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Journal articles on the topic 'Hard gelatin capsules'

Author: Grafiati

Published: 4 June 2021

Last updated: 15 June 2025

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1

Nurilmala, Mala, Noviyan Darmawan, Erin Apriliani Wulandari Putri, Agoes M. Jacoeb, and Tun Tedja Irawadi. "Pangasius Fish Skin and Swim Bladder as Gelatin Sources for Hard Capsule Material." International Journal of Biomaterials 2021 (August 27, 2021): 1–6. http://dx.doi.org/10.1155/2021/6658002.

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In this paper, we report the extraction and characterization of gelatin from the abundant industrial fishery waste of Pangasius skin and swim bladder and its application as the base material for hard capsule shells. The yield of gelatin ranged between 19 and 23%, content of moisture is 7.6–9.2%, ash is 1.1–1.7%, pH is 4.1–5.2, gel strength is 238–278 bloom, and viscosity is 65–74.7% mP. SDS-PAGE showed all gelatins have chains of α1, α2, and β-peptides. The skin, swim bladder, and mixed gelatins were successfully used in the production of hard capsule shells. The dimensions, weight, disintegration time, and water content properties of the hard capsules from these Pangasius wastes were akin to the standards of commercial capsules.

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2

Controulis, John, and Parke Davis. "Hard Gelatin Capsules – New Developments from Capsugel." Drug Development and Industrial Pharmacy 11, no. 2-3 (1985): 585–90. http://dx.doi.org/10.3109/03639048509056889.

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3

Kaur, Darshan. "FORMULATION AND EVALUATION OF HARD GELATIN CAPSULES CONTAINING Bacopa Monnieri." INTERNATIONAL JOURNAL OF PHARMACEUTICAL EDUCATION AND RESEARCH (IJPER) 1, no. 02 (2020): 33–37. http://dx.doi.org/10.37021/ijper.v1i2.2.

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Introduction: The present work deals the formulation of hard gelatin capsules containing granules of Brahmi (Bacopa monnieri). Bacopa monnieri is used in Ayurvedic traditional medicine to improve memory and to treat various ailments. The aim of the project is to achieve immediate release of drug from dosage form to achieve therapeutic efficacy and patient compliance. Hard gelatin capsules offer rapid drug release and protection from atmospheric oxygen. Materials and methods: In this work we have prepared the granules of Brahmi and filled into the empty hard gelatin capsule shells. The hard gelatin capsules were then evaluated for dissolution studies, disintegration study, drug content and weight variation. Results and Discussion: After dissolution study it was found that 93.46% of Brahmi was released within 90 min. The kinetics of drug release was also studied and it was found to follow Korsmeyer Peppas model.

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4

Al-Tabakha, Moawia M. "HPMC Capsules: Current Status and Future Prospects." Journal of Pharmacy & Pharmaceutical Sciences 13, no. 3 (2010): 428. http://dx.doi.org/10.18433/j3k881.

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Hydroxypropyl methylcellulose (HPMC) is employed for a wide variety of pharmaceutical and food preparations. Its applications as viscolizing agent (thickening agent), coating polymer, bioadhesive, in solid dispersion to enhance solubility, binder in the process of granulation and in modified release formulations have been well documented. One other notable use is in the production of capsule shells, replacing the animal derived gelatin in conventional two-piece capsules. The aim of this review is to systemically survey published literature on the HPMC use in capsule shells and resolve questions regarding their suitability as a replacement for hard gelatin capsules. Future refinements in the production and filling of HPMC capsule shells and improvement in their in vivo/in vitro dissolution would ensure their superiority over hard gelatin capsules.

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5

Uchimura, Érica Mayumi Takase, Irene Harumi Kamata Barcelos, Deborah Brandão de Paiva, Lucia Figueiredo Mourão, and Agricio Nubiato Crespo. "Evaluation of the location of capsules swallowed with food during the pharyngeal phase triggering in asymptomatic adults." CoDAS 26, no. 6 (2014): 476–80. http://dx.doi.org/10.1590/2317-1782/20140000045.

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OBJECTIVE: To assess the location of hard gelatin capsules in the pharyngeal phase triggering among asymptomatic adults. INTRODUCTION: The location of the bolus during the pharyngeal phase triggering provides information about the sensorimotor model of the beginning of deglutition onset. PURPOSE: To evaluate the location of hard gelatin capsules in the pharyngeal phase triggering among asymptomatic adults. METHODS: A videofluoroscopy swallowing study was carried out in 60 subjects (14 male and 46 female participants) aged between 27 and 55 years, who were evaluated with hard gelatin capsules #00 and #3 containing barium sulfate, swallowed with liquid food and pudding, in free volume. The first laryngeal elevation movement was the criterion to locate the pharyngeal phase triggering. Statistical analysis was based on the McNemar test. RESULTS: Capsule #3 presented higher percentage of location in the tongue dorsum compared to capsule #00, and capsule #00 presented higher percentage of location in the tongue base and vallecula compared to capsule #3. There was a difference between different capsules swallowed with liquid (p=0.016) and pudding (p=0.037). CONCLUSION: The capsule size influenced the location of the pharyngeal phase triggering. Smaller capsules started pharyngeal phase in the most anterior region (tongue dorsum) compared to larger capsules.

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6

Majee, Sutapa Biswas, Dhruti Avlani, and Gopa Roy Biswas. "HPMC AS CAPSULE SHELL MATERIAL: PHYSICOCHEMICAL, PHARMACEUTICAL AND BIOPHARMACEUTICAL PROPERTIES." International Journal of Pharmacy and Pharmaceutical Sciences 9, no. 10 (2017): 1. http://dx.doi.org/10.22159/ijpps.2017v9i10.20707.

