilayer Tablets for the Anti-Allergic Drug." Journal of Drug Discovery and Therapeutics 11, no. 2 (2023): 29–39. http://dx.doi.org/10.32553/jddt.v11i2.462.
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The bilayer tablet formulations used for each individual layer should be compressible (i.e., the capacity of a material to undergo a reduction in volume as a result of an applied pressure) and compactable (i.e., the capacity of a powder to be transformed into tablets with strength during densification) on their own, i.e., they should show satisfactory reduction in volume and form mechanically sound and coherent solid bodies. A bigger contact area exists between the layers as a result of the increased surface roughness, which improves interlayer adhesion. Bilayer tablet characterisation in early formulation development has certain advantages, including Bilayer tablet interfacial strength should be quantified, unusual or extreme properties of compacted layers should be identified, lot-to-lot consistency of the produced tablets should be ensured, rational formulation development strategy followed, material failure mechanisms during tablet manufacturing should be explained, and tablet-specific factors' effects should be understood.
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Journal, Devanshi, Dibya Kumari, and Umesh Kumar Jain. "Formulation and Evaluation of Gastroretentive Bilayer Tablets." Journal of Drug Delivery and Therapeutics 14, no. 9 (2024): 107–12. http://dx.doi.org/10.22270/jddt.v14i9.6784.
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Gastroretentive bilayer tablets were designed to prolong the gastric residence time after oral administration and to achieve immediate release of lansoprazole and controlled release floating layer of clarithromycin to treat gastric ulcers. Instant release layer has a combination of super disintegrating agents. A combination of effervescent mechanism is used. HPMC K5 was used as swelling polymer and citric acid, sodium bicarbonate as gas generating agent to reduce the floating lag time. Bilayer floating tablets were prepared with varying proportions of instant layer and sustained release floating approaches. The prepared formulations were evaluated for various tablet and floating parameters. Tablet properties were found to be within the limits according to procedures prescribed in USP. They had a floating lag time around 3-7 seconds and floating time more than 24 hours. The cumulative % drug release in simulated gastric fluids after 10 hours was 70% - 95%. The mechanism of drug release was analyzed by fitting the release data into various kinetic models. It was found that all the formulations best fit the Higuchi’s model. Keywords: Gastroretentive drug delivery system; Bilayer tables, Instant release layer, Floating layer, Lansoprazole, Clarithromycin.
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Ashish, Sonawane* Yashpal More Vaibhav Patil. "Formulation And Assessment of Oral Gel for The Treatment of Mouth Ulcer Using Extract from Jamun Seed Powder." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 3566–74. https://doi.org/10.5281/zenodo.15478930.
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A new era in the successful creation of controlled release formulations with many properties to offer an effective drug delivery mechanism began with the introduction of bilayer tablets. Bilayer tablets are superior to conventional mouthwash, sprays, and gels. Therefore, using a bilayer pill for analgesic and anti-inflammatory purposes is rather different. Two incompatible substances can be separated using bi-layer tablets, two treatments can be released successively, or sustained release tablets with an immediate release dose in the first layer and a maintenance dose in the second layer can be made. The flaws of a single layered tablet are addressed by the improved and practical bilayer tablet technology. In order to solve common bilayer issues such layer separation, inadequate hardness, imprecise individual layer control of weight, and cross contamination, this article discusses why Development and production of quality bi-layer tablets must be carried out on unique tablet presses due to issues with the layers, decreased yield, etc. thereby a high production output is needed, utilizing an altered tablet press may not be the best choice for producing a superior bilayer tablet under GMP conditions.
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Manish, Kumar Gupta, Ghadge Madhvi, Verma Sunil, and Singh Sudharshana. "FORMULATION AND EVALUATION OF BILAYER TABLETS FOR SUSTAINED RELEASE." International Journal of Current Pharmaceutical Review and Research 13, no. 3 (2021): 38–43. https://doi.org/10.5281/zenodo.12667170.
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Bi-layer tablet is a new era for successful development of controlled release formulationalong with various features to provide successful drug delivery. Bilayer layer tablets consistof two layers which are slow release and immediate release layers. It is an improvedtechnology to overcome the shortcoming of the single layer tablets and offer more benefits.The bilayer tablet helps to separate incompatible active pharmaceutical ingredient (APIs)from each other. Bilayer tablets material involves both the compressibility and consolidation.Bilayer formulations carry different drugs in each layer and deliver each of them without anypharmacokinetic or dynamic interactions, with their individual rate of delivery. Controlledrelease dosage forms have been extensively used to improve therapy with several importantdrugs
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Jamshiya.E*, and Anju.P. "FORMULATION, EVALUATION AND OPTIMIZATION OF FLOATING MATRIX TABLETS OF CARVEDILOL." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 02 (2018): 1146–58. https://doi.org/10.5281/zenodo.1188894.
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Bilayer floating tablets were prepared by direct compression using HPMC K100M and Ethyl cellulose as the release controlling polymers and sodium bicarbonate as a gas generating agent. The optimum concentrations of the above ingredients were determined under experimental conditions and on the basis of trial batches of the tablets. In the present study bilayer tablet was prepared manually using single station punching machine. Accurately weighed 150mg of sustained release layer powder mixture was fed manually into die cavity. Sustained release layer was compressed at mild compression force (2-3 kg/cm2 ). After that accurately weighed 100mg of immediate release powder mixture was manually fed into the die over sustained release layer and compressed. Eleven formulations were prepared and evaluated for various evaluation parameters of bilayer tablet for physical properties, floating and in vitro drug release. All the formulations showed optimum flow properties, percentage of weight variation and friability. Accordingly, the increase of sodium bicarbonate from 0.5 to 9 % in the polymer resulted in a decrease in FLT from 9 to 1 min (F1-F3). Because of the amount of sodium bicarbonate also affected the drug release from the formulation, F2 have optimum concentration (4.5%) of sodium bicarbonate. The drug release pattern and drug uniformity were found to be satisfactory. Considering the in vitro drug release studies batch F9 was selected as optimized formulation Keywords: Bilayer floating matrix tablet, carvedilol, HPMCK100M, Sodium bicarbonate, sodium starch glycolate
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Jangid, Vikash, Arindam Chatterjee, Saurabh Pandey, Vikash Agarwal, and Deeksha Sharma. "Formulation and Evaluation of Bi-Layer Tablet of Nebivolol and Nateglinide." Journal of Biomedical and Pharmaceutical Research 12, no. 3 (2023): 34–42. http://dx.doi.org/10.32553/jbpr.v12i3.993.
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In the present work, the Bilayered matrix type tablet were prepared by direct and wet granulation technique, in which immediate release layer ( by direct compression) contains Nebivolol and extended release layer (by wet granulation) contains Nateglinide. All the developed bilayer tablets were evaluated for weight variation, friability, thickness and hardness. The percent deviation from the average weight, friability, thickness and hardness was found to be within the prescribed official limits. Release profile of Nebivolol from formulations indicate that lower MCC (Formulations CF1 and CF3) and lactose (Formulation CF3) content displayed higher release rates as compared to formulation with higher MCC and lactose content (Formulation CF2). Also the concentration of KYRON T-314 is also found to influence the release rate of the drug. It was found that formulation containing the highest concentration of superdisintegrants (Formulation CF3) has grater release then other subsequent formulations (Formulations CF1 and CF3). Similarly, the release profile of Nateglinide from formulations indicate that lower HPMC K15M (Formulation CF3) and lactose (Formulation CF3) content displayed higher release rates as compared to formulation with individual HPMC K15M, HPMC K100M, EC (Formulations CF1 and CF2) and higher lactose content (Formulations CF1 and CF2).
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Akshay, Y. Sonawane Shubham S. Sonawane Jyoti Khapre. "Novel Approach And Current Applications Of Bilayer Tablet." International Journal in Pharmaceutical Sciences 2, no. 7 (2024): 1491–504. https://doi.org/10.5281/zenodo.12788774.
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The bi-layer tablet represents a new era in the successful creation of controlled release formulations with numerous characteristics to ensure successful drug delivery. Bi-layer tablets may be the best solution for avoiding chemical incompatibilities across APIs by physical separation and for developing distinct medication release patterns. A bi-layer tablet is appropriate for the sequential release of two medications in combination, as well as for the sustained release of a tablet, with one layer for rapid release as a loading dosage and the second layer for maintenance dose. As a result, the usage of bi-layer tablets is considerably different for anti-hypertensive, diabetic, anti-inflammatory, and analgesic medications, where combination therapy is frequently utilized. Several pharmaceutical firms are now developing bi-layer tablets for a number of reasons, including patent extension, therapeutic, and marketing. Although general tablet production principles remain the same, there is considerably more to consider since producing multi-layer tablets requires several, frequently incompatible components, extra equipment, and other formulation and operational issues. The current article introduces bi-layer tablet technology, challenges in bi-layer tablet manufacturing, various tablet presses used, various bi-layer Tabletting techniques, and current application in the field of bi-layer technology.
