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1

Tamader, Elghnimi1* Wadiaa Benamer2 Rehab Walli3 Mawadda Benshaban1 Marwa Benashour1. "Comparative in-vitro Evaluation of Some Desloratadine Tablets Marketed in Tripoli Libya." Alq J Med App Sci 5, no. 2 (2022): 556–64. https://doi.org/10.5281/zenodo.7391018.

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<strong>Background and aims.</strong> Desloratadine is a tricyclic, potent, rapidly effective, long acting, non-sedative antihistamine, which has a selective and peripheral H1 receptor antagonist action, used to treat the allergies. The availability of several brands of Desloratadine tablets in Libyan pharmacies today places health practitioners and a pharmacist in a problem of drug substitution in case of a particular brand is not available. The aim of the present study was the evaluation and comparison of pharmaceutical equivalence of five different Desloratadine tablets 5 mg, which are commercially available in the private pharmacies in Tripoli city with different price ranges, produced by various pharmaceutical companies. <strong>Methods</strong>. The pharmaceutical evaluation of five brands of Desloratadine tablets were done using official and unofficial quality control tests prescribed in different Pharmacopoeia including uniformity of weight, thickness, hardness, disintegration time, drug content as well as dissolution rate and identification test. Acceptable external features as well as uniformity in diameter and thickness were revealed for all the tablets. <strong>Results</strong>. The entire selected brands complied with the official specifications for uniformity of weight, hardness and disintegration, more than 80% of their drug dissolved in the medium within 60 minutes. <strong>Conclusion</strong>. It can be concluded that all the brands could be regarded as bioequivalent and therefore can be interchanged in the clinical practice; this sort of study is good indicator for the evaluation of the idealness of commercial products and showed the importance of post marketing investigation for the drugs imported and distributed in Libya.
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2

Rummana Amin, Sabana,, Brishti, Shadia Afrin, Hossain Nazmul, and Rahman, Mohammed Shafikur. "In-Vitro Evaluation of Different Brands of Desloratadine Tablets Available in Bangladeshi market." DIU Journal of Health and Life Sciences 3, no. 1 & 2 (2016): 05–11. http://dx.doi.org/10.36481/diuhls.v03i1-2.9zdn3e56.

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Desloratadine, a long acting antihistamine with high selectivity for peripheral histamine H1- receptors has a rapid onset of action and a duration of action of 24-hours. Due to difference in the formulation process for different brands different physicochemical properties may vary which ultimately leads to change in the efficacy and duration of action of the drug when given orally. The aim of this study was to analyze the quality and stability of desloratadine 5mg tablet by evaluating various in-vitro parameters. For this purpose, five different brands from different pharmaceutical companies of Bangladesh were collected. The quality control parameters including weight variation, hardness, friability, disintegration test and dissolution test were performed to get a comparison between these marketed products. As desloratadine is an INN (International Nonproprietary Names) drug, it has no specific dissolution method in USP (United State Pharmacopoeia) or BP (British Pharmacopoeia). So, a dissolution method listed by USFDA (United States Food &amp; Drug Administration) was followed. Various results were obtained from the test and compared with the specifications. Minimum disintegration time was found 31 sec. Best Dissolution was shown 97.67% after 45 minutes. From the study, it can be concluded that the most brands of desloratadine tablets of the local brands have the desired and optimum therapeutic efficacy.
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Sabana, Rummana Amin, Shadia Afrin Brishti, Nazmul Hossain, and Mohammed Shafikur Rahman. "In-Vitro Evaluation of Different Brands of Desloratadine Tablets Available in Bangladeshi market." DIU Journal of Allied Health Sciences 3, no. 1 & 2 (2016): 05–11. https://doi.org/10.36481/diujahs.v03i1-2.9zdn3e56.

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Desloratadine, a long acting antihistamine with high selectivity for peripheral histamine H1- receptors has a rapid onset of action and a duration of action of 24-hours. Due to difference in the formulation process for different brands different physicochemical properties may vary which ultimately leads to change in the efficacy and duration of action of the drug when given orally. The aim of this study was to analyze the quality and stability of desloratadine 5mg tablet by evaluating various in-vitro parameters. For this purpose, five different brands from different pharmaceutical companies of Bangladesh were collected. The quality control parameters including weight variation, hardness, friability, disintegration test and dissolution test were performed to get a comparison between these marketed products. As desloratadine is an INN (International Nonproprietary Names) drug, it has no specific dissolution method in USP (United State Pharmacopoeia) or BP (British Pharmacopoeia). So, a dissolution method listed by USFDA (United States Food &amp; Drug Administration) was followed. Various results were obtained from the test and compared with the specifications. Minimum disintegration time was found 31 sec. Best Dissolution was shown 97.67% after 45 minutes. From the study, it can be concluded that the most brands of desloratadine tablets of the local brands have the desired and optimum therapeutic efficacy.
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4

Rummana, Amin Sabana, Afrin Brishti Shadia, Hossain Nazmul, and Shafikur Rahman Mohammed. "In-Vitro Evaluation of Different Brands of Desloratadine Tablets Available in Bangladeshi Market." Journal of Allied Health and Life Sciences 3, no. 1&2 (2016): 5–11. https://doi.org/10.5281/zenodo.11001391.