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The most common instability problem of gelatin capsules arises from negative impact of extremes of temperature and especially atmospheric relative humidity on the mechanical integrity of the capsule shells with adverse effect extended even to the fill material. Moreover, choice of fill materials is highly restricted either due to their specific chemical structure, physical state or hygroscopicity. Additional reports of unpredictable disintegration and dissolution of filled hard gelatin capsules in experimental studies have prompted the search for a better alternative capsule shell material. The present review aims to provide an overview on the physicochemical, pharmaceutical and biopharmaceutical properties of hydroxypropyl methylcellulose (HPMC) as capsule shell material and perform comparative evaluation of HPMC and gelatin in terms of in vitro/in vivo performance and storage stability. HPMC capsule provides a highly flexible and widely acceptable platform capable of solving numerous challenges currently facing the pharmaceutical and nutraceutical industries and expands the possibilities for selection of different types of fill materials. The current topic introduces a new section on influence of various factors on in vitro dissolution of HPMC capsules. Delayed in vitro disintegration/dissolution of HPMC capsules in aqueous medium does not produce any negative effect in vivo. However, advancements in the processes of production and filling of HPMC capsule shells and detailed studies on effects of various parameters on their in vitro/in vivo dissolution would establish their supremacy over hard gelatin capsules in future.

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7

Y, Madhusudan Rao, Vinay Kumar K, Jagan Mohan S, and Kiran Kumar V. "Formulation and Evaluation of Extended Release Trihexyphenidyl Hydrochloride Hard Gelatin Capsules." International Journal of Pharmaceutical Sciences and Nanotechnology 4, no. 1 (2011): 1359–67. http://dx.doi.org/10.37285/ijpsn.2011.4.1.8.

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This work aims at investigating different types and levels of hydrophilic high molecular weight matrix agents, (including HPMC K15M, Metalose-60 SH, Metalose-65 SH and Metalose-90SH-SR), hydrophobic diluent (Talc) and formulation methods (Non-aqueous granulation and direct filling by simple mere mixture) in an attempt to formulate hard gelatin extended release matrix capsules containing Trihexyphenidyl HCl (Benzhexol). The drug release from all the extended release matrix capsules show polymer as well as talc concentration dependent retardation affect. The Metalose 90SH-SR concentration was optimized to approximately 27% w/w of total capsule net content weight. The hydrophobic diluent’s talc concentration was optimized and the useful concentration was approximately 17.45% w/w of the total net capsule content weight. The lactose concentration was also optimized and the effective concentration was found to be approximately 48.36% w/w. The prepared hard gelatin extended release capsules were evaluated for weight variation, Average net content, locked length, content uniformity, assay (drug content) and in-vitro drug release studies. From the in-vitro release studies of the prepared formulations, one formula was optimized from each method. All the formulations showed linear release profiles and extended the release of trihexyphenidyl HCl (Benzhexol) over 10 –12 h. The release profiles of extended release matrix capsules of trihexyphenidyl HCl (THP HCl) from the selected formulations were close to zero order and follow diffusion dependent release. The prepared extended release matrix capsules of trihexyphenidyl HCl (Benzhexol) produced from the optimized formulations ‘NAG-M90SH-SR-5 and DB M90SH-SR-4’ complied with the USP XXVII specifications. The difference factor (f1) and similarity factor (f2) was calculated for all these formulations and found to the below 15 and above 50. Irrespective of the formulation method type and its procedure, the prepared hydrophilic extended release matrix capsules showed non-Fickian anomalous transport (coupled diffusion in the hydrated matrix and polymer relaxation) as the values of release exponent (n) are in between 0.50 and 0.89. Finally it was clear that it is possible to design a formulation with any of the above two methods giving the desired drug release profile suggesting that nonaqueous granulation, Direct filling were good methods for preparing extended release matrix capsules of trihexyphenidyl HCl (Benzhexol).

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8

Rogowska, Magdalena, Karol Iwaniak, Andrzej Polski, et al. "Influence of different excipients on the properties of hard gelatin capsules with metamizole sodium." Current Issues in Pharmacy and Medical Sciences 29, no. 3 (2016): 114–17. http://dx.doi.org/10.1515/cipms-2016-0023.

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Abstract Metamizole is an effective non-opioid analgesic drug used in the treatment of acute and chronic pain. Due to induced potentially life-threatening blood disorders, metamizole was withdrawn from market in many parts of the world, however, it is one of the most popular analgesics in Poland that is available as an over the counter drug. Patients tend to prefer capsules over tablets, as they are easier to swallow and taste better. The powder-filled capsules also have greater bioavailability and require less excipients, as compared to tablets. Polymic excipients are mainly used in capsule filling, and have influence upon the physico-chemical properties of the hard gelatin capsules and the powder formulation. The aim of the study was to determine whether various combinations of polymers impact the disintegration time and pharmaceutical availability of hard gelatin capsules with metamizole sodium. The results of our work demonstrated that the 80% of all active substance was released in all tested formulations within 15 minutes. Herein, the capsule containing lactose monohydrate had the longest release (4% after 2 min.), while capsules containing mannitol had the fastest release (81.2% after 2 min.). Moreover, the addition of HPMC to capsules with lactose brought about a slight increase in the metamizole release rate, while the addition of PVP 30 to capsules with microcrystalline cellulose slightly accelerated release. This data suggests that the use of different polymers in capsules formulation brings about changes in the physical properties of powders and modifies the release profile of metamizole. In our study, the most preferred formulation was one containing microcrystalline cellulose (good powder properties and fairly fast release).

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9

Susanti, Tri, Siti Wafiroh, Esti Hendradi, and Pratiwi Pudjiastuti. "Characterization and release profile of sodium diclofenac halal hard shell capsules made from k-carrageenan and xanthan gum with sorbitol plasticizer." Journal of Halal Product and Research 3, no. 1 (2020): 1. http://dx.doi.org/10.20473/jhpr.vol.3-issue.1.1-8.

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Halal hard shell capsules are importantly needed by Indonesian consumers, who are predominantly Muslim, to substitute mostly used and commercially available products made from non-halal ingredients such as gelatin. The objective of this study is to prepare, characterize, and evaluate halal hard shell capsules made from k-carrageenan-xanthan gum with sorbitol as the plasticizer with diclofenac sodium as the model drug. Hardshell capsules were prepared with combinations of κ-carrageenan-xanthan gum at a weight ratio of 4:2 with the addition of 70% sorbitol, which added at a varied volume of 0.25; 0.50; 0.75; and 1.00 mL. Characterization of halal hard shell capsules includes swelling degree, tensile strength, Fourier Transformed Infrared (FTIR) and Scanning Electron Microscope (SEM), as well as disintegration test. The diclofenac sodium profile release was evaluated through the dissolution test at pH 6.8. The best physical characteristics were obtained by preparing capsule shells with a mixture of carrageenan-xanthan gum at a weight ratio of 4:2 with the addition of 0.25 mL sorbitol. The evaluation of Halal hard shell capsules showed that it had a swelling rate of 3.46% in water media, stress modulus of 28.6 MPa, strain modulus of 4.3 MPa, and modulus young of 362,3%, as well as disintegration time of capsules, was 51.8 minutes at pH 6.8. The dissolution test showed that diclofenac sodium was released at a level of 2.7% for 16 minutes. Based on this data, it can be concluded that the Halal hard shell capsule of κ-carrageenan-xanthan gum with the addition of sorbitol can be used as an alternative for the gelatin capsule with more controlled release.