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Kim, Namhyuck, Kyoungho Kim, Seungwei Jeong, et al. "Development and Evaluation of Bilayer Sustained-Release Tablets of Ruxolitinib Using Discriminative Pharmacokinetic Analysis and IVIVC." Pharmaceutics 17, no. 4 (2025): 432. https://doi.org/10.3390/pharmaceutics17040432.
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Objectives: This study explores the development and evaluation of a bilayer sustained-release (SR) tablet formulation of ruxolitinib. As a BCS Class 1 drug, ruxolitinib requires twice-daily dosing due to its short half-life. We designed a bilayer tablet that integrates immediate-release (IR) and SR components in varying ratios to achieve sustained plasma concentrations, which we evaluated using discriminative analysis. Methods: Bilayer tablets combining IR and SR components were prepared in different ratios. In vitro dissolution tests and pharmacokinetic studies were conducted using Beagle dogs, followed by the evaluation of in vivo–in vitro correlation (IVIVC), along with a discriminative pharmacokinetic analysis focused on the SR layer. Results: A discriminative pharmacokinetic and IVIVC analysis was applied to all bilayer tablets, offering clearer insights into the plasma concentration and dissolution profiles. Pharmacokinetic studies showed that test formulation F4, which has a 20:20 IR-to-SR ratio, is expected to provide a similar area under the curve (AUC) while prolonging exposure compared to the reference IR tablet. Conclusions: This study highlights the potential of a bilayer tablet approach, combined with discriminative pharmacokinetic and IVIVC analysis, for creating a sustained-release dosage form of ruxolitinib.
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Dr., M. Sunitha Reddy* and Gadam Charitha. "FORMULATION AND IN-VITRO CHARACTERIZATION OF LOSARTAN POTASSIUM AND REPAGLINIDE BILAYER TABLETS." Indo American Journal of Pharmaceutical Sciences 04, no. 12 (2017): 4207–13. https://doi.org/10.5281/zenodo.1095022.
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The purpose of this study is to formulate and evaluate bilayer anti-hypertensive and anti-diabetic tablets. Bilayer tablet contains Losartan potassium for immediate release and Repaglinide for a sustained release. The bilayer tablets were prepared using crospovidone and sodium starch glycolate as super-disintegrants for the immediate release layer, hydroxyl propyl methyl cellulose K 100M and hydroxyl propyl methyl cellulose K 15M as polymers at various concentrations to retard the release of drug for a period of time. Immediate release layer was prepared by direct compression and wet granulation method was followed for sustained release. FTIR studies revealed that there was no incompatibility between drugs and excipients. The tablets were evaluated for weight variation test, hardness, thickness, friability, tablet disintegration time, content uniformity and in vitro dissolution studies. In vitro drug release studies were performed using the type-II dissolution apparatus (paddle) using 0.1N Hydrochloric acid for first 2 hours and the remaining hours with 6.8 pH phosphate buffer. Among all the formulations, optimized formulation F5 showed a maximum of 99.4% drug release at 45 minutes for Losartan potassium and Repaglinide has an in vitro drug release of 99.87%. Therefore, bilayer tablets in combination of these two drugs can be used to improve the management of hypertension (high blood pressure) and diabetes mellitus. –II. Keywords: Bilayer tablet, Losartan Potassium, Crospovidone, and Sodium starch glycolate, Repaglinide, Hydroxy propyl methyl cellulose K100M, Hydroxy propyl methyl cellulose K15M.
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Rajni, Dubey1 Saniya Mubarik*2 Bhaskar Kumar Gupta3 Mariya Beg1. "Formulation and Evaluation of By-Layered Tablet." International Journal of Pharmaceutical Sciences 3, no. 3 (2025): 2848–95. https://doi.org/10.5281/zenodo.15101573.
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Several pharmaceutical companies are currently developing bi- layer tablets for a variety of reasons like patent extension, therapeutic efficacy, marketing etc. This technology has been used to reduce capital investment. Modified tablet presses have been used to develop bilayer tablets in order to overcome problems associated with tablets like layer separation, insufficient hardness, inaccurate individual layer weight control, cross contamination between the layers, reduce yield etc. When high production output is required a modified tablet, press is used.
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Swetanshu, ,., and Vijay Sharma. "Formulation, Optimization and Evaluation of Bilayer Tablet of Antihypertensive Drug." Journal of Drug Delivery and Therapeutics 9, no. 4 (2019): 704–8. http://dx.doi.org/10.22270/jddt.v9i4.3098.
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Hypertension or high blood pressure occurs when the high cardiac output exerts pressure on the arterial wall as the blood flow increases. Bi-layer tablets are prepared with one layer of drug for immediate release while second layer designed to release drug later, either as second dose or in an extended release manner. Bi-layered tablet is suitable for sequential release of two drugs in combination, separate two incompatible substances, and also for sustained release tablet in which one layer is immediate release as initial dose and second layer is maintenance dose. Bilayer tablet is suitable for sequential release of two drugs in combination, separate two incompatible substances and also for sustained release tablet in which one Layer is immediate release as initial dose and second layer is maintenance dose. The preparation of tablets in the form of multi layers is used to provide systems for the administration of drugs.
 Keywords: Hypertension, Bi-layered tablet, Enalapril, Immediate release and Sustained release.
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Palla, Sai Sowjanya, Rajkumar Kotha, Anusha Paladugu, E. Rajesh Kumar Reddy, Suryasri Lavanya Adavi, and K. Ramamohan Reddy. "Bilayer Floating Tablets for Gastroretentive Drug Delivery System." International Journal of Pharmaceutical Sciences and Nanotechnology 6, no. 3 (2013): 2097–112. http://dx.doi.org/10.37285/ijpsn.2013.6.3.1.
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 Oral delivery of the drug is by far the most preferable route of drug delivery due to the ease of administration, patient compliance and flexibility in the formulations but has a drawback of non-site specificity and short gastric resident time. In recent years, scientific and technological advancements have been made in the development of novel drug delivery systems by overcoming physiological troubles such as short gastric residence times and unpredictable gastric emptying times. Among Several approaches of floating systems, Bilayer floating technology is considered as promising approach. It combines the principle of bilayer technology and floating mechanism. The combined principle of bilayer floating tablet helps to release initial dose from the immediate release layer to reach the plasma concentration and then the floating layer absorbs gastric fluid forming an impermeable colloidal gel barrier on its surface, maintains a bulk density less than unity and thereby remains buoyant in stomach providing steady state concentration of drug in system. This review focuses on bilayer floating tablet technology a new era of gastro retentive drug delivery system, its advantages over conventional tablets and it also summarizes the bilayer tablet presses used in the industry, formulation design and evaluation parameters of bilayer floating tablets.
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Sikdar, KM Yasif Kayes, Ahad Ahamed, Md Mahbubul Alam, Md Raihan Sarkar, and BK Sajeeb. "Formulation and In-vitro Evaluation of Bilayer Tablets of Atenolol and Amlodipine." Bangladesh Pharmaceutical Journal 22, no. 2 (2019): 153–69. http://dx.doi.org/10.3329/bpj.v22i2.42299.
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The present investigation was focused on formulation and in-vitro evaluation of a fixed dose bilayer tablet of two prominent antihypertensive agents, atenolol and amlodipine. The tablets were designed to immediately release atenolol (ATF1-ATF5) by using different percentage of sodium starch glycolate as super-disintegrant for prompt blood pressure lowering activity and sustain release amlodipine (AMF1- AMF5) by varying the percentage of hydroxy propyl methylcellulose (HPMC) for prolonged activity. After evaluation of the physical and chemical parameters of the formulations according to United States Pharmacopoeia (USP) guidelines, the best immediate release formulation was found in ATF1 in terms of dissolution (99.87% after 45 minutes) and other tablet properties like hardness, disintegration time, good flow properties etc. However, the best sustained release activity was found in AMF3 in terms of dissolution (99.98% after 24 hours with constant release) and other tablet properties. After optimization of the formulations, both atenolol and amlodipine parts were successfully compressed into bilayer tablets and post-compression parameters were evaluated. In 0.1 N HCl medium, the release of atenolol from bilayer tablet was found 98.97% after 45 minutes and in case of amlodipine it was found 98.12% in 0.1 N HCl medium followed by phosphate buffer medium after 24 hours. Drug release kinetics showed that the atenolol layer followed Case I, QasiFickian transport and amlodipine layer followed Anomalous (non-Fickian) transport. Compatibility study was conducted by using Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Calorimetry (DSC). Moreover, crystalline nature of substances and extent of its conversion to amorphous form was studied using X-ray Diffractometry (X-RD).