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Abstract: Desloratadine, a long acting antihistamine with high selectivity for peripheral histamine H1- receptors has a rapid onset of action and a duration of action of 24-hours. Due to difference in the formulation process for different brands different physicochemical properties may vary which ultimately leads to change in the efficacy and duration of action of the drug when given orally. The aim of this study was to analyze the quality and stability of desloratadine 5mg tablet by evaluating various in-vitro parameters. For this purpose, five different brands from different pharmaceutical companies of Bangladesh were collected. The quality control parameters including weight variation, hardness, friability, disintegration test and dissolution test were performed to get a comparison between these marketed products. As desloratadine is an INN (International Nonproprietary Names) drug, it has no specific dissolution method in USP (United State Pharmacopoeia) or BP (British Pharmacopoeia). So, a dissolution method listed by USFDA (United States Food &amp; Drug Administration) was followed. Various results were obtained from the test and compared with the specifications. Minimum disintegration time was found 31 sec. Best Dissolution was shown 97.67% after 45 minutes. From the study, it can be concluded that the most brands of desloratadine tablets of the local brands have the desired and optimum therapeutic efficacy.
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5

Berginc, Katja, Nadica Sibinovska, Simon Žakelj, Jurij Trontelj, and Igor Legen. "Biopharmaceutical classification of desloratadine – not all drugs are classified the easy way." Acta Pharmaceutica 70, no. 2 (2020): 131–44. http://dx.doi.org/10.2478/acph-2020-0006.

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AbstractThe biopharmaceutical classification of drugs was designed as a basis for bio-waivers – a mechanism with the double ethical benefit of delivering new drug formulations to the market with less human testing and lower cost. However, many drugs defy simple classification because in vitro permeability and stability assessment can be challenging as shown in this study for desloratadine. Literature shows that desloratadine is highly soluble, while data on luminal stability and permeability are circumstantial. Combined with borderline bioavailability and not really known fraction of absorbed dose, desloratadine was found to be a good example for showing the innovative in vitro approaches necessary to unambiguously classify desloratadine according to Biopharmaceutical Classification System (BCS) guideline. Presented study undoubtedly confirmed that desloratadine solubility is high and dissolution is very rapid for immediate release reference tablets. We have demonstrated deslorata-dine stability under legally required conditions and also in more physiologically relevant media. High in vitro desloratadine permeability was confirmed using Caco-2 and Parallel Artificial Membrane Permeability Assay (PAMPA). Well-established in vitro model with rat intestinal tissue could not be used due to reasons elaborated in this paper.
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6

Abbas, Muhammad, Musharraf Abbas, Fatima Tariq, Rabiya Yasin, and Muhammad Nabeel. "Formulation and evaluation of chewable tablets of Desloratadine prepared by aqueous and non-aqueous techniques." Journal of Drug Delivery and Therapeutics 10, no. 1 (2020): 5–10. http://dx.doi.org/10.22270/jddt.v10i1.3796.

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In the modern era, chewable tablets are preferred over conventional dosage forms by pediatric, geriatric and bedridden patients due to difficulty in swallowing, lesser amount of water for swallowing medications as well as unable to tolerate the bitter taste of certain drugs. Chewable tablets of Desloratadine (DS) were formulated by aqueous and non-aqueous granulation method using water paste and Isopropyl alcohol (IPA) as a wetting agents respectively. Desloratadine is used to treat the symptoms of allergy such as sneezing, watery eyes. In the recent research, we have formulated eight trials by various concentrations of excipients. For instance; lactose, talcum, magnesium stearate, blue color, flavor, aspartame, mannitol, avicel 101 and polyvenylpyrollidine (PVP). Pre-compression and post compression parameters (thickness, hardness, friability weight variation and drug content) of the formulations were evaluated. B3 was our optimum dosage form because its Hausner’s ratio, compressibility index, bulk density, tap density, angle of repose have optimum values i.e. 1.01, 5.1%, 0.66(g/cc), 0.69(g/cc), 26.1º respectively and post-compression i.e. thickness, hardness, friability weight variation and drug content have values, 2.9mm, 3.9(kg/cm²), 0.6%, 99.5% respectively. Tablets prepared by wet granulation technique showed reasonable release profile i.e. 100% within the required time i.e. 2 hours. Moreover, organoleptic evaluation of all formulations were performed.&#x0D; Keywords: Desloratadine, chewable, magnesium stearate, aspartame, compressibility, granulation.
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7

Leontiev, Dmytro, Vasyl Petrus, Natalia Volovyk, and Oleksandr Gryzodub. "VALIDATION OF THE SPECTROPHOTOMETRIC PROCEDURE FOR DESLORATADINE ASSAY IN TABLETS APPLYING THE UNCERTAINTY CONCEPT OF THE STATE PHARMACOPOEIA OF UKRAINE." EUREKA: Health Sciences, no. 6 (November 29, 2020): 74–87. http://dx.doi.org/10.21303/2504-5679.2020.001527.