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10

Sonar, S. P., S. B. Gondkar, and R. B. Saudagar. "Formulation and Evaluation of Liquid Filled Hard Gelatin Capsule of Febuxostat." Journal of Drug Delivery and Therapeutics 9, no. 5 (2019): 105–9. http://dx.doi.org/10.22270/jddt.v9i5.3579.

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Liquid filled hard gelatin capsule are well recognized as a solid dosage form for convenient administration of drugs orally in a liquid form. This liquid composition available help the most challenging drug compounds in capsules has increased significantly in recent years. The drugs which have low solubility, poor bioavailability, low melting point, critical stability are the perfect candidate for liquid filling in capsule. The current study presents the formulation aspects, filling and sealing aspects of capsule, evaluation parameters of the liquid filled hard gelatin capsule using Febuxostat as drug, oils (Arachis oil, Coconut oil, Olive oil) as solvents, Glyceryl monostearate as solubilizing agent, Butylated hydroxy toluene as antioxidant, Methyl paraben & Propyl paraben as preservatives. A capsule formed F3 formulation shows maximum drug release and drug content among all the formulations. Keywords: Liquid filled hard gelatin capsule, Febuxostat, Arachis oil, Coconut oil, Olive oil, Glyceryl monostearate, Butylated hydroxy toluene, Methyl paraben, Propyl paraben.

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11

Cadé, D., E. T. Cole, J. Ph Mayer, and F. Wittwer. "Liquid Filled and Sealed Hard Gelatin Capsules." Drug Development and Industrial Pharmacy 12, no. 11-13 (1986): 2289–300. http://dx.doi.org/10.3109/03639048609042636.

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12

Butkevičiūtė, Aurita, Mindaugas Liaudanskas, Kristina Ramanauskienė, and Valdimaras Janulis. "Biopharmaceutical Evaluation of Capsules with Lyophilized Apple Powder." Molecules 26, no. 4 (2021): 1095. http://dx.doi.org/10.3390/molecules26041095.

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Apples are an important source of biologically active compounds. Consequently, we decided to model hard gelatin capsules with lyophilized apple powder by using different excipients and to evaluate the release kinetics of phenolic compounds. The apple slices of “Ligol” cultivar were immediately frozen in a freezer (at −35°C) with air circulation and were lyophilized with a sublimator at the pressure of 0.01 mbar (condenser temperature, −85°C). Lyophilized apple powder was used as an active substance filled into hard gelatin capsules. We conducted capsule disintegration and dissolution tests to evaluate the quality of apple lyophilizate-containing capsules of different encapsulating content. Individual phenolic compounds can be arranged in the following descending order according to the amount released from the capsules of different compositions: chlorogenic acid > rutin > avicularin > hyperoside > phloridzin > quercitrin > (−)-epicatechin > isoquercitrin. Chlorogenic acid was the compound that was released in the highest amounts from capsules of different encapsulating content: its released amounts ranged from 68.4 to 640.3 μg/mL. According to the obtained data, when hypromellose content ranged from 29% to 41% of the capsule mass, the capsules disintegrated within less than 30 min, and such amounts of hypromellose did not prolong the release of phenolic compounds. Based on the results of the dissolution test, the capsules can be classified as fast-dissolving preparations, as more than 85% of the active substances were released within 30 min.

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13

Fauzi, Muhammad Al Rizqi Dharma, Pratiwi Pudjiastuti, Esti Hendradi, Riyanto Teguh Widodo, and Mohd Cairul Iqbal Mohd Amin. "Characterization, Disintegration, and Dissolution Analyses of Carrageenan-Based Hard-Shell Capsules Cross-Linked with Maltodextrin as a Potential Alternative Drug Delivery System." International Journal of Polymer Science 2020 (March 12, 2020): 1–7. http://dx.doi.org/10.1155/2020/3565931.

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Hard-shell capsules commonly consist of gelatin which is not a universal material considering it is extracted from animal parts. Moreover, the mad cow disease triggered the scrutinization of the use of gelatin in pharmaceutical products. Hence, an alternative to conventional hard-shell capsules is needed. Carrageenan- (CRG-) based hard-shell capsules were successfully prepared by cross-linking CRG with maltodextrin (MD) and plasticizing with sorbitol (SOR). These CRG-MD/SOR hard-shell capsules were produced as an alternative to conventional hard-shell capsules in the oral drug delivery system (DDS). The physical properties of CRG-MD/SOR capsules were characterized using the degree of swelling, FTIR, and SEM analyses. The disintegration and dissolution profile release of paracetamol from CRG-MD/SOR hard-shell capsules was performed in an aqueous medium with three different pH levels. The degree of swelling of CRG-MD/SOR was 529.23±128.10%. The main peaks in the FTIR spectrum of CRG-MD/SOR were at 1248, 930, 847, and 805 cm−1 for ester sulfate groups, 3,6-anhydrogalactose, galactose-4-sulfate, and 3,6-anhydrogalactose-2-sulfate, respectively. The SEM analysis exhibited minuscule pores on the surface of CRG and CRG-MD/SOR at 5000 times of magnification. The CRG-MD/SOR capsules required 18.47±0.11 min on average to disintegrate. The CRG-MD/SOR dissolution was better in a weakly acidic medium (pH 4.5) than in a strongly acidic (pH 1.2) and neutral (pH 6.8) media. Based on the aforementioned results, CRG-MD/SOR capsules are the potential candidate to replace conventional hard-shell capsules.

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14

Gupta, Rajkumar. "STEPS FOR SUCCESS IN SOURCING OF HARD GELATIN CAPSULES FOR PHARMACEUTICAL USE." International Journal of Drug Regulatory Affairs 2, no. 1 (2018): 32–36. http://dx.doi.org/10.22270/ijdra.v2i1.123.