 Bangladesh Pharmaceutical Journal 22(2): 153-169, 2019
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JARTOLIA, PRIYANKA, SAPNA AVINASH KONDALKAR, AVINASH KRISHNRAO KONDALKAR, and MURAREE LAL. "FORMULATION AND DEVELOPMENT OF BILAYER FLOATING TABLET OF AMOXICILLIN." Current Research in Pharmaceutical Sciences 10, no. 4 (2020): 76–89. http://dx.doi.org/10.24092/crps.2020.100403.
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Bilayer floating tablet of amoxicillin was formulated successfully and evaluated under suitable parameters. All the batches of tablet produced were found to exhibit short floating lag times. The tablet of batch F2 exhibited a longer floating lag time of 23 minutes. Relationship between the dependent and independent variables was further elucidated using contour and response surface plots. Dissolution profiles that the tablets of batch F3, F7, and F12 exhibits initial burst phase during the first hour of dissolution. The burst phase was followed by a limited drug release for the rest of the period. Also it was observed during the dissolution studies that tablets of all three batches eroded quickly with increased effervescence. Time required for 50 % drug to get released (T50%) and %CR10hrs were found to be in the range of 0.7 to 8.6 hours and 57.35 ± 3.89 to 99.93 ± 0.07 respectively, value of “Prob > F” less than 0. 05. Response surface plots and Contour plot indicated that at a fixed level of B (35 mg) and low level of A (amount of HPMC), % CR10hrs increases from 68.11 to 90.00 % and T50% decrease from 6.86 to 1.66 as the amount of citric acid (C) increases from 0 to 10 mg. Stability study was performed for optimized formulation and it was found that formulation was stable for 6 week at 25 °C/ 60% RH. KEYWORDS: Bilayer floating tablet, amoxicillin, Evaluated, Multi-layered tablet, Stability
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Madhu, Rajak*, Amal Raj A., Singh Dhakad Rajendra, and Singh Rajput Hakim. "FORMULATION AND EVALUATION OF BILAYER TABLET OF ANTIHYPERTENSIVE DRUG." World Journal of Pharmaceutical Science and Research 3, no. 5 (2024): 440–53. https://doi.org/10.5281/zenodo.14050790.
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The aim of present study is to prepare bilayer tablets of Losartan Potassium with an immediate release and a sustained release layer. The immediate release layer was prepared using super disintegrant sodium starch glycolate and sustained release layer is formulated with different polymers. The bilayer tablets of losartan potassium were prepared by the direct compression method. The drug, polymers and other excipients used for both immediate (IR) and sustained release (SR) layers were passed through sieve #80 before their use in the formulation. The immediate dose of drug was calculated from total dose of losartan potassium extended release tablet, which is 50 mg. Losartan potassium can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg. in vitro dissolution was carried out using USP Dissolution testing apparatus type-II (Paddle method; Veego Scientific VDA-8DR, Mumbai, India). Different batches of tablets were prepared varying the different sustaining components that were considered to have significant effect on drug release. These bilayer tablets as well as the powder blends were subjected to various in-process quality control tests for evaluation of their different physical parameters. The release of losartan potassium from fast releasing layer was analyzed by plotting the cumulative percentage of drug release Vs time. It shows an effective initial burst effect from IR layer and released from this layer was completed within 10 minutes. Bi-layer tablet is improved beneficial technology to overcome the limitation of the single layered tablet.
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Singh, Neha, Durga Pandey, Nilesh Jain, and Surendra Jain. "Formulation and In Vitro Evaluation of Bilayer Tablets of Lansoprazole and Amoxycillin Trihydrate for the Treatment of Peptic Ulcer." Journal of Drug Delivery and Therapeutics 11, no. 1 (2021): 23–31. http://dx.doi.org/10.22270/jddt.v11i1.4481.
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The present work involves the formulation development, optimization and In-vitro evaluation of bilayer tablet containing Lansoprazole in the immediate release layer and Amoxycillin in the sustained release layer, using sodium starch glycolate as a super disintegrant for the immediate release layer and the hydrophilic matrix HPMC K100M, hydrophobic matrix Ethyl cellulose are used in the sustained release layer. Bilayer tablet showed as initial burst effect to provide dose of immediate release layer Lansoprazole to control the acid secretion level and the sustained release of Amoxycillin for 24 hours. Immediate and sustained release tablets were formulated by wet granulation method because of the poor flow property of the blends. The prepared bilayer tablet was evaluated for their precompression parameters, physical characteristics like hardness, friability, uniformity of weight, uniformity of drug content, swelling index, In-vitro floating studies and In-vitro drug release. The release of the lansoprazole from the immediate release layer was found to be 97.46 ± 0.15% in 15minutes. The release of Amoxycillin Trihydrate for the sustained release floating layer was found to be 98.25 ± 0.14% in 12 hours. Lansoprazole potentiate the effect of Amoxycillin. Hence the bilayer tablets of Lansoprazole and Amoxycillin were used to improve patient compliance towards the effective management of ulcer.
 Keywords: bilayer tablet, Lansoprazole, and Amoxycillin, sustained release
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M.Toma, Nawar, and Yehia I.Khalil. "Formulation and Evaluation of Bilayer Tablets Containing Immediate Release Aspirin Layer and Floating Clopidogrel Layer." Iraqi Journal of Pharmaceutical Sciences ( P-ISSN 1683 - 3597 E-ISSN 2521 - 3512) 22, no. 1 (2017): 40–49. http://dx.doi.org/10.31351/vol22iss1pp40-49.
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Aspirin and clopidogrel are considered the most important oral platelets aggregation inhibitors. So it is widely used for treatment and prophylaxis of cardiovascular and peripheral vascular diseases related to platelets aggregation .In this study aspirin and clopidogrel were formulated together as floating bilayer tablet system. Three different formulas of 75 mg aspirin were prepared by wet granulation method as immediate release layer; different disintegrants used to achieve rapid disintegration. Formula with crosscarmellose as disintegrant achieve rapid disintegration was selected for preparation of bilayer tablet.
 Different formulas of 75 mg clopidogrel were prepared as sustained release floating layer by wet granulation (effervescent ) method ;the physical and floating properties for compressed clopidogrel matrix were studied in addition to study the effect of polymer concentration(HPMC) ,and its combination with ethyl cellulose and carbapol ,effect of different diluents and effect of increasing sodium bicarbonate amount on the release from compressed matrix .
 Formula prepared with HPMC and EC in a ratio of 1:1 was capable to retard the release of clopidogrel for 6 hours in addition to its good floating behavior and therefore selected to prepare bilayer tablets in combination with selected aspirin layer.
 The prepared bilayer tablets were further subjected to evaluation of their physical, floating properties and release behavior. Finally the kinetic study reflects acceptable shelf life for aspirin and clopidogrel.
 Key words: Aspirin, Clopidogrel, Bilayer tablet, Floating tablet.
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Das, Manoj Kr, Bhanu P. Sahu, and Jahan Nur Rahman Hazarika. "DEVELOPMENT OF BILAYER TABLETS FOR IMMEDIATE AND CONTROLLED RELEASE OF ALLICIN." International Journal of Current Pharmaceutical Research 9, no. 4 (2017): 153. http://dx.doi.org/10.22159/ijcpr.2017v9i4.20982.
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Objective: The purpose of this study was to develop and evaluate bilayer tablet for the immediate and controlled release of Allicin (Garlic Extract) for effective treatment of Hypertension.Methods: The immediate release layer was prepared by using super disintegrants-sodium starch glycolate and binder used xantham gum and the sustained release layer was prepared by using hydrophilic polymer like HPMC K 100 and PVP. Before preparation of the tablets, all the pre-formulation parameters were checked and the tablet of Allicin were prepared by direct compression method and was evaluated for physical characteristics like hardness, weight variation, drug content and friability. In vitro release of drug was performed USP type II dissolution test apparatus using phosphate buffer (pH 7.4) as dissolution media and dissolution was continued for 8 hrs for the sustained release layer.Results: It was found that all the formulations were within the limit of the standard. The drug release of the tablet was in the range of 66%-83% in 8 h.Conclusion: It was concluded that the F4 formulation showed the optimum result as a bilayer tablet for the effective treatment of hypertension.
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Chandan, Singh* Rita Saini Shivanand Patil. "A Review of Bilayer Tablet Technology Immediate and Extended-Release Drug Delivery." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 4491–503. https://doi.org/10.5281/zenodo.15534239.