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Aim. This work aimed to validate an assay procedure for desloratadine tablets by direct spectrophotometric method.&#x0D; Materials and methods. A pilot-scale batch of the pharmaceutical preparation Alerdez, film-coated tablets containing 5 mg of desloratadine, manufactured by PJSC SIC “Borshchahivskiy CPP”, Ukraine, was used as an object of the study. A UV-Vis spectrophotometer Lambda 25 (Perkin Elmer), analytical balance Mettler Toledo XP 205DR, and class A volumetric apparatus were used in the study. Validation of the procedure was performed following the metrological approach of the State Pharmacopoeia of Ukraine (SPhU), whose requirements for the target uncertainty and bias, which rest on the risk assessment of making incorrect decisions on compliance (a confidence level of 95 %), were translated into criteria for all validation characteristics recommended by ICH. All calculations were made in normalised coordinates. The linearity, accuracy and precision (repeatability) were studied in a single experiment using nine different concentrations that uniformly covered the range of ±30 % from the nominal concentration of desloratadine. For validation of the procedure, an SPhU reference standard of desloratadine was used.&#x0D; Results. The experiment design and validation characteristics being tested were in full compliance with ICH Q2(R1) recommendations. All performance characteristics conformed to the criteria recommended by the SPhU. Requirements for the target uncertainty (1.6 %) and bias for any systematic source of variation (≤0.51 %, negligible in relation to 1.6 %) were established. The analytical procedure was specific – the absorbance from the placebo solution was insignificant (A %=0.36). The procedure met the requirements for linearity, accuracy, and precision at the repeatability level. The residual standard deviation s0 was 0.34 (≤ 0.84); correlation index Rc was 0.9998 (≥0.9991); intercept а was 0.045 (less than its confidence interval ∆a=1.14). The confidence interval for recovery ∆Z, which was used as a precision estimate, was 0.55 % (less than the target uncertainty). The mean recovery, which was used as an accuracy estimate, statistically insignificantly deviated from 100% (|Zmean ‑ 100| = 0.022 %).&#x0D; The confidence interval for the intermediate precision ∆intra was 0.33 % (less than the target uncertainty). The developed analytical procedure was found to be robust.&#x0D; Conclusions. A spectrophotometric procedure suitable for the assay of desloratadine in film-coated tablets Alerdez with content limits of ±5 % was validated by the SPhU approach.
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8

Çğalar, Sena, and Aysel Öztun. "A Sensitive Spectrophotometric Method for the Determination of Desloratadine in Tablets." Journal of AOAC INTERNATIONAL 90, no. 2 (2007): 372–75. http://dx.doi.org/10.1093/jaoac/90.2.372.

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Abstract A simple, rapid, and sensitive visible spectrophotometric method was developed, for the first time, for analysis of desloratadine (DE) in tablets. The method is based on the deep-blue colored TCNQ- radical anion formed by interaction of the drug (n-donor) with 7,7,8,8-tetracyanoquinodimethane (TCNQ, π-acceptor) in acetonitrile at ambient temperature. Optimum conditions for the reaction were investigated, absorbances were read at 843 nm, and the linearity range for concentrations of DE was found to be 1.5-13 μg/mL. The reaction product remains stable up to 8 h when kept at room temperature in the dark. The developed method was validated and successfully applied to the determination of DE in tablets. The tablets were also analyzed with a column liquid chromatography method reported in literature. The results from both methods were statistically compared by t- and F-tests. No significant difference was found for the means and standard deviations at 95% confidence level. Accuracy was examined through recovery studies. Being very simple and reliable, the method can be recommended for routine quality control analysis of DE in tablets.
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9

Dmytro, Leontiev, Petrus Vasyl, Volovyk Natalia, and Gryzodub Oleksandr. "VALIDATION OF THE SPECTROPHOTOMETRIC PROCEDURE FOR DESLORATADINE ASSAY IN TABLETS APPLYING THE UNCERTAINTY CONCEPT OF THE STATE PHARMACOPOEIA OF UKRAINE." EUREKA: Health Sciences, no. 6 (November 30, 2020): 74–87. https://doi.org/10.21303/2504-5679.2020.001527.

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<strong>Aim</strong>. This work aimed to validate an assay procedure for desloratadine tablets by direct spectrophotometric method. <strong>Materials and methods</strong>. A pilot-scale batch of the pharmaceutical preparation&nbsp;<em>Alerdez</em>, film-coated tablets containing 5 mg of desloratadine, manufactured by PJSC SIC &ldquo;Borshchahivskiy CPP&rdquo;, Ukraine, was used as an object of the study. A UV-Vis spectrophotometer Lambda 25 (Perkin Elmer), analytical balance Mettler Toledo XP 205DR, and class A volumetric apparatus were used in the study. Validation of the procedure was performed following the metrological approach of the State Pharmacopoeia of Ukraine (SPhU), whose requirements for the target uncertainty and bias, which rest on the risk assessment of making incorrect decisions on compliance (a confidence level of 95 %), were translated into criteria for all validation characteristics recommended by ICH. All calculations were made in normalised coordinates. The linearity, accuracy and precision (repeatability) were studied in a single experiment using nine different concentrations that uniformly covered the range of &plusmn;30 % from the nominal concentration of desloratadine. For validation of the procedure, an SPhU reference standard of desloratadine was used. <strong>Results</strong>. The experiment design and validation characteristics being tested were in full compliance with ICH Q2(R1) recommendations. All performance characteristics conformed to the criteria recommended by the SPhU. Requirements for the target uncertainty (1.6 %) and bias for any systematic source of variation (&le;0.51 %, negligible in relation to 1.6 %) were established. The analytical procedure was specific &ndash; the absorbance from the placebo solution was insignificant (A %=0.36). The procedure met the requirements for linearity, accuracy, and precision at the repeatability level. The residual standard deviation<em>&nbsp;s<sub>0</sub></em>&nbsp;was 0.34 (&le; 0.84); correlation index&nbsp;<em>R<sub>c</sub></em>&nbsp;was 0.9998 (&ge;0.9991); intercept&nbsp;<em>а</em>&nbsp;was 0.045 (less than its confidence interval ∆<em><sub>a</sub></em>=1.14). The confidence interval for recovery&nbsp;<em>∆<sub>Z</sub></em>, which was used as a precision estimate, was 0.55 % (less than the target uncertainty). The mean recovery, which was used as an accuracy estimate, statistically insignificantly deviated from 100% (|Z<sub>mean</sub>&nbsp;‑&nbsp;100| = 0.022 %). &nbsp;The confidence interval for the intermediate precision&nbsp;<em>∆<sub>intra</sub></em>was 0.33 % (less than the target uncertainty). The developed analytical procedure was found to be robust. <strong>Conclusions</strong>. A spectrophotometric procedure suitable for the assay of desloratadine in film-coated tablets&nbsp;<em>Alerdez</em>&nbsp;with content limits of &plusmn;5 % was validated by the SPhU approach.
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10