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The sourcing of raw Gelatin for manufacturing hard Gelatin Capsules is a very critical function. It involves a thorough quality audit of the suppliers. The most critical audit points are: source of Gelatin used, quality control and quality assurance procedures, packaging system and storage conditions. In addition to these the facility shall be checked for domestic and international quality certifications and advance quality features.

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15

Isabel Hernández-González, Sandra, Jesús Iván García-Castañeda, José de Jesús Alba-Romero, Aurora Martínez-Romero, Rodolfo Gerardo Chew-Madinaveitia, and José Luis Ortega-Sanchez. "Manufacture of Hard Gelatin Capsules From a Lyophilisate of the Morus Nigra Fruit." Sumerianz Journal of Medical and Healthcare, no. 42 (June 7, 2021): 109–13. http://dx.doi.org/10.47752/sjmh.42.109.113.

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Morus nigra L. (M. nigra L.) belongs to the Moraceae family. Traditional medicine for its physicochemical properties. To evaluate the physicochemical composition and pharmaceutical stability of hard gelatin capsules of the freeze-dried fruit of M. nigra L. The content of total phenols (CFT) and antioxidant capacity (CA) were evaluated by spectrophotometry, the content of ash, moisture, protein, fat and fiber were determined according to their own standard. The CFT and CA were 25.4 mg gallic acid equivalents/g of sample, and 74.1% inhibition, respectively. On the other hand, the values of ash, moisture, protein, fat and fiber were 4.2%, 7.9%, 3.9%, 0.5% and 3.6%, respectively. Lyophilized M. nigra fruit may be a novel candidate for the development of gelatin hard capsules and other new pharmaceutical products.

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Caviglioli, Gabriele, Brunella Parodi, Valeria Posocco, Sergio Cafaggi, and Gaetano Bignardi. "Stability Study of Hard Gelatin Capsules Containing Retinoic Acid." Drug Development and Industrial Pharmacy 26, no. 9 (2000): 995–1001. http://dx.doi.org/10.1081/ddc-100101328.

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17

SMITH, A., J. LAMPARD, K. CARRUTHERS, and P. REGAN. "The filling of molten ibuprofen into hard gelatin capsules." International Journal of Pharmaceutics 59, no. 2 (1990): 115–19. http://dx.doi.org/10.1016/0378-5173(90)90085-i.

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18

Prasad, V. Deva. "Formulation and modifying drug release from Hard and Soft Gelatin Capsules for Oral drug delivery." International Journal of Research and Development in Pharmacy & Life Sciences 06, no. 04 (2017): 2663–77. http://dx.doi.org/10.21276/ijrdpl.2278-0238.2017.6(4).2663-2677.

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19

Pina, M. "Enteric coating of hard gelatin capsules. Part 2 — Lioavailability of formaldehyde treated capsules." International Journal of Pharmaceutics 148, no. 1 (1997): 73–84. http://dx.doi.org/10.1016/s0378-5173(96)04824-7.

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20

Dessy N Siahaan, Ririyen, Hakim Bangun, and Sumaiyah Sumaiyah. "IN VITRO AND IN VIVO EVALUATION OF FLOATING GASTRORETENTIVE DRUG DELIVERY SYSTEM OF CIMETIDINE USING HARD ALGINATE CAPSULES." Asian Journal of Pharmaceutical and Clinical Research 11, no. 6 (2018): 162. http://dx.doi.org/10.22159/ajpcr.2018.v11i6.24731.

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Objective: The objective of this study was to evaluate in vitro and in vivo of gastroretentive drug delivery system of cimetidine using hard alginate capsules.Methods: Drug release study was tested to various hard alginate capsules containing 200 mg cimetidine with paddle method dissolution apparatus in artificial gastric fluid pH 1.2. Concentrations of cimetidine were measured using ultraviolet spectrophotometer at 218.4 nm wavelength. The product that fulfilled the sustained release profile was evaluated for bioavailability using male rabbits at dose 9.3 mg/kg orally, and the antiulcer studies were evaluated by HCl-induced ulcer method at cimetidine dose 18 mg/kg once a day orally. Gastric lesions were evaluated by macroscopic and microscopic observations.Results: The results of drug release test showed that hard alginate capsule made from sodium alginate 500–600 cP gave sustained release profile of cimetidine for 12 h. In vivo bioavailability studies showed that cimetidine given with hard alginate capsules gave higher of Cmax, Tmax, and area under the curve of cimetidine compared to cimetidine that given with conventional hard gelatin capsules. The antiulcer studies showed that the healing effect of cimetidine that given with hard alginate capsules was faster than cimetidine given in suspension form. Cimetidine that given with hard alginate capsules macroscopically showed no gastric lesion and histopathologically also showed normal gastric mucosa of rats after 4 days treatment. However, cimetidine given in suspension form showed of 0.036±0.024 ulcer index and microscopically there was still erosion of gastric mucosa of rats after 4 days treatment.Conclusion: Floating gastroretentive of cimetidine using hard alginate capsules give a sustained release of cimetidine with better bioavailability and antiulcer effect of cimetidine.

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21

Vlachou, Marilena, Stefanos Kikionis, Angeliki Siamidi, et al. "Fabrication and Characterization of Electrospun Nanofibers for the Modified Release of the Chronobiotic Hormone Melatonin." Current Drug Delivery 16, no. 1 (2018): 79–85. http://dx.doi.org/10.2174/1567201815666180914095701.

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Objective: Aiming at the modified release of melatonin (MLT), electrospun-MLT loaded nanofibers, filled into hard gelatin and DRcapsTM capsules, were used as formulants. Methods: Cellulose acetate, polyvinylpyrrolidinone and hydroxypropylmethylcellusose (HPMC 2910) were used for the preparation of the fiber matrices through electrospinning. The in vitro modified release profile of MLT from the fabricated matrices in gastrointestinal-like fluids was studied. At pH 1.2, the formulations CA1, CA2, PV1, HP1, HP2 and the composite formulations CAPV1-CAPV5 in hard gelatin capsules exhibited fast MLT release. Results: In general, the same trend was observed at pH 6.8, with the exception of CAPV1 and CAPV2. These two composite formulations delivered 52.08% and 75.25% MLT, respectively at a slower pace (6 h) when encapsulated in DRcapsTM capsules. In all other cases, the release of MLT from DRcapsTM capsules filled with the MLT-loaded nanofibers reached 100% at 6h. Conclusion: These findings suggest that the MLT-loaded nanofibrous mats developed in this study exhibit a promising profile for treating sleep dysfunctions.