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Compared to monotherapy (traditional dosage forms), combination therapy is more common and has several benefits. The best and most recent example of mixed dose formulation is bilayer tablet technology. The pharmaceutical industry has seen a rise in single-dose formulation that combines 2 or 3 molecules within the tablets. By lowering the number of dosages and increasing the bioavailability of dosage forms, it is well known for encouraging patient convenience and compliance. Innovative variations of traditional oral drug delivery technologies are bilayer or multilayer tablets. The only technology that has been used in various APIs for synergistic effects, to improve bioavailability, to physically separate incompatible substances to prevent interaction, and to allow for development of various drug release profiles. This paper aims to provide a broad overview of the creation and manufacturing of bilayer tablet technology, highlighting the challenges faced in the manufacturing process and outlining anticipated solutions.
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Ullah, Ghufran, Asif Nawaz, Muhammad Shahid Latif, et al. "Clarithromycin and Pantoprazole Gastro-Retentive Floating Bilayer Tablet for the Treatment of Helicobacter Pylori: Formulation and Characterization." Gels 9, no. 1 (2023): 43. http://dx.doi.org/10.3390/gels9010043.
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Bilayer/multilayer tablets have been introduced to formulate incompatible components for compound preparations, but they are now more commonly used to tailor drug release. This research aimed to formulate a novel gastro-retentive tablet to deliver a combination of a fixed dose of two drugs to eliminate Helicobacter pylori (H. pylori) in the gastrointestinal tract. The bilayer tablets were prepared by means of the direct compression technique. The controlled-release bilayer tablets were prepared using various hydrophilic swellable polymers (sodium alginate, chitosan, and HPMC-K15M) alone and in combination to investigate the percent of swelling behavior and average drug release. The weight of the controlled-release floating layer was 500 mg, whereas the weight of the floating tablets of pantoprazole was 100 mg. To develop the most-effective formulation, the effects of the experimental components on the floating lag time, the total floating time, T 50%, and the amount of drug release were investigated. The drugs’ and excipients’ compatibilities were evaluated using ATR-FTIR and DSC. Pre-compression and post-compression testing were carried out for the prepared tablets, and they were subjected to in vitro characterization studies. The pantoprazole layer of the prepared tablet demonstrated drug release (95%) in 2 h, whereas clarithromycin demonstrated sustained drug release (83%) for up to 24 h (F7). The present study concluded that the combination of sodium alginate, chitosan, and HPMC polymers (1:1:1) resulted in a gastro-retentive and controlled-release drug delivery system of the drug combination. Thus, the formulation of the floating bilayer tablets successfully resulted in a biphasic drug release. Moreover, the formulation (F7) offered the combination of two drugs in a single-tablet formulation containing various polymers (sodium alginate, chitosan, and HPMC polymers) as the best treatment option for local infections such as gastric ulcers.
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Umamaheswara Rao T, Smitha M, Maghiben M, and Damodara Velayudham A. "Analysis on the evaluation of aceclofenac bilayer tablets and its formulation using FT-IT method." International Journal of Research in Pharmaceutical Sciences 11, SPL4 (2020): 323–28. http://dx.doi.org/10.26452/ijrps.v11ispl4.3798.
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The detached of the current research progress a bilayer tablet of aceclofenac utilizing sodium starch glycolate (SSG) and croscarmellose sodium (CCS) as super disintegrants for the formulation of immediate-release layer whereas polymers such as methocel K15M, Lubrizol 971P were utilized by the formulation of sustaining layer. The tablets were equipped by straight density technique. The organized tablets were estimated for pre-compressed parameters like micromeritic properties and post compressed parameters like bulk variation, aceclofenac satisfied and in-vitro dissolution studies. The in-vitro dissolution studies showed about 86.78 % of aceclofenac release from the bilayer tablet, indicating that a preliminary burst release of aceclofenac followed by sustaining action up to 12 h by the sustained layer of the tablets. In-Vitro kinetic data revealed that all the formulations surveyed the Higuchi prototype via fickian dispersal as announcement device subsequently the preliminary rupture announcement. FT-IR studies exposed here is no communication among the drug and polymers utilized in the study. The errand of medication is to safeguard and reestablish wellbeing and to soothe languishing. In this context, the most commonly used pain-relieving agent is aceclofenac an NSAID. In the present investigation, aceclofenac bilayer tablets were prepared to provide sustain effect for better therapeutic effect. These points of interest, clarify the requirement for the planning of changed medication conveyance framework.
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Gorde, V. D., Punit R. Rachh, Someshwar Mankar, Saurin Amin, and Prasad L. Gorde. "Formulation and development of bilayer tablet containing irbesartan and metformin hydrochloride for diabetic hypertensive patients." Journal of Applied Pharmaceutical Research 12, no. 4 (2024): 66–74. http://dx.doi.org/10.69857/joapr.v12i4.589.
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Background: Hypertension is a common complication of type II diabetes. The present research work aimed to develop bilayer tablets that would manage type II diabetes patients with hypertension. The prepared bilayer tablet has an immediate-release layer of anti-hypertensive irbesartan and a sustained-release (SR) layer of anti-diabetic metformin hydrochloride. The purpose of these bilayer tablets was to increase patient compliance by converting two separate monotherapy to single combination therapy. Methodology: Several ratios of polymers, including HPMC K100M, EC, Eudragit, and Guar gum, were employed to prolong the drug release for twelve hours. An immediate-release layer of irbesartan was prepared by spherical agglomeration. The physical properties, drug content, solubility profiles, release kinetics, and stability of prepared bilayer tablets were assessed. Results and Discussion: The examination of SR granules and bilayer tablets revealed outstanding packing qualities and excellent flow properties, with bulk and tapped densities ranging from 0.39-0.46 g/cm³ and 0.42-0.55 g/cm³, respectively. In vitro dissolution tests revealed that the immediate-release layer gave an initial burst of Irbesartan. Still, the sustained-release layer of metformin showed controlled drug release over 12 hours at greater polymer concentrations. According to stability testing, the bilayer tablets' physical properties, drug content, and dissolving profiles did not change significantly. Conclusion: The bilayer tablet combination of Irbesartan and Metformin exhibited desired physical features, controlled drug release, and stability. This formulation represents a viable treatment option for diabetic hypertensive patients, offering effective and consistent management of both disorders while improving patient compliance.
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Parashar, Tarun, and Nardev Singh. "FORMULATION AND IN VITRO EVALUATION OF BILAYER TABLET OF ATENOLOL FOR BIPHASIC DRUG RELEASE." Asian Journal of Pharmaceutical and Clinical Research 11, no. 5 (2018): 114. http://dx.doi.org/10.22159/ajpcr.2018.v11i5.22975.
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Objective: In the present research work, the aim was to prepare the bilayer tablet of atenolol for biphasic drug release to improve its bioavailability and absorption in the lower gastrointestinal tract. Methods: In the formulation of immediate release crospovidone, croscarmellose sodium, and sodium starch glycolate was used as super disintegrate and was directly compressed. For a sustained release portion different grade hydroxypropyl methylcellulose (HPMC) K4M, HPMC K15M, gum tragacanth, gum acacia, guar gum, and ethyl cellulose. Preformulation studies were performed before compression. The compressed bilayer tablets were evaluated for weight variation, dimension, hardness, friability, drug content, disintegration time, and in vitro drug release using USP dissolution apparatus type 2 (paddle). Results: The formulation IR3 showed 95% drug release in 30 min, and regression coefficient value (r2) value was found to be 0.994 suggesting first-order drug release kinetics. The F9 formulation using HPMC K15M and gum acacia (1:1) showed 91.20% drug release at the end of 12 h, and regression coefficient value (r2) was 0.992 suggesting zero-order drug release kinetics. Formulation IR3F9 showed faster drug release for bilayer tablet containing 5%w/w crospovidone in immediate release layer and HPMC and guar gum (1:1) in sustained release. Formulation IR3F9 showed swelling index 206%, floating lag time was found to be 2 min and total floating time up to 12 h. Conclusion: The formulation IR3F9 showed a faster drug release profile among the others in the preparation of the atenolol bilayer tablet. Hence, it was considered as an optimized formulation.
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Arti, Parmar* Akanksha jagwani Toshiba Khanam Narendra Gehalot Vikas Jain. "COMPREHENSIVE REVIEW ON FORMULATION AND MANUFACTURING TECHNIQUES OF BILAYER TABLETS." International Journal in Pharmaceutical Sciences 2, no. 8 (2024): 3117–21. https://doi.org/10.5281/zenodo.13316959.