Dmytro, Leontiev, Petrus Vasyl, Volovyk Natalia, and Gryzodub Oleksandr. "A study of the influence of the test sample inhomogeneity on variability in assay results of desloratadine in film-coated tablets." ScienceRise: Pharmaceutical Science, no. 5(27) (October 30, 2020): 43–51. https://doi.org/10.15587/2519-4852.2020.215287.

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<strong>Aim</strong>. The work aimed at metrological evaluation and management of the risk of inconsistency in the results of desloratadine assay in film-coated tablets. <strong>Materials and methods</strong>. A pilot-scale batch of the pharmaceutical preparation Alerdez served as a study object. Spectrophotometric readings were performed on a UV-Vis spectrophotometer Lambda 25 at 282 nm. An analytical balance Mettler Toledo, pH-meter Metrohm, Class A volumetric pipettes and flasks were used for analysis. The test sample was prepared by manual tablet grinding. <strong>Results and discussion</strong>. A trend of obtaining inconsistent assay results with a systematic shift towards an increase while taking test portions in sequence was observed. This may inform a test sample inhomogeneity, which may be reduced by increasing a test portion mass. An experiment design to study the impact of the test portion mass on the variability in assay results was laid down. A prognosis for the minimum test portion mass contributing to the mitigation of the risk of the test sample inhomogeneity was scientifically justified and experimentally verified. Acceptance criteria for the assessment of the test sample homogeneity by assay results were established based on the principle of insignificance and recommendations of the State Pharmacopoeia of Ukraine to the target measurement uncertainty. A procedure for desloratadine assay intended to be used for the method transfer and routine analysis, as well as acceptance criteria for assay results, was developed. Their feasibility was experimentally proved during method transfer. The greater difference between the values obtained in the receiving unit compared to those collected in the sending unit was observed, yet the results met the acceptance criteria. <strong>Conclusions</strong>. This paper provides comprehensive solutions that allow for minimizing the risk of variability in desloratadine assay results. The risk of aberrant assay results could be mitigated by using a test portion equivalent to the weight of four tablets (approx. 420 mg)
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11

Kutekhova, G. V., E. O. Zhuravleva, M. A. Darmostukova, et al. "Signal Messages in Pediatric Practice." Safety and Risk of Pharmacotherapy 6, no. 4 (2018): 180–86. http://dx.doi.org/10.30895/2312-7821-2018-6-4-180-186.

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Abstract. Detection and analysis of drug safety signals in children is a mandatory part of pharmacovigilance. The criteria for evaluating signals of adverse effects were considered. Spontaneous reports databases as a source for detecting signaling information about adverse reactions, including in children were used. More than 17.5 million cases of adverse reactions identified in WHO global database of individual case safety reports — VigiBase which was detected since 1968 in 120 countries — members of the WHO Drug Treatment Control Program. Of these, 1.5 million cases of adverse reactions occur in childhood. Objective: search and analysis for signal information in the post-marketing period of the use of drugs in children to increase the safety of pharmacotherapy in pediatric practice. Results: а causal relationship between desloratadine and weight gain was detected. Desloratadine is an active metabolite of loratadine so the researchers have considered reports on desloratadine and also on loratadine. In VigiBase there are reports of weight gain when taking desloratadine (44 messages) and loratadine (115 messages) in 2016. Among them, 22 reports on weight gain in children from 2 to 11 years. The Pharmacovigilance Risk Assessment Committee of the European Medical Agency (PRAC EMA) recommended marketing authorization holders to add an information about weight gain in children in prescribing information of drugs which contains desloratadine and loratadine. In September 2017, the Committee on Drugs for Human Use, following a review and analysis of VigiBase, approved the recommendations of PRAC EMA. Appropriate changes were made to the instructions for medical use for loratadine tablets. Conclusions. These results confirm the importance of long post-marketing studies, the results of which will provide significant assistance in improving the safety of pharmacotherapy in children.
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Banfield, Christopher, Samir Gupta, Melton Affrime, and Vijay Batra. "Pharmacokinetic equivalence of pediatric dosages of desloratadine syrup in children and standard 5-mg desloratadine tablets in adults." Journal of Allergy and Clinical Immunology 109, no. 1 (2002): S103. http://dx.doi.org/10.1016/s0091-6749(02)81414-2.