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Sadler, Brian M., Cynthia D. Hanson, Gregory E. Chittick, William T. Symonds, and Neil S. Roskell. "Safety and Pharmacokinetics of Amprenavir (141W94), a Human Immunodeficiency Virus (HIV) Type 1 Protease Inhibitor, following Oral Administration of Single Doses to HIV-Infected Adults." Antimicrobial Agents and Chemotherapy 43, no. 7 (1999): 1686–92. http://dx.doi.org/10.1128/aac.43.7.1686.

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ABSTRACT We conducted a double-blind, placebo-controlled, parallel, dose-escalation trial to evaluate the pharmacokinetics and safety of single, oral doses of amprenavir (141W94; formerly VX-478), a potent inhibitor of human immunodeficiency virus (HIV) type 1 protease, administered as hard gelatin capsules in 12 HIV-infected subjects. The doses of amprenavir evaluated were 150, 300, 600, 900, and 1,200 mg. Amprenavir was rapidly absorbed, with the time to maximum concentration occurring within 1 to 2 h after dosing. On the basis of power model analysis, the increase in the maximum concentration of amprenavir in plasma (C max) was less than dose proportional, and the increase in the area under the concentration-time curve from time zero to infinity (AUC0–∞) was greater than dose proportional; mean slopes (with 90% confidence intervals) were 1.25 (1.16 to 1.35) and 0.78 (0.78 to 0.86) for AUC0–∞ and C max, respectively. Amprenavir was eliminated slowly, with a terminal-phase half-life of 8 h. A second study was conducted to determine the bioavailability of the hard gelatin capsule relative to that of a subsequently developed soft gelatin capsule. The capsules were bioequivalent in terms of AUC0–∞ but not in terms ofC max; geometric-least-squares means ratios (with 90% confidence intervals) were 1.03 (0.92 to 1.14) and 1.25 (1.03 to 1.53) for AUC0–∞ andC max, respectively. Administration of soft gelatin capsules of amprenavir with a high-fat breakfast resulted in a 14% decrease in the mean AUC0–∞ (from 9.58 to 8.26 μg · h/ml), which is not likely to be clinically significant. The most common adverse events related to amprenavir were headache, nausea, and hypesthesia. Amprenavir appears to be safe and well tolerated over the dose range of 150 to 1200 mg. On the basis of the present single-dose studies, amprenavir is an HIV protease inhibitor with favorable absorption and clearance pharmacokinetics that are only minimally affected by administration with food.

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Mahardika, Micha, Fauzan Amin, Ika Agustia Umami, Boima Situmeang, and Agus Malik Ibrahim. "Synthesis and characterization of capsule shells non gelatin grass jelly leaves-seaweed as drug delivery system material." Jurnal Pendidikan Kimia 13, no. 1 (2021): 1–9. http://dx.doi.org/10.24114/jpkim.v13i1.24138.

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Drug delivery system is a system that describes the journey of a drug to its target location. The main component of the drug delivery system is gelatin. The leaves of grass jelly-seaweed are needed as a raw material for gelatin. The main component of gelling agents in grass jelly leaves and seaweed is a low-methoxy pectin polysaccharide. Pectin from previous study is used as a synthesis material for hard capsule shells with the addition of other ingredients, which are Na-CMC, sorbitol, and water. The characterization results of capsule shells with variations in the composition of grass jelly-seaweed leaves 0: 4, 1: 3, 2: 2, 3: 1, and 4: 0 (A, B, C, D and E) have a disolving time of 12 minutes 45 seconds; 15 minutes 53 seconds; 23 minutes 10 seconds; 15 minutes 35 seconds and 18 minutes 12 seconds. The swelling degree test each of 200%; 266,7%; 303.3%; 586.7% and 643.3%. Furthermore, the shells of grass jelly-seaweed leaf capsules were tested for their material performance in the cefadroxyl disolving test with variations in sampling time of 10, 20, and 30 minutes. Keywords: Cefadroxyl, Drug delivery system, Green grass jelly leaves, Non-gelatin capsules, Seaweed

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&NA;. "Saquinavir: soft and hard gelatin capsules have similar safety profile." Reactions Weekly &NA;, no. 841 (2001): 2. http://dx.doi.org/10.2165/00128415-200108410-00002.

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Weigert, Graziella Gonçalves, Aniéle Posser Ineu, and Patrícia Gomes. "Evaluation of hard gelatin capsules and hydroxypropyl methylcellulose containing ampicillin." Química Nova 35, no. 2 (2012): 286–90. http://dx.doi.org/10.1590/s0100-40422012000200010.

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Botzolakis, John E., and Larry L. Augsburger. "Disintegrating Agents in Hard Gelatin Capsules. Part II: Swelling Efficiency." Drug Development and Industrial Pharmacy 14, no. 9 (1988): 1235–48. http://dx.doi.org/10.3109/03639048809151931.

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Saim, Said, and Stephen T. Horhota. "Process for Overcoming Drug Retention in Hard Gelatin Inhalation Capsules." Drug Development and Industrial Pharmacy 28, no. 6 (2002): 641–54. http://dx.doi.org/10.1081/ddc-120003855.

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28

Салій, О. О., О. В. Лось, О. П. Баула, and В. Ю. Турчина. "Development of composition and evaluation of equivalence of diacerein hard gelatin capsules." Farmatsevtychnyi zhurnal, no. 6 (December 20, 2021): 62–72. http://dx.doi.org/10.32352/0367-3057.6.21.06.