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Bilayer tablets are an inventive and adaptable drug delivery device because they have two layers, each with a unique drug release profile. This review summarises the development, manufacturing processes, formulation strategies, and pharmaceutical uses of bilayer tablets. Carefully choosing formulation ingredients is essential to the effectiveness of these tablets, taking into account medication compatibility as well as the effects of formulation variables on stability and bioavailability. A range of manufacturing approaches are examined, emphasising their scalability and appropriateness for certain medication classes. These techniques include direct compression, compression coating, and stacking. The reliability of bilayer tablets is mostly dependent on quality control, which emphasises friability, disintegration, and dissolving testing. Bilayer tablets have been used pharmaceutically to treat problems of the central nervous system, the heart, and the gastrointestinal tract, proving their effectiveness in treating complicated medical illnesses. Novel approaches to medication delivery have been made possible by recent developments in bilayer tablet technology, including the incorporation of developing materials and applications of nanotechnology. Exciting future potential include personalised medical techniques and the use of 3D printing technology for customised bilayer tablets. To sum up, this extensive analysis offers a complete grasp of bilayer tablets and offers insightful information about their production, composition, and range of medical uses. By combining cutting-edge technologies, bilayer tablets are positioned as a flexible and promising drug delivery method that will promote improvements in patient-specific therapies and enhance treatment results.
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Amit, Pareek, and Kumar Gupta Mukesh. "An Overview of The Bilayer Tablet." International Journal of Current Pharmaceutical Review and Research 14, no. 04 (2022): 106–10. https://doi.org/10.5281/zenodo.12657682.
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In the history of the development of the controlled release formulation, the introductionof bilayer tablets marked the beginning of a new age. This innovation, in alongside otherfactors, has made it possible to successfully provide medications to the body. Through the useof physical separation, such as bilayer tablets, it is possible to prevent chemicalincompatibilities between API. Additionally, new pharmaceutical release patterns may bedeveloped. This article provides an overview of the most recent developments in thetechnology behind bilayer tablets, with a primary emphasis on the most significant benefitsoffered by oral dosage forms. The bilayer tablet may be used for a variety of purposes, and itscomposition can either be a monolithic matrix that is partly covered or a multilayered matrix.This article provides a concise overview of the general characteristics, benefits, drawbacks,types, evaluation considerations, and manufacturing processes associated with bilayer tabs,along with the most current developments in this field of technology
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Israr, Muhammad, Nicola Pugliese, Arshad Farid, et al. "Preparation and Characterization of Controlled-Release Floating Bilayer Tablets of Esomeprazole and Clarithromycin." Molecules 27, no. 10 (2022): 3242. http://dx.doi.org/10.3390/molecules27103242.
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Controlled-release effervescent floating bilayer tablets reduce dosage frequency and improve patient compliance with enhanced therapeutic outcomes. Generally, two different tablets of clarithromycin and esomeprazole, respectively, are given for the treatment of Helicobacter pylori infection and it might be worth incorporating both in a single tablet. In the current study, controlled-release floating bilayer tablets of clarithromycin and esomeprazole (F1–F4) were developed with different rates of polymeric materials by a direct compression method. During the formulation, Fourier-transform infrared spectroscopy (FTIR) analysis was performed for possible interactions between drugs and excipients. No interactions between drugs and excipients were noted. Moreover, the bilayer tablets’ thickness, diameter, friability, hardness, weight variation, dissolution, and percent purity were found within the acceptable limits. The floating lag time and total floating time of all formulations were found to be < 25 s and 24 h, respectively. The release of both the clarithromycin and esomeprazole started at the same time from the controlled-release floating bilayer tablets by anomalous non-Fickian diffusion, and the polymeric materials extended the drug release rate up to 24 h. In the case of F1, the results approached ideal zero-order kinetics. The dissolution profiles of the tested and reference tablet formulations were compared, but no significant differences were observed. It can be concluded that such controlled-release effervescent floating bilayer tablets can be efficiently used in clinical practice to reduce dosage frequency and increase patient compliance with continuous drug release for 24 h, which ultimately might enhance therapeutic efficacy.
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Mahata, Jaydip, Jeevan Patel, Ramakant Sharma, and Rakesh Patel. "Formulation and Evaluation of Bilayer Tablet of Saxagliptin." International Journal of Pharmaceutical Sciences and Medicine 7, no. 5 (2022): 72–86. http://dx.doi.org/10.47760/ijpsm.2022.v07i05.007.
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In the present study Saxagliptin 60mg tablets have been formulated and developed using direct compression and dry granulation technique, to provide a safe, highly effective method for treating congestive heart failure, edema and kidney disorder, while reducing undesirable adverse effects. Pre and post formulation parameters were studied for the formulated batches. The result of all the physical and in-vitro dissolution data concluded that bilayer tablet (I3,S9) was the most promising formulation. The trial conducted with the consecutive three batches for immediate release and sustained release revealed relative standard deviation below 2 %, indicative the insignificant batch-to-batch variation that can be overcome if processes are run out in a controlled manner. Using Crosspovidone as super disintegrate and HPMC as sustained release polymer blend would be cost effective and dissolution mediums 0.1N HCl would the ideal media for conducting dissolution studies. It was concluded that the bilayer tablet formulation can be act as a better tool for the successful administration of two or more drug which will remain stable for longer period of time.
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Amit, Pareek, and Kumar Gupta Mukesh. "An Overview of The Bilayer Tablet." International Journal of Current Pharmaceutical Review and Research 14, no. 4 (2022): 106–10. https://doi.org/10.5281/zenodo.7612899.
Full textAbstract:
In the history of the development of the controlled release formulation, the introduction of bilayer tablets marked the beginning of a new age. This innovation, in alongside other factors, has made it possible to successfully provide medications to the body. Through the use of physical separation, such as bilayer tablets, it is possible to prevent chemical incompatibilities between API. Additionally, new pharmaceutical release patterns may be developed. This article provides an overview of the most recent developments in the technology behind bilayer tablets, with a primary emphasis on the most significant benefits offered by oral dosage forms. The bilayer tablet may be used for a variety of purposes, and its composition can either be a monolithic matrix that is partly covered or a multilayered matrix. This article provides a concise overview of the general characteristics, benefits, drawbacks, types, evaluation considerations, and manufacturing processes associated with bilayer tabs, along with the most current developments in this field of technology.
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Mayur, Aware, Gondkar Sheetal, and Bachhav Rishikesh. "Bilayer Floating Tablet : A Novel Floating Tablet." International Journal in Pharmaceutical Sciences 1, no. 1 (2022): 86–93. https://doi.org/10.5281/zenodo.5895074.
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Out of various drug delivery system the novel drug delivery system is overcomes and then physiological problems of gastric retention by decreasing fluctuations in blood drug concentration level with consequent reduction in the undesirable toxicity and poor efficiency. Approaches have their been introduced to prolong gastric residence time such as the floating system, modified shape, swelling index, expanding system and high density system. Two layer floating drug delivery system is combined principle of bilayer tablet as well as floating mechanism. Bilayer floating tablet is new in the era for the successful development of the controlled release formulation along with the different features to provide a way of successful drug delivery system. The purpose of this paper is to the following Review of the principle of floating drug delivery system, current technology used in the development of same as well as summarizes in the applications, advantages and disadvantages, characterization, evaluation methods and future potential for the bilayer floating tablets.
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Lodha, Gaurav S., and Satyam Z. Chemate. "Formulation and Evaluation of Teneligliptin and Telmisartan Bilayer Tablets for the Treatment of Coexistent Type II Diabetes Mellitus and Hypertension." Journal of Drug Delivery and Therapeutics 9, no. 5 (2019): 26–38. http://dx.doi.org/10.22270/jddt.v9i5.3537.
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In the current scenario type two diabetes mellitus and hypertension have become prevalent in large number of population. But there are many patients which are suffering from Type II Diabetes Mellitus as well as hypertension. Such condition is called co-existent Type II Diabetes Mellitus and Hypertension. In the present work an attempt is made to treat co-existent type II Diabetes Mellitus and hypertension by formulating a Bilayer tablet of Teneligliptin and Telmisartan. Both drugs are sustained released to give a day long relief to the patients and to also reduce the dose frequency. Both the layers of the tablets were formulated by wet granulation method. The granules were tested for angle of repose, bulk density, tapped density, compressibility and Hausner’s ratio to check their efficacy. Eleven different types of formulations were made using various polymers and excipients with the drugs such as PVP K30, HPMC K4M, Starch, Crospovidone, Lactose, Mannitol, Talc and Magnesium Stearate. From these 11 formulations F6 showed better tablet characteristics and drug release rate than other formulations. Thus F6 is the best formulation in this study. Biological screening of the drugs combination of Teneligliptin and Telmisartan was also done to check the presence of antidiabetic activity of the combination which showed positive results.
 Keywords: - Teneligliptin, Telmisartan, Sustained, Bilayer.
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Naveen, Kumar HR, Kumar P. Ashok, V. Kulkarni Suresh, and K. Manjunath. "Development and Evaluation of Floating Sustained Release Bilayer Tablets Containing Drotaverine HCl." American Journal of PharmTech Research 12, no. 06 (2022): 62–74. https://doi.org/10.5281/zenodo.7407644.