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13

Sumarlik, Endang, Hoshi Tampubolon, Mochammad Yuwono, and Gunawan Indrayanto. "Densitometric determination of desloratadine in tablets, and validation of the method." Journal of Planar Chromatography – Modern TLC 18, no. 101 (2005): 19–22. http://dx.doi.org/10.1556/jpc.18.2005.1.3.

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14

Falcão, Brunna Ricci, Letícia de Melo Teixeira, Francine Zachow Philippsen, and Tiago Rafael Sausen. "Development and Validation of a Dissolution Method for Desloratadine Coated Tablets." UK Journal of Pharmaceutical Biosciences 5, no. 1 (2017): 12. http://dx.doi.org/10.20510/ukjpb/5/i1/147020.

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Takano, Diogo Eiji Nakao, Pedro Rodrigo de Souza Reis, Anil Kumar Singh, and Felipe Rebello Lourenço. "Estimation of uncertainty for measuring desloratadine in tablets formulation using UV spectrophotometry." Measurement 101 (April 2017): 40–44. http://dx.doi.org/10.1016/j.measurement.2017.01.018.

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Mamatha, J., and N. Devanna. "RP-HPLC-PDA Method for Simultaneous Quantification of Montelukast, Acebrophylline and Desloratadine Tablets." Asian Journal of Chemistry 30, no. 6 (2018): 1383–86. http://dx.doi.org/10.14233/ajchem.2018.21269.

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Natalia, Volovyk, Leontiev Dmytro, and Petrus Vasyl. "Development of an advanced strategy on the assay method transfer." ScienceRise: Pharmaceutical Science, no. 6(28) (December 30, 2020): 56–67. https://doi.org/10.15587/2519-4852.2020.221721.

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<strong>Aim</strong>. The paper intends to frame and pilot the optimised science-based principles of the assay transfer. <strong>Materials and methods</strong>. The research was performed on desloratadine film-coated tablets, using an analytical balance Mettler Toledo XP 205DR and Class A volumetric glassware. Absorbance readings were measured on a UV-Vis spectrophotometer Lambda 25. <strong>Results and discussion</strong>. The concept of method transfer that complements the conventional approach to validation with the lifecycle initiative and the metrological base of the State Pharmacopoeia of Ukraine was substantiated, following which the transfer of the spectrophotometric procedure for desloratadine assay was conducted. For the batch intended for the transfer, the budget of analytical and technological variability was balanced. The deviation of a single assay result from the grand mean was used as the criterion for accuracy in the transfer. The requirement for the one-sided confidence interval for assay result runs not to exceed the target uncertainty of the procedure was used as the criterion for precision. The control strategy requirements for variability sources and the analytical target profile requirements for precision and accuracy were met in the receiving unit. <strong>Conclusion</strong>. The paper discusses the premise and advocates an alternative approach to the method transfer. Precision is proposed not to study during the transfer (in the short-term experiment) but assess from the stability data (in the long-term experiment). Compliance with the normal analytical practice (the maximum permissible variability attributed to analysts and analytical instruments) allows narrowing down the transfer design to the confirmation in the minimal experiment that the amplitude of variability sources lies within the predefined range
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Liu, Lihe, Meiling Qi, Peng Wang, and Haozhi Li. "High-performance liquid chromatographic method for the bioequivalence evaluation of desloratadine fumarate tablets in dogs." Journal of Pharmaceutical and Biomedical Analysis 34, no. 5 (2004): 1013–19. http://dx.doi.org/10.1016/j.jpba.2003.11.002.

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Jain, R. R., P. O. Patil, and S. B. Bari. "SIMULTANEOUS ESTIMATION OF MONTELUKAST SODIUM AND DESLORATADINE IN BULK AND IN TABLET FORMULATION BY UV-SPECTOPHOTOMETRY." INDIAN DRUGS 50, no. 03 (2013): 30–35. http://dx.doi.org/10.53879/id.50.03.p0030.

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Novel, simple, sensitive and rapid spectrophotometric method has been developed for simultaneous estimation of montelukast sodium (MONTE) and desloratadine (DES). The method involved solving simultaneous equations based on measurement of absorbance at two wavelengths 285.6 nm and 245 nm, the λmax values of MONTE and DES, respectively. Beer’s law was obeyed in the concentration range of 4-24 µg/mL and 2– 12 µg/mL for MONTE and DES, respectively. The method was validated for accuracy, precision and recovery studies. The developed method was precise, reproducible, selective, specific and accurate for quantitative estimation of MONTE and DES, in combination. The wide linearity range, sensitivity, accuracy, and simple procedure demonstrated the method to be appropriate for routine analysis and quality control assays of their tablets. The method was validated according to the ICH guidelines.
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&NA;. "Azelastine nasal spray provides greater relief from the symptoms of seasonal allergic rhinitis (SAR) than desloratadine tablets,." Inpharma Weekly &NA;, no. 1527 (2006): 11. http://dx.doi.org/10.2165/00128413-200615270-00022.

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Balusani, Rajitha. "FT-IR SPECTROSCOPIC APPROACH FOR THE QUANTITATIVE ANALYSIS OF FEW COMMERCIAL DRUGS IN BULK AND PHARMACEUTICAL FORMULATIONS." Journal of Advanced Scientific Research 13, no. 05 (2022): 95–104. http://dx.doi.org/10.55218/jasr.202213511.