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Diacerein is a new generation of symptomatic slow-acting agent for the treatment of osteoarthritis, when taken orally, it exhibits moderate anti-inflammatory and analgesic activity, slows down the decay of cartilage tissue and relieves pain and swelling, but its physicochemical properties it is practically insoluble in water, due to which only 35‒56% the drug reaches systemic circulation. Therefore, the search for approaches to increase the dissolution rate of a practically insoluble API using the formulation, type of excipients, degree of solubility and kinetics of the substance release from hard gelatin capsules should provide guaranteed drug efficacy. The aim of the work is to develop the composition of the drug in the form of hard gelatin capsules based on diacerein, to experimentally study the solubility of diacerein, and to evaluate the composition by studying the kinetics of dissolution of the drug. Determination of the pH-dependent solubility of diacerein was carried out in the conditions: the volume of the dissolution medium is 250 ml; dissolution temperature 37.0 ± 0.5 ºС. The highest recommended single dose of 50 mg was investigated. The development of the composition of the drug Diacerein, capsules, 50 mg was carried out with the use of various types of excipients and their modifications to achieve the proper technological properties in terms of fluidity (flowability) and a short disintegration time of the capsules for the release of the active substance. Comparative studies of the kinetics of dissolution were carried out by the in vitro method, the test «Dissolution» was studied a «Paddle apparatus» with a rotation speed of 75 rpm, a dissolution medium with a pH value of 1.2, 4.5 and 6.8, in a volume of 900 ml at a temperature of 37 ± 0.5 ºС. The reference drug was used «Artrodarin®», capsules of 50 mg, manufactured by TRB PHARMA S. A.,vArgentina. It was found that diacerein is practically insoluble in a buffer solution with a pH of 1.2, has a relatively low solubility in a buffer solution with a pH of 4.5, while the solubility of diacerein increases with an increase in the pH of the medium to 6.8. The optimal composition of capsules with diacerein using the wet granulation technology has been developed. The obtained data for bulk density and Carr's index indicate satisfactory flowability of the encapsulating mass. Comparative studies of the dissolution kinetics of the investigational medicinal product and the original drug «Artrodarin®», capsules of 50 mg were carried out. According to the calculations, all the obtained values of the similarity factor are in the range from 50 to 100 and indicate the similarity in buffer media with pH 1.2, 4.5 and 6.8. The developed composition of the preparation is equivalent in dissolution kinetics to the original medicine.

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Slipchenko, G. D. "Determination of the critical parameters of the technological process of obtaining solid dosage forms with dry extract and crushed roots and rootes of Scutellaria baicalensis." Farmatsevtychnyi zhurnal, no. 3 (July 1, 2019): 56–64. http://dx.doi.org/10.32352/0367-3057.3.19.07.

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An important condition for obtaining a high-quality drug is the determination of critical points and parameters of the production process, which is divided into several successive stages. The aim study of the critical parameters of the production of tablets and capsules with vegetable raw materials. For this purpose, validation studies of technological processes were carried out for tablets with dry extract of Scutellaria baicalensis and hard gelatin capsules with vegetable raw materials. The subject of our research was the technological process of obtaining tablets based on dry extract of the roots and rhizomes of Baikal skullcap and hard gelatin capsules based on crushed raw materials. We have identified critical process parameters for each stage. Validation tests were carried out for certain critical process parameters and acceptance criteria were calculated. Quality control of finished tablets based on dry extract of Baikal skullcap and finished hard gelatin capsules based on crushed roots and rhizomes of Baikal skullcap was performed according to the following indicators: appearance, identification, average weight, mass uniformity, disintegration, dissolution, abrasion, microbiological purity, quantitative determination . The obtained validation data of experimental-industrial series meet the acceptance criteria, and the developed technology is reproducible and promising for further validation. On the basis of the obtained results, it can be concluded that the established critical values of the parameters of the production processes and their conditions of carrying out allow for stable and reliable production of semi-finished and finished products that meet the quality standards in accordance with regulatory documents.

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Салій, О. О., Г. Г. Куришко, З. О. Огеренко та О. В. Гетало. "ПОРІВНЯЛЬНІ ДОСЛІДЖЕННЯ ПРОФІЛІВ ВИВІЛЬНЕННЯ ДОКСИЦИКЛІНУ ХІКЛАТУ З ТВЕРДИХ ЖЕЛАТИНОВИХ КАПСУЛ ПРИ ЗМІНІ ВИРОБНИКІВ ДІЮЧОЇ РЕЧОВИНИ". Bulletin of the Kyiv National University of Technologies and Design. Technical Science Series 146, № 3 (2021): 165–74. http://dx.doi.org/10.30857/1813-6796.2020.3.14.

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Comparative studies of the release profiles of doxycycline hyclate from hard gelatine capsules, developed with the active ingredient of alternative manufacturers. The object of the study is samples of the drug doxycycline hyclate in the form of hard gelatin capsules made from an API of an approved manufacturer "Kaifeng Pharmaceutical Group Co. Ltd", China and an alternative manufacturer "HebeiJiupeng Pharmaceutical Co., Ltd.", China. The study of the profiles of the release of the active substance from the drug was carried out using the "Paddle apparatus". The amount of the released substance was determined by the absorption spectrophotometry method.A drug was investigated in hard gelatin capsules of 100 mg based on the substance of doxycycline hyclate from two manufacturers "Kaifeng Pharmaceutical Group Co. Ltd", China, and "HebeiJiupeng Pharmaceutical Co., Ltd", China. It was found that according to the profile of impurities and the results of quality indicators, the substances of doxycycline hyclate from the studied manufacturers are alternative and interchangeable. To confirm the similarity of the dissolution profiles of doxycycline, 100 mg capsules were tested in accordance with the requirements of the State Pharmacopoeia Department, 2.9.3. Dissolution test, using solutions at three pH values: pH 1.0 (0.1 M HCl), pH 4.6 (acetate buffer) and pH 6.8 (phosphate physiological buffer). Comparative studies in vitro for two batches of the medicinal product established the similarity of the kinetics of the release of the active substance. The calculated values of the similarity factor are: f2 = 78.4 for a solution with pH = 1.2; f2 = 82.7 for a solution with pH = 4.6 and f2 = 75.8 for a solution with pH = 6.8. According to studies in three buffer solutions, the similarity coefficient is in the range from 50 to 100, which allows it to conclude that the studied API manufacturers can be used as alternatives for the production of the drug doxycycline hyclate in hard gelatin capsules of 100 mg. The relative standard deviation of the mean (RSD) release rate is less than 20% at the first control point and not more than 10% from the second to the last control point, indicating that the results are valid. It has been proven that the study of the dissolution profiles of solid dosage forms in vitro makes it possible to assess the risks of using APIs synthesized by various manufacturers. The obtained results of the experiment allow manufacturers of finished medicines to reasonably use alternative manufacturers of raw materials to ensure uninterrupted industrial production and meet market demand.