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ABSTRACT Bilayer floating tablets of Drotaverine HCL were developed by direct compression method. Immediate release layer contains 20 mg of drug and super disintegrant sodium starch glycolate, serves the purpose of loading dose. Sustained release layer contained HPMC K100, natural polymers like xanthan gum, guar gum, karaya gum release the drug for 12 hours’ time. Sodium bicarbonate and citric acid are used to produce effervescence. Floating lag time of optimized tablet is 92 sec, whereas floating duration is more than 12 hours. FTIR results revealed that there was no interaction between drug and HPMC K100 / xanthan gum. The post compression parameters of developed tablets were found to be satisfactory. In this study, it was confirmed that the formulations containing HPMC K100, have shown better floating properties and finally the formulation containing a combination of HPMC K100 and xanthan gum in 3:1 ratio, has exhibited decent sustained drug release properties. The release kinetics of optimized formulation prepared with the combination of HPMC K100 and xanthan gum followed zero order kinetics. <strong>Keywords: </strong>Floating Bilayer Tablet, Drotaverine HCL, HPMC K100, Xanthan Gum, FTIR.
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S. Jabbar, Mohammed, and Yehia I. Khalil. "Formulation of Metoprolol Bilayer Tablets as an Oral Modified Release Dosage Form." Iraqi Journal of Pharmaceutical Sciences ( P-ISSN: 1683 - 3597 , E-ISSN : 2521 - 3512) 19, no. 1 (2017): 21–30. http://dx.doi.org/10.31351/vol19iss1pp21-30.
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Metoprolol is a β1 adrenergic blocker used in treatment of heart diseases. Metoprolol (100mg) tablets was formulated as a modified release oral system utilizing the concept of bilayer system, first layer contained (30mg) as immediate release and the other (70mg) in the sustained release matrix. The immediate release layer consisted of lactose or microcrystalline cellulose as diluents with sodium starch glycolate or sodium croscarmellose as disintegrants. The result showed that the layer contains microcrystalline cellulose and 2% sodium starch glycolate gave disintegration time similar to that of conventional metoprolol tartrate tablet. This result was subjected in the subsequent preparation of the bilayer tablet. The sustained release layer was prepared using three polymers: ethylcellulose (EC), Hydroxypropyl methylcellulose (HPMC) and hydroxyl ethylcellulose (HEC) as retardant materials. It was found that the combination of EC with HPMC in ratio of 2:1 in F11 was best formula because of it’s release profile and the tablet integrity and dimensions were conserved for the period of the test, but according to similarity factor (f Â2Â), F15 (which contained EC:HPMC in ratio 2:1 with polyvinyl pyrrolidone (PVP) as a binder) was the best formula showed higher (f2Â) among all other formulas and equals to 72.3 comparing to reference product.
 Key words: Metoprolol, Bilayer tablet, Immediate release, Sustained release.
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P, Pavazhaviji, and Rajalakshmi A. N. "FIXED-DOSE COMBINATION DRUGS AS TABLET IN TABLET: A REVIEW." International journal of multidisciplinary advanced scientific research and innovation 1, no. 9 (2021): 169–77. http://dx.doi.org/10.53633/ijmasri.2021.1.9.02.
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The Pharmaceutical industry has become more interested in developing fixed-dose combinations (FDCs) in recent years. FDCs have been used successfully in a variety of clinical areas, including diabetes, HIV/AIDS,and cardiovascular diseases etc. FDCs are intended to extend the product life cycle and enhance patient compliance by decreasing cost. Active Pharmaceutical ingredients are chosen for FDC development based on variety of purposes such as Pharmacokinetic profile, drug-drug interactions, mechanism of action, and manufacturability for successful development. Tablet in tablet technology has gained popularity in recent years for creating modified release products. The compression coating or solvent-free-coating technology is also known as Tablet in Tablet technology. Tablet in Tablet technology is presently the finest alternative technology for the formulation of bilayer tablets for physical separation of active medicines and used to avoid chemical incompatibilities and to produce different drug release patterns such as rapid release, sustained release, controlled release, delayed release, and pulsatile release. This review mainly focuses on combining the techniques of both FDC and Tablet in Tablet formulations which offer a wide variety of benefits such as increased patient compliance, convenience, separation of incompatible ingredients, avoiding close interaction of two drugs, achieving various drug release patterns and maximizing the potency of both drugs over conventional oral dosage forms Keywords: Fixed dose combinations, Tablet in tablet technology, Compression coated tablet, Bilayer tablet, delayed release
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B, Vijaya Kumar, Prasad G, Ganesh B, Swathi C, Rashmi A, and Amarender Reddy G. "Development and Evaluation of Guaifenesin Bilayer Tablet." International Journal of Pharmaceutical Sciences and Nanotechnology 3, no. 3 (2010): 1122–28. http://dx.doi.org/10.37285/ijpsn.2010.3.3.10.
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The objective of the present research was to develop a Bilayer tablet of guaifenesin (GBT) using superdisintegrant MCC and sodium starch glycolate for the fast release layer and metalose 90 SH and carbopol 934 for the sustaining layer. The guaifenesin SR granules of different formulation were evaluated for bulk density, tapped density, angle of repose, Carr’s index and Hausners ratio and results were found to be 0.460 ± 0.12 to 0.515 ± 0.03 gm/cm3 , 0.550 ±0.03 to 0.590 ±0.04 gm/cm3 , 19 ±0.01 to 26 ± 0.23, 13.72 ± 0.03 to 19.56 ± 0.04 & 1.137 to 1.196, respectively. The prepared bilayer tablets were evaluated for weight variation, hardness, friability, drug content and in vitro drug release. In vitro dissolution studies were carried out in a USP 24 apparatus I. The formulations gave an initial burst effect to provide the loading dose of the drug followed by sustained release for 12 h from the sustaining layer of matrix embedded tablets. In vitro dissolution kinetics followed the Higuchi model via a non-Fickian diffusion controlled release mechanism after the initial burst release. Stability studies conducted for optimized formulation did not show any change in physical appearance, drug content, matrix integrity and in vitro drug release. The results of the present study clearly indicated that GBT was a stable dosage form and a promising potential of the guaifenesin bilayer system as an alternative to the conventional dosage forms
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Rayakwar, Neetesh, and Yuvraj Singh Dangi. "Development and characterization of controlled release bilayered tablets of Citicoline sodium." Journal of Drug Delivery and Therapeutics 9, no. 2-s (2019): 125–31. http://dx.doi.org/10.22270/jddt.v9i2-s.2471.
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Objectives: The aim of present investigation was formulation development and evaluation of bi-layer tablets of citicoline sodium. Materials and Methods: An aqueous granulation process was adopted to formulate citicoline sodium (CTS) bilayer tablets. Wet granulation method has been utilized for the formulation of bilayer CTS tablet. Citicoline sodium, microcrystalline cellulose (pH 101 & 102), HPMC K4, K15, K-100, PVP K-30, Magnesium stearate, cross-carmellose sodium, sodium starch glycolate and red oxide were used for preparation. Pre-formulation studies of citicoline sodium and drug excipient compatibility study was carried to optimize the formulation variables. Two layers, immediate release (IR layer) and sustained release (SR) has been developed and evaluated for the various parameters e.g. micromeritic properties, percentage yield, particle size, hardness, thickness, weight variation, percent friability and percent assay, In-vitro dissolution and In-vitro release studies. Result and Discussion: Pre-formulation study of citicoline sodium denotes that evaluated parameters confirm the suitability and compliance of drug with polymers. Drug excipient compatibility study through the DSC confirmed that polymer, excipient and drug were compatible with each other and no incompatibility issue found during the preparation of formulation. FT-IR study is also executed to confirm the drug-excipient incompatibility. In all physical mixtures of drug and polymer, there was neither masking of single characteristic peak nor existence of additional peak in drug spectra; this has proven that drug and polymers are compatible with each other. Hardness 10-11 kg/cm2, thickness 7.3-7.4 mm, percent weight variation 1.2%, friability 0.1-0.3%, assay was 99-101% denotes the successful development of CTS tablets. Conclusion: These all parameters denote that the formulation has optimized, evaluated and were in the standard range. Hence, this optimized bilayer tablet formulation could be a potential formulation to promote sustained release, promote delivery of drugs from a single dosage form to improve patient compliance and give better disease management. Keywords: Citicoline sodium, bi-layer tablet, DSC, immediate release, sustain release.
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R, Shireesh Kiran, bathool Saleha, Geetha K, and Sharma GS. "Formulation and Evaluation of Bilayer Anti-Diabetic Tablet of Murayya Koeinigii and Spinach Olaracea." International Journal of Pharmaceutical and Bio-Medical Science 03, no. 10 (2023): 521–29. https://doi.org/10.5281/zenodo.10245277.