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Simple, environment-friendly, rapid, accurate and cost effective Fourier Transform Infrared Spectroscopic (FT-IR) methods have been developed for the quantification of Bosentan (BSN), Desloratadine (DSD) and Flunarizine (FNZ) in bulk and marketed formulations. These drugs were estimated by several techniques and a new method has been developed by using FT-IR technique. The methods were developed on the basis of sample concentration influences the intensity of the vibrational bands and linearity is expected between concentration and optical density. The quantity of the drug present in commercial tablets with no interference of the excipients was estimated by applying this proposed method. This method has been validated in terms of LOD, LOQ, precision, accuracy, % RSD, robustness and ruggedness. A factor affecting the absorbance viz., concentration of drug is optimized. The presence of excipients has also been examined and found no significant effect. The calibration curves are found effective for the assessment of pure drug and pharmaceuticals. These curves also can be applied in bulk drug and pharmaceutical industries.
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He, Zhe, Qian Dong, Yue Xi, and Rui Zheng. "Epidermolysis Bullosa Pruriginosa treated with baricitinib: A case report." Medicine 103, no. 27 (2024): e38854. http://dx.doi.org/10.1097/md.0000000000038854.

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Introduction: Epidermolysis Bullosa Pruriginosa (EBP) is a persistent, recurring disease that seriously affects quality of life. Fewer than 100 cases of EBP have been reported to date. Numerous inflammatory dermatoses are driven by soluble inflammatory mediators, which rely on Janus kinase-signal transducer and activator of transcription (JAK-STAT) signaling, and inhibition of this pathway using Janus kinase (JAK) inhibitors might be a useful therapeutic strategy for these diseases. Patient concerns: A male patient, 28 years of age, was admitted to our hospital because of recurrent papules, nodules, and intense itching on the trunk and extremities for 12 years. Repeated large and intense itching has seriously affected the patient normal life. Diagnosis: The patient was diagnosed with EBP based on examination results. interventions: Oral baricitinib tablets (2 mg, once a day) + Oral desloratadine citrate disodium tablets (8.8 mg, once a day) combined with topical compound flumethasone ointment and Fucidin cream. outcomes: The patient skin rashes had subsided and flattened remarkable, and his itching was markedly relieved. The visual analogue scale (VAS) itching score of the patient gradually declined from 8 to 9 points to 2 to 3 points. Conclusion: This study confirms that baricitinib is effective and feasible in treating EBP, especially in remarkable relieving itching, which rendered new ideas for therapeutic approaches for EBP in the future.
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Leontiev, Dmytro, Vasyl Petrus, Natalia Volovyk, and Oleksandr Gryzodub. "A study of the influence of the test sample inhomogeneity on variability in assay results of desloratadine in film-coated tablets." ScienceRise: Pharmaceutical Science, no. 5 (27) (October 31, 2020): 43–51. http://dx.doi.org/10.15587/2519-4852.2020.215287.

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Horak, Friedrich, Ursula Petra Zieglmayer, René Zieglmayer, et al. "Azelastine nasal spray and desloratadine tablets in pollen-induced seasonal allergic rhinitis: a pharmacodynamic study of onset of action and efficacy." Current Medical Research and Opinion 22, no. 1 (2005): 151–57. http://dx.doi.org/10.1185/030079906x80305.

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25

Balitska, О. P., V. S. Zlahoda, O. D. Haiday, O. D. Blahun, and M. A. Artemchuk. "The analysis of the range of antihistamines at the pharmaceutical market of Ukraine." Social Pharmacy in Health Care 9, no. 2 (2023): 74–79. http://dx.doi.org/10.24959/sphhcj.23.293.

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Aim. To analyze the range of antihistamines (AH) at the pharmaceutical market of Ukraine.&#x0D; Materials and methods. The analysis of the range of drugs was carried out in accordance with the State Register of Medicines of Ukraine as of February 2023, the weekly “Apteka” to determine the data of actual sales of AH. Statistical, frequency and graphic methods were used in the analysis. The information was processed using Microsoft Office Excel. &#x0D; Results. As a result of the frequency analysis, it was found that the pharmaceutical market of Ukraine as of February 2023 of AН for systematic use was represented by 170 trade names (TN) and 135 international non-proprietary names (INN). The leaders by INN were Desloratadine (34 TN) and Levocetirizine (26 TN). According to the State Register of Medicines of Ukraine as of February 2023, there were different drug forms, namely: tablets, solutions, drops, syrups, dragees and granules for the preparation of oral suspension. The largest share was AH in the form of tablets (70.59 %), solutions, drops, and syrups accounted for almost the same percentage (10 %, 9,41 %, 8,82 %), and 2 % of AH were registered in the form of dragees. The ratio of AH producing countries at the pharmaceutical market of Ukraine by TN was also determined. It was found that among the dosage forms presented, 62 % were of foreign production. AH of domestic production were 38 %; moreover, the largest market share (19 %) was produced by LLC Pharmaceutical Company “Zdorovye”. According to the results of the official data of weekly “Apteka” on the actual consumption of AH, it was found that AH of the second generation were the most popular both by INN and TN. It is due to their pharmacokinetic properties and the optimal price/effectiveness ratio.&#x0D; Conclusions. Based on the above, we can conclude that the pharmaceutical market of Ukraine is represented by a wide range of AH in various forms of production and various manufacturers. This leads to a wide choice of drugs of this group among the population, pharmaceutical and medical professionals.
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Ibrahim, F. A., N. El-Enany, R. N. El-Shaheny, and I. E. Mikhail. "Simultaneous determination of desloratadine and montelukast sodium using second-derivative synchronous fluorescence spectrometry enhanced by an organized medium with applications to tablets and human plasma." Luminescence 30, no. 4 (2014): 485–94. http://dx.doi.org/10.1002/bio.2764.