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31

Салій, О. О., Г. Г. Куришко, З. О. Огеренко та О. В. Гетало. "ПОРІВНЯЛЬНІ ДОСЛІДЖЕННЯ ПРОФІЛІВ ВИВІЛЬНЕННЯ ДОКСИЦИКЛІНУ ХІКЛАТУ З ТВЕРДИХ ЖЕЛАТИНОВИХ КАПСУЛ ПРИ ЗМІНІ ВИРОБНИКІВ ДІЮЧОЇ РЕЧОВИНИ". Bulletin of the Kyiv National University of Technologies and Design. Technical Science Series 146, № 3 (2021): 165–74. http://dx.doi.org/10.30857/1813-6796.2020.3.14.

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Comparative studies of the release profiles of doxycycline hyclate from hard gelatine capsules, developed with the active ingredient of alternative manufacturers. The object of the study is samples of the drug doxycycline hyclate in the form of hard gelatin capsules made from an API of an approved manufacturer "Kaifeng Pharmaceutical Group Co. Ltd", China and an alternative manufacturer "HebeiJiupeng Pharmaceutical Co., Ltd.", China. The study of the profiles of the release of the active substance from the drug was carried out using the "Paddle apparatus". The amount of the released substance was determined by the absorption spectrophotometry method.A drug was investigated in hard gelatin capsules of 100 mg based on the substance of doxycycline hyclate from two manufacturers "Kaifeng Pharmaceutical Group Co. Ltd", China, and "HebeiJiupeng Pharmaceutical Co., Ltd", China. It was found that according to the profile of impurities and the results of quality indicators, the substances of doxycycline hyclate from the studied manufacturers are alternative and interchangeable. To confirm the similarity of the dissolution profiles of doxycycline, 100 mg capsules were tested in accordance with the requirements of the State Pharmacopoeia Department, 2.9.3. Dissolution test, using solutions at three pH values: pH 1.0 (0.1 M HCl), pH 4.6 (acetate buffer) and pH 6.8 (phosphate physiological buffer). Comparative studies in vitro for two batches of the medicinal product established the similarity of the kinetics of the release of the active substance. The calculated values of the similarity factor are: f2 = 78.4 for a solution with pH = 1.2; f2 = 82.7 for a solution with pH = 4.6 and f2 = 75.8 for a solution with pH = 6.8. According to studies in three buffer solutions, the similarity coefficient is in the range from 50 to 100, which allows it to conclude that the studied API manufacturers can be used as alternatives for the production of the drug doxycycline hyclate in hard gelatin capsules of 100 mg. The relative standard deviation of the mean (RSD) release rate is less than 20% at the first control point and not more than 10% from the second to the last control point, indicating that the results are valid. It has been proven that the study of the dissolution profiles of solid dosage forms in vitro makes it possible to assess the risks of using APIs synthesized by various manufacturers. The obtained results of the experiment allow manufacturers of finished medicines to reasonably use alternative manufacturers of raw materials to ensure uninterrupted industrial production and meet market demand.

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32

Gammel, I. V., and S. А. Gorbunova. "The study of the range of drugs in hard gelatin capsules." Medical almanac, no. 1 (2018): 121–25. http://dx.doi.org/10.21145/2499-9954-2018-1-121-125.

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33

Berardi, Alberto, Lorina Bisharat, Marco Cespi, et al. "Controlled release properties of zein powder filled into hard gelatin capsules." Powder Technology 320 (October 2017): 703–13. http://dx.doi.org/10.1016/j.powtec.2017.07.093.

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34

Hashem, Fahima M., Ahmad M. A. Massoud, Abdullah M. Melokheya, Hazem Emad, Kamal Abd El-Fattah Badr, and Mohamed Dawoud. "Formulation and Clinical Efficacy of Myrrh Extract in Hard Gelatin Capsules." Journal of Biologically Active Products from Nature 3, no. 1 (2013): 72–86. http://dx.doi.org/10.1080/22311866.2013.782763.

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35

Howard, J. R., and P. L. Gould. "Drug Release from Thermosetting Fatty Vehicles Filled into Hard Gelatin Capsules." Drug Development and Industrial Pharmacy 13, no. 6 (1987): 1031–45. http://dx.doi.org/10.3109/03639048709068368.

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36

Botzolakis, John E., and Larry L. Augsburger. "Disintegrating Agents in Hard Gelatin Capsules. Part I: Mechanism of Action." Drug Development and Industrial Pharmacy 14, no. 1 (1988): 29–41. http://dx.doi.org/10.3109/03639048809151958.

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37

Walters, P. A., G. Rowley, J. T. Pearson, and C. J. Taylor. "Formulation and physical properties of thixotropic gels for hard gelatin capsules." Drug Development and Industrial Pharmacy 18, no. 15 (1992): 1613–31. http://dx.doi.org/10.3109/03639049209040890.

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38

Barham, Ahmad S., Frederic Tewes, and Anne Marie Healy. "Moisture diffusion and permeability characteristics of hydroxypropylmethylcellulose and hard gelatin capsules." International Journal of Pharmaceutics 478, no. 2 (2015): 796–803. http://dx.doi.org/10.1016/j.ijpharm.2014.12.029.

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39

Omar, Samia Mohamed, Rania Safaa Abdel-Rashid, Mohamed Kamal AlAssaly, and Tamer M. Sakr. "Adaptation of hard gelatin capsules for oral delivery of aqueous radiopharmaceuticals." DARU Journal of Pharmaceutical Sciences 27, no. 1 (2019): 295–305. http://dx.doi.org/10.1007/s40199-019-00275-2.

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40

Cardiello, Peter G., Tarkika Monhaphol, Apicha Mahanontharit, et al. "Pharmacokinetics of Once-Daily Saquinavir Hard-Gelatin Capsules and Saquinavir Soft-Gelatin Capsules Boosted With Ritonavir in HIV-1–Infected Subjects." JAIDS Journal of Acquired Immune Deficiency Syndromes 32, no. 4 (2003): 375–79. http://dx.doi.org/10.1097/00126334-200304010-00005.