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The purpose of this study was to develop and evaluate bilayer tablet for the immediate and controlled release of murayya koeinigii and spinach oleracea for effective treatment of diabeties (Type 2). The immediate release layer was prepared by using super disintegrants- starch powder and the sustained release layer was prepared by using polymer like acaia, HPMC E5 and Methyl cellulose. Before preparation of the tablets, all the preformulation parameters were checked and the tablet of murayya koeinigii and spinach oleracea were prepared by direct compression method and was evaluated for physical characteristics like hardness, weight variation, drug content and friability. In vitro release of drug was performed USP type II dissolution test apparatus using distilled water buffer as dissolution media and dissolution was continued for 10 hrs for the sustained release layer. It was found that all the formulations were within the limit of the standard. The drug release of the tablet was in the range of 67%-99% in 10 h. The drug release pattern of formulation F5 was fitted in different kinetic models which showed highest regression for zero order kinetics with Koresmeyer Peppas through non-fickian type of drug release mechanism. Hence It was concluded that the F5 formulation showed the optimum result as a bilayer tablet for the effective treatment of diabeties (Type 2).
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Niranjan, Abadhesh Kumar, and Alka Singh. "Formulation, Development and Evaluation of Bilayer Floating Tablets of Antihypertensive Drug Bosentan." Journal of Drug Delivery and Therapeutics 11, no. 6 (2021): 167–72. http://dx.doi.org/10.22270/jddt.v11i6.5113.
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Hypertension, or high blood pressure, is a major public health concern around the world because of its large contribution to the global health burden and its function as a major risk factor for a variety of disease processes. Bosentan SR Floating Bilayer Tablets were made with HPMC K4M, HPMC E-15, and HPMC E-15 alone (80%) and in combination with varying percentages of polymer (20&60 percent, 40&40 percent, and 60&20 percent ). The hydrophilic polymer HPMC is used to make three different formulations (M4, M8, and M12) of floating Bosentan SR tablets, each with a viscosity grade of 80 percent. M12 formulation was shown to be suitable for SR tablet formulation. From the M12 formulation. It's based on the M12 formula. The fraction of high viscosity polymer can be lowered by adding low viscosity polymer, as demonstrated in the C3 formulation. It was clear from the dissolution profile of formulation C3 that by mixing the low and high viscosity polymers, the drug release from the formulation may be improved as compared to manufacturing M12 high viscosity polymer alone. According to the findings of this investigation, as floating duration increases, the release rate drops. As a result, it's appropriate for long-term formulation.
 Keywords: Bosentan, Floating Bilayer Tablets, Hypertension, SR Tablets, HPMC K4M, E-15
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Aniket, Ravindra Pawar*, Bundela Ragini, and Karunakar Shukla Dr. "FORMULATION AND EVALUATION OF BILAYER TABLET OF NATEGLINIDE." World Journal of Pharmaceutical Science and Research 3, no. 6 (2024): 143–49. https://doi.org/10.5281/zenodo.14252787.
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The main objective of research work is to develop a bilayer tablet of Nateglinide, in which one layer is immediate layer for immediate action and second layer is the sustain release layer for maintaining the dose of the drug. Preformulation study was performing for various parameters like melting point, Bulk density, Tapped density. Carr’s index, Housner ratio etc. Bilayer tablets were prepared in two stages by using Crosspovidone different viscosity grades of hydroxy propyl methyl cellulose (HPMC) viz., K4M and K100M. The prepared Bilayer tablets were evaluated for hardness, bulk density, tapped density, friability, uniformity of weight, drug content, in vitro dissolution and drug-polymer interaction. Immediate layer drug content result was found to be 4.89±0.152 kg/cm2 and 99.26 ±1.42. On the basis of disintegration and dissolution studies, I 3 was found to be superior amongst them which show disintegration time 28 ±2.10 second and 98% drug release and sustain layer drug content result was found for S3 5.4 ±0.31 kg/cm2and 97.86 ±0.90, for S6 5.5±0.52 kg/cm2 and 97.55±1.59 and for S9 5.5±0.15 kg/cm2 and 98.25±1.53 respectively, but for further refinement the batches were subjected for dissolution studies. On the basis of dissolution studies, the S9 batch was found to be superior amongst them which show 95 % drug release in 24 hours.
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Ferdousi, Fatiha Momtaz, Farhani Safrin, Md Nawshed Ali, Abdullah Al Juhan, and Priyanka Akter. "Composition and Drug Release Characteristics of Bi-layered and Multi-layered Tablets: A Comprehensive Review." Journal of Drug Delivery and Therapeutics 15, no. 1 (2025): 169–76. https://doi.org/10.22270/jddt.v15i1.6936.
Full textAbstract:
Multilayer and Bilayer tablets are winning popularity over single-layer tablets because of their controlled release advantages. Since each layer of API must be compatible with the others and with excipients to extend the effects of the medication or drugs and improve patient compliance, technology for creating multilayers and bilayers is less widespread than that for single-layer tablets. Hydrophilic polymers are more frequently employed in the formulation of biliary and multilayer tablets as both medication carriers and release barriers. But the ratio of using polymer is different from each other in the drug barrier layer and carrier layer that can make alteration by a researcher to develop a difference in the release rate of different APIs in a single unit of the tablet. With a larger surface area and a faster rate of drug release over time, multilayer and biliary tablets can help mitigate the non-linearity and drug interactions that arise with diffusion-controlled matrix devices. This review article covers the different techniques used to create biliary and multilayered tablets as well as the challenges associated with their formulation. Keywords: Multi-layer tablets, Bi-layer tablets, Drug release, Tablet manufacturing
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Sadhu, Venkateswara Rao, Priyanka Bopparaju, and Padmalatha Kantamneni. "Bilayer tablet technology: A novel approach." GSC Biological and Pharmaceutical Sciences 7, no. 2 (2019): 022–28. https://doi.org/10.5281/zenodo.4286145.
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Bilayer tablet is new era for the successful development of controlled release formulation along with various features to provide a way of successful drug delivery system. Controlled release dosage forms have been extensively used to improve therapy with several important drugs. Use of bilayer tablet is a very different aspect for anti-inflammatory and analgesic. Bilayer tablet is suitable for sequential release of two drugs in combination, separate two incompatible substances and also for sustained release tablet in which one Layer is immediate release as initial dose and second layer is maintenance dose. Bilayer tablet is improved beneficial technology to overcome the shortcoming of the single layered tablet. This article provides an overview of the bilayer tablet technology, highlighting the main benefits of this type of oral dosage forms while providing a description of current challenges and advances toward improving manufacturing practices and product quality.
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Ganesh, Nayak1* Akshay Killekar2 Krishnananda Kamath K.1 A. R. Shabaraya1 Viresh Chandur1. "Formulation And Evaluation of a Bilayer Mucoadhesive Buccal Drug Delivery System for Carvedilol Nanoparticles." International Journal of Pharmaceutical Sciences 2, no. 12 (2024): 54–62. https://doi.org/10.5281/zenodo.14254155.
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The main objective of this study was to formulate carvedilol nanoparticles into mucoadhesive bilayer tablets and evaluate the nanoparticle-loaded formulation. This approach aims to address the challenges of low solubility, poor bioavailability, and first-pass metabolism associated with carvedilol when administered in conventional oral dosage forms. Carvedilol nanoparticles were prepared using the nanoprecipitation method, as described in Ganesh R. Nayak et al. (Int. J. of Pharm. Sci., 2024, Vol. 2, Issue 7, 2010-2018). Bilayer buccal tablets were then prepared by direct compression and evaluated for their physicochemical properties. In vitro studies demonstrated that the carvedilol buccal tablet formulation containing nanoparticles could serve as a promising drug delivery system.
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Soni, Nikita, Deepak Joshi, Vikas Jain, and Pradeep Pal. "A Review on Applications of Bilayer Tablet Technology for Drug Combinations." Journal of Drug Delivery and Therapeutics 12, no. 1 (2022): 222–27. http://dx.doi.org/10.22270/jddt.v12i1.5206.