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Yurttaş, Ahmet, Elif Büşra Öbek, Deniz Çelik, Özkan Yetkin, and Hüseyin Lakadamyalı. "Management of pulmonary tuberculosis and hypersensitivity reaction to antituberculosis drugs in a patient presenting with recurrent psoas abscess." Intercontinental Journal of Internal Medicine 2, no. 4 (2024): 106–9. http://dx.doi.org/10.51271/icjim-0046.

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Psoas abscess is a difficult disease to diagnose. MTB can cause psoas abscess. First generation anti-TB drugs are used in the treatment of TB, side effects may occur during treatment; one of these side effects is hypersensitivity reactions. In this case report, we aimed to present a patient who presented with recurrent psoas abscess occurs after pulmonary tuberculosis and developed hypersensitivity reaction to antituberculosis drugs and the treatment method we applied. A 44-year-old male patient presented with fever, cough and right flank pain. It was learned that he had hypothyroidism and received antibiotherapy and drainage treatment for recurrent psoas abscesses. His family history was unremarkable and respiratory sounds were normal. Fever was 37.8 °C. WBC: 6.640/mm³, CRP: 70mg/L, ESR: 33mm/h. Liver dynamic CT showed psoas abscess, drainage was provided.Pulmonary tuberculosis was thought to be the etiology of recurrent psoas abscess, thorax CT was ordered and culture and aside resitant staining (ARS) were sent from sputum and abscess upon observation of infiltrations.(Figure 1) No growth was observed in abscess culture and MTB was not detected. With the initiation of HRZE treatment, the patient developed sudden dyspnea, high fever, and skin rashes, and the treatment was terminated. Premedication was decided to be performed before the drug and progressive drug loading was performed to determine the responsible drug. The patient, who had no new allergic reaction during the treatment period, was discharged and methylprednisolone tablets were prescribed for 21 days, bilastine and desloratadine tablets were prescribed for 6 months together with TB drugs. Tuberculosis is among the important causes of morbidity and mortality in developing countries. At the beginning of treatment, patients should be told about the side effects that may occur with the drugs they use. In patients who develop hypersensitivity reactions, temporary or permanent discontinuation of drugs and often hospitalization of the patient is required. Antihistamines and steroids may need to be used for the control of severe reactions.In our case, we wanted to emphasize that patients may develop tuberculosis even if they do not present with pulmonary symptoms and that drug side effects should always be kept in mind and the necessity and importance of premedication and gradual drug loading therapy in patients with hypersensitivity reactions.
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Niu, Suping, Yan Li, Wenliang Dong, et al. "A Randomized Study on the Bioequivalence of Desloratadine in Healthy Chinese Subjects and the Association of Different Metabolic Phenotypes With UGT2B10 and CYP2C8 Genotypes." Current Drug Metabolism 21, no. 13 (2020): 1031–39. http://dx.doi.org/10.2174/1389200221999201027143903.

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Background: Desloratadine is a drug with a phenotypic polymorphism in metabolism and has been approved for use in many countries to treat allergic diseases. CYP2C8 and UGT2B10 are metabolic enzymes, which may be involved in the metabolism of desloratadine. Objective: This study aimed to demonstrate bioequivalence between the test product (desloratadine tablet) and the reference product AERIUS (5mg), both orally administered. And the role of UGT2B10 and CYP2C8 genotypes in healthy Chinese subjects with different Desloratadine metabolic phenotypes was examined. Methods: It was a randomized, open-label, and four-sequence, single-dose crossover study conducted on 56 healthy Chinese subjects. The pharmacokinetics (PK) and safety of the test and reference Desloratadine products were compared. UGT2B10 and CYP2C8 genotypes were determined by the TaqMan assay using genomic DNA. Multiple linear regression was applied to analyze the correlation between genotypes and the metabolic ratio. Results: The mean serum concentration-time curves of desloratadine and 3-OH-desloratadine were similar between the test product and the reference product. For the PK similarity comparison, the 90% CIs for the geometric mean ratios of Cmax, AUC0-t, and AUC0-∞ of desloratadine and 3-OH-desloratadine of test and reference product were completely within 80-125%. None of all 56 subjects had serious adverse events. Only 2 subjects were poor-metabolizers in 56 healthy subjects. There was no significant correlation between investigated genotypes of CYP2C8 and UGT2B10 and the metabolic ratio. Conclusion: The test desloratadine tablet was bioequivalent to the reference product. No direct relationship between CYP2C8 and UGT2B10 genotypes and desloratadine metabolic ratio was identified.
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Zhang, Yu, Jiaming Zhang, Qiuchi Xu, et al. "Simultaneous Determination of Loratadine and Its Metabolite Desloratadine in Beagle Plasma by LC-MS/MS and Application for Pharmacokinetics Study of Loratadine Tablets and Omeprazole‑Induced Drug–Drug Interaction." Drug Design, Development and Therapy Volume 15 (December 2021): 5109–22. http://dx.doi.org/10.2147/dddt.s328106.