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41

Dewan, Irin, Ananta Saha, SM Ashraful Islam, Mahjabeen Gazi, Tasnuva Amin, and Sayeeda Fahmee Chowdhury. "Study and Evaluation of Release Kinetics of Tramadol HCl from Lipid Based Sustained Release Capsules by Melt Matrix." Dhaka University Journal of Pharmaceutical Sciences 11, no. 2 (2013): 137–45. http://dx.doi.org/10.3329/dujps.v11i2.14572.

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The aim of our study was to improve the dissolution of Tramadol hydrochloride (TH) via its semisolid filled lipid based capsules. Sustained release formulation is designed to achieve a prolonged therapeutic effect by continuously releasing medication over an extended period of time after administration of single dose. Semisolid matrixes of TH were prepared by melt-matrix method and were filled in hard gelatin capsule shell (size 0). In this experiment, a mixture of Glycerol monostearate (GMS) and lipid materials like different lipophilic oils and surfactants were used to improve the matrix integrity and drug release. The effects of different oils like Arachis oil, Soyabean oil, castor oil, neobee oil and olive oil and different surfactants such as Span 80, Tween 80, PEG 400, Chremophore RH 40, Cremophor EL were analyzed by formulating at various ratios. The matrices were subjected to the paddle dissolution method using 900 ml of phosphate buffer (pH 6.8). The dissolution test was performed at 100 RPM and the temperature was set at 37 ± 0.50C. The amount of drug was measured from the absorbance with a UV spectrophotometer at 270 nm. The release of drug was plotted in zero order-, 1st order- and Higuchi-release patterns. The correlation coefficients values of the trend lines of the graphs revealed that the formulations best fit in Higuchian release pattern. So it can be said that the pharmaceutical quality of Tramadol HCl capsules can be improved by using a semisolid lipophilic matrix filled in hard gelatin capsules. DOI: http://dx.doi.org/10.3329/dujps.v11i2.14572 Dhaka Univ. J. Pharm. Sci. 11(2): 137-145, 2012 (December)

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42

Naik, S. B. Thirumalesh, M. Purushothaman, and K. B. Chandrasekhar. "Fabrication and Evaluation of Mini Tablet Filled Capsules to Treat Transient Ischemic Attack." Asian Journal of Chemistry 33, no. 1 (2020): 89–96. http://dx.doi.org/10.14233/ajchem.2021.22929.

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In this work, mini tablets filled hard gelatin capsules were fabricated for a fixed-dose therapy for transient ischemic attack (TIA). Clopidogrel besylate (CB)-75 mg and acetyl salicylic acid (ASA)-75 mg were utilized in this work. Among the mini-tablets (MTs) clopidogrel besylate, was uncoated conventional mini-tablets, whereas acetyl salicylic acid was enteric-coated. Acetyl salicylic acid gastric irritation was overcome by using Plantago ovata seed mucilage as a binder in all mini-tablets. Both types of mini-tablets were filled in hard gelatin capsules. Clopidogrel besylate and acetyl salicylic acid compatibility with excipients used were evaluated, all the mini-tablets were judged for post-compression constraints. The prepared mini-tablets confirmed no interaction by FTIR and DSC studies. All the mini-tablets passed the physico-chemical constraints. Clopidogrel besylate was released from the dosage form within 45 min, whereas enteric-coated acetyl salicylic acid mini-tablets resist to release in an acidic environment and released within 45 min in an alkaline buffer. Even the filled capsules were also passed all the parameters evaluated. The study concludes that by using P. ovata as a binder in making tablets will resolve the issues related to gastric irritation.

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43

Kurowski, M., T. Sternfeld, A. Sawyer, A. Hill, and C. Mocklinghoff. "Pharmacokinetic and tolerability profile of twice-daily saquinavir hard gelatin capsules and saquinavir soft gelatin capsules boosted with ritonavir in healthy volunteers." HIV Medicine 4, no. 2 (2003): 94–100. http://dx.doi.org/10.1046/j.1468-1293.2003.00143.x.

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44

Al-Tabakha, Moawia M., Adi Issam Arida, Khairi M. S. Fahelelbom, et al. "Influence of capsule shell composition on the performance indicators of hypromellose capsule in comparison to hard gelatin capsules." Drug Development and Industrial Pharmacy 41, no. 10 (2015): 1726–37. http://dx.doi.org/10.3109/03639045.2014.1002409.

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45

Omar, Samia, Rania AbdelRashid, Mohamed Assaly, and Tamer Sakr. "Adaptation of Hard Gelatin Capsules for Aqueous Solution Delivery Using Gamma Radiation." Journal of Advanced Pharmacy Research 2, no. 1 (2018): 258–65. http://dx.doi.org/10.21608/aprh.2018.4882.

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46

Delord, Jean-Pierre, Jaafar Bennouna, Loïc Mourey, Joël Bougaret, Maud Brandely-Talbot, and Pierre Ferré. "Vinflunine Oral Pharmacokinetics and Absolute Bioavailability of Soft and Hard Gelatin Capsules." Clinical Pharmacokinetics 51, no. 6 (2012): 357–64. http://dx.doi.org/10.2165/11599300-000000000-00000.

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47

Erlich, LuAnn, Danny Yu, David A. Pallister, et al. "Relative bioavailability of danazol in dogs from liquid-filled hard gelatin capsules." International Journal of Pharmaceutics 179, no. 1 (1999): 49–53. http://dx.doi.org/10.1016/s0378-5173(98)00386-x.

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48

Naidoo, N. T. "Formulation and Processing Factors Affecting the Disintegration of Hard-Shell Gelatin Capsules." Drug Development and Industrial Pharmacy 15, no. 9 (1989): 1329–39. http://dx.doi.org/10.3109/03639048909062748.

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49

SMAL, J., O. HAAPALA, M. MARVOLA, S. KUUSELA, and I. HAPPONEN. "Prolonged-release hard gelatin capsules of furosemide for the treatment of dogs." Journal of Veterinary Pharmacology and Therapeutics 18, no. 1 (1995): 17–23. http://dx.doi.org/10.1111/j.1365-2885.1995.tb00545.x.

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50

Yang, Ning, Huanfei Chen, Zhu Jin, et al. "Moisture sorption and desorption properties of gelatin, HPMC and pullulan hard capsules." International Journal of Biological Macromolecules 159 (September 2020): 659–66. http://dx.doi.org/10.1016/j.ijbiomac.2020.05.110.

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