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Bilayer tablets are novel drug delivery systems where combination of two drugs in a single unit having different release profiles can be delivered. Bilayer tablets improve patient compliance, prolong the drug(s) action and can deliver two incompatible drugs in a single formulation. Bilayer tablets have one layer of active ingredient for immediate release and a second layer for delayed release, either as a second dose or in an extended release fashion. Bilayer tablets are advancing helpful technologies to overcome the disadvantages of single-layered tablets. However, bilayer tablet technology is resource-intensive. A thorough selection of excipients and manufacturing conditions for each technical stage is also required. Patients with high blood pressure often have difficulty or are unable to regulate their BP with just a single medication. The majority of hypertension patients will need to take two or more antihypertensive medicines in order to meet treatment goals. Combinations of antihypertensive drugs from various categories have been found to be more effective than either drug alone in treating hypertension in people whose blood pressure cannot be maintained satisfactorily with monotherapy. Combining two antihypertensive medications with mutually beneficial mechanisms of action may result in much greater blood pressure lowering efficacy than any of these components alone. The goal of this review is to discuss the use of bilayer tablets to administer fixed antihypertensive drug combinations for the treatment of high blood pressure.
 Keywords: Bilayer tablet, blood pressure, antihypertensive drugs, Sustained release, maintenance dose.
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Rekha, K. Wakhare* Anand D. Savkare Priyanka R. Nighute Priyanka S. Pagar. "FORMULATION AND DEVELOPMENT OF STABLE DOSAGE FORM OF AMLODIPINE BESYALTE AND BENAZEPRIL HYDROCHLORIDE TO OVERCOME PHYSICAL INCOMPATIBILITY." INDO AMERICAN JOURNAL OF PHARMACEUTICAL RESEARCH 07, no. 09 (2017): 504–22. https://doi.org/10.5281/zenodo.1036488.
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Amlodipine is a dihydropyridine calcium channel blocker with a slow onset and long duration of action. Benazepril hydrochloride is an angiotensin- converting enzyme inhibitor. But the Amlodipine besylate and Benazepril are physically incompatible drugs so there is need to keep them physically separated in dosage form. There are various approaches to overcome incompatibility. Among which the bilayer tablet is one of the novel, suitable approach and increasing attention from a variety of industries for various reasons viz. The purpose of this research is to study the physical incompatibility between Amlodipine and Benazepril, to formulate and develop the dosage form that overcome the incompatibility .the incompatibility study was carried by mixing two drugs in 1:1 and 1:2 ratio and then stored at 40 0C±0.20C and relative humidity 75%±0.5%. The samples were examined for physical changes, pH, and IR studies at particular time of intervals. Photographs of samples are taken at particular interval. From incompatibility study it was concluded that the bilayer tablet is the suitable approach to overcome the incompatibility. In the bilayer tablets physical separation is achieved by coating the Benazepril hydrochloride granules with the gelatin and then formulating bilayer tablets to minimize contact between Amlodipine besylate and Benazepril hydrochloride leads to overcome physical incompatibility. Tablets were prepared by direct compression. A 32 Full factorial design was employed to systematically optimize the drug release profile, hardness and disintegration time. The stability study conducted for optimized formulation is stable having no impact on physical incompatibility.
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Agam, Kumar Chaubey* Ashok Baghel Dinesh Sharma Yogendra Singh. "Formulation And Evaluation of Bi-Layered Tablet of Divalproex Sodium." International Journal of Pharmaceutical Sciences 3, no. 3 (2025): 501–13. https://doi.org/10.5281/zenodo.14993024.
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The pharmacokinetic advantage relies on the criterion that, drug release from the fast-releasing layer leads to a sudden rise in the blood concentration. However, the blood level is maintained at steady state as the release from sustained layer. Particularly bilayer tablets are commonly used to avoid chemical incompatibilities of formulation components by physical separation, and release profile. The tablet is the most widely used dosage form because of its convenience in terms of self-administration, compactness and ease in manufacturing.4 Tablets are solid dosage forms containing medicinal substances with or without suitable diluents.5 According to Indian Pharmacopoeia Pharmaceutical tablets are solid, flat or biconvex dishes, unit dosage form, prepared by compressing a drugs or a mixture of drugs, with or without diluents.6 They are varying in size and weight, depending on amount of medicinal substances and the intended mode of administration. It is most popular dosage form and 70% of the total medicines are dispensed in the form of tablet There are different types of tablets are available in market conventional tablet, immediate tablet, fast dissolving tablet, controlled release tablet, sustained release tablet, delayed release tablet.Immediate release tablets are those which disintegrate rapidly and get dissolved to release the medicaments.10 For immediate release formulation, super disintegrants play key component. Super disintegrants are used to improve the efficacy of solid dosage form. This achieved by various mechanisms, swelling, porosity and capillary action, heat of wetting, particle repulsion forces, deformation recovery, enzymatic reaction by which the tablets are broken into small particles.
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Harish Choodappa and Subramanian Somaskandan. "Formulation and evaluation of bilayer tablets: Glimepiride in floating drug delivery and Metformin in sustained release." International Journal of Research in Pharmaceutical Sciences 10, no. 3 (2019): 1602–7. http://dx.doi.org/10.26452/ijrps.v10i3.1319.
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In this study, we aimed to prepare bilayer tablets of Glimepiride in floating drug delivery and Metformin in sustained release formulation. Glimepiride is chosen in floating drug delivery to overcome the gastric irritation and gastric emptying time. Glimepiride was prepared by different polymers such as guar gum, xanthan gum, carbopol and sodium bicarbonate act as effervescent agent, and other excipients were mixed and compressed by direct compression as the first layer. Metformin was chosen in sustained release to reduce dose frequency using different polymer HPMC K100M, methylcellulose, PVP K30 in different ratio and other excipients were mixed and compressed as the second layer. The first layer and second layer are combined as a bilayer tablet. Tablets were evaluated for hardness, friability, thickness, weight variation; the In vitro studies were done for all formulation. Among all formulation, F2 was selected as best formulation and release kinetics studies were evaluated for formulation F2.
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Arunkumar, Selvi, L. Srinivas, D. Satyavati, and C. Emmanuel. "Formulation and Evaluation of Bilayer Matrix Tablets of Nebivolol Hydrochloride and Valsartan." Journal of Drug Delivery and Therapeutics 9, no. 4-s (2019): 82–93. http://dx.doi.org/10.22270/jddt.v9i4-s.3257.
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The present study is an attempt to develop bilayer matrix tablets of Nebivolol Hydrochloride and Valsartan with immediate release for Nebivolol Hydrochloride and sustained release for Valsartan. Superdisintegrants such as sodium starch glycolate and Crosscarmellose sodium were evaluated for immediate release of Nebivolol Hydrochloride and polymers HPMC K100M and K4M for sustained release of Valsartan. Preformulation studies were performed prior to compression. The compressed bilayer tablets were evaluated for weight variation, thickness, hardness, friability, drug content and in vitro drug release using USP dissolution apparatus type 2 in 0.01N HCl and phosphate buffer pH 6.8. All the pre and post compression parameters were found to be within the acceptable limits. The results of dissolution show that the formulations B3 was the best of all immediate and sustained release layer batches. The release kinetics of Valsartan was subject to curve fitting analysis in order to identify the best fit kinetic model. The regression analysis proves that the best formulations follow zero order release and drug release by diffusion process based on Fick’s law of diffusion. The data for stability studies infer no considerable change in drug content and dissolution rates as per ICH guidelines. The best formulation B3 was subjected to in vivo pharmacokinetic studies in rabbit model. In vitro, In vivo correlation (IVIVC) showed considerable linearity. Hence a novel bilayer tablet formulation of Nebivolol Hydrochloride and Valsartan was successfully developed by combining both immediate (IR) and sustained (SR) release layers.
 Keywords: Bilayer tablets, fixed unit dosage form, Nebivolol hydrochloride, Valsartan, LC-MS analysis.
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Aakash, Kumar Sirohi. "Controlled Release Tablet for the Treatment of Type-2 Diabetes Mellitus-A Review." International Journal of Pharmacy and Biological Sciences (IJPBS) 14, no. 1 (2024): 24–32. https://doi.org/10.5281/zenodo.10682346.
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Abstract Type-2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder that demands precise and sustained control of blood glucose levels. This abstract discusses the formulation and development of controlled release tablets for the treatment of T2DM. The focus lies on selecting appropriate antidiabetic drugs, designing formulations with controlled drug release mechanisms, and employing polymers and innovative delivery systems to achieve prolonged therapeutic effects. Various strategies, including osmotic pump systems, bilayer tablets, and gastroretentive systems, are explored to optimize drug release kinetics. Emphasis is placed on biocompatibility, safety, and regulatory compliance, ensuring that the developed formulations meet both efficacy and safety standards. The goal is to enhance patient compliance by providing a convenient and effective treatment option for individuals with Type-2 Diabetes Mellitus. The comprehensive approach discussed herein integrates pharmacological principles, formulation science, and regulatory considerations for the successful development of controlled release tablets tailored for the management of T2DM. <strong> </strong> <strong>Keywords </strong> Controlled release, Tablet formulation, Type-2 Diabetes Mellitus (T2DM), Antidiabetic drugs, Drug release kinetics, Polymers and Osmotic pump systems