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Dr.K.Sujana, Mohammad Mubina. "Method Development and Validation of Simultaneous Estimation of Pseudoephedrine Ambroxol Desloratadine in Tablet Dosage Form and Degradation Studies By Rp-Hplc Method." International Journal of Scientific Research and Management (IJSRM) 5, no. 7 (2017): 5959–97. http://dx.doi.org/10.18535/ijsrm/v5i7.23.

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A simple, Accurate, precise method was developed for the simultaneous estimation of the Pseudoephedrine, Ambroxol and Desloratadine in Tablet dosage form. Chromatogram was run through ODS 250mm x 4.6 mm, 5m. Mobile phase containing Buffer, Acetonitrie and Methanol in the ratio of 50:20A:30M was pumped through column at a flow rate of 1ml/min. Buffer used in this method was 0.01N KH2PO4 buffer at pH 3.2. Temperature was maintained at 30°C. Optimized wavelength for Pseudoephedrine and Ambroxol was 225nm. Retention time of Pseudoephedrine, Ambroxol and Desloratadine were found to be 2.417min, 4.518min and 7.464min respectively. %RSD of the Pseudoephedrine, Ambroxol and Desloratadine were and found to be 1.03 0.64 and 1.15respectively. %Recover was Obtained as 99.92%, 100.21% and 99.92% for Pseudoephedrine, Ambroxol and Desloratadine respectively. LOD, LOQ values are obtained from regression equations of Pseudoephedrine(0.01ppm, 0.02ppm), Ambroxol(0.15ppm, 1.44ppm) and Desloratadine(0.06ppm, 0.17ppm). Regression equation of Pseudoephedrine is y = 16947x + 319.2 Ambroxol is y = 19401x + 3236.and Desloratidine y = 38993x +2051.
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31

Jain, Neha, Amol Kakde, and Mohan Lal Kori. "Simultaneous Method Development for Pseudoephedrine Hydrochloride and Desloratadine." Journal of Drug Delivery and Therapeutics 15, no. 6 (2025): 6–13. https://doi.org/10.22270/jddt.v15i6.7157.

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Introduction: Chromatographic techniques are primarily used for the qualitative and quantitative analysis of pharmaceutical compounds, drug formulations, and raw materials throughout the drug development process, from the early research phase to the final release of therapeutic products. Objective: Simple, accurate, economical and reproducible RP-HPLC method for simultaneous estimation of two component drug mixture pseudoephedrine hydrochloride and desloratadine in combined tablet dosage form. Material and methods: Developed HPLC method is reversed phase chromatographic method using inertsil C18 column and methanol: ammonium acetate buffer in ratio of 70:30 pH 6.5 adjusted with sodium hydroxide, as mobile phase at a flow rate of 1.0ml/ min. The developed method was validated in terms of specificity, linearity, precision, intermediate precision, accuracy, robustness and solution stability. Results: The linearity was observed in concentration range of 12.5-37.5 ug/ml of desloratadine and 450-1350 ug/ml of pseudoephedrine hydrochloride. The results are validated statistically and by recovery studies. The proposed RP-HPLC method achieved satisfactory resolution between desloratadine and pseudoephedrine hydrochloride. It can be used for the synthetic process control and determination of desloratadine in drug substance and pharmaceutical preparation. Conclusion: Quality is paramount in all products and services; a 'regulatory analytical technique' is used to evaluate a distinguishing attribute of raw materials, active pharmaceutical ingredients, and pharmaceutical formulations within the pharmaceutical industry. This method is suitable for routine quality control and stability testing of pseudoephedrine hydrochloride and desloratadine in pharmaceutical formulations. Keywords: RP-HPLC, Simultaneous estimation, Method development, Pseudoephedrine hydrochloride, Desloratadine
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32

Parmar, Kinjal A., Falguni B. Tandel, and Dinesh Rabari. "Analytical Method Development and Validation of Desloratadine Tablet." Research Journal of Pharmacy and Technology 8, no. 6 (2015): 693. http://dx.doi.org/10.5958/0974-360x.2015.00109.2.

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33

Смішко, Р. О., and В. В. Лижнюк. "Development of a technology for a pharmaceutical composition with prolonged release of the antihistamine active pharmaceutical ingredient desloratadine." Farmatsevtychnyi zhurnal, no. 2 (April 28, 2025): 64–77. https://doi.org/10.32352/0367-3057.2.25.06.

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Currently, allergic diseases are a serious medical and social problem of our time due to the rapidly increasing prevalence worldwide. Traditionally, the pharmacotherapy of allergic diseases is based on the use of antihistamines, among which drugs based on the active pharmaceutical ingredient (API) desloratadine in tablet form are among the most popular in the domestic pharmaceutical market. However, the need for daily administration may lead to a decrease in patient compliance and reduced treatment effectiveness. The development of sustained-release medicines based on biodegradable polymers, in particular poly-D,L-lactide-co-glycolide (PLGA) in the form of a gel, which, when injected subcutaneously, forms an implant in situ, is a promising way to solve this problem. The aim of the work is to develop a laboratory technology of a pharmaceutical composition based on a polymeric carrier poly-D,L-lactide-co-glycolide with prolonged release of the antihistamine active pharmaceutical ingredient desloratadine. Three formulations were developed to obtain a pharmaceutical composition of desloratadine in the form of a gel based on PLGA polymer carrier (50:50) and three different solvents: dimethyl sulfoxide (DMSO), ethyl acetate and 2-pyrrolidone, and their effect on the process of formation of a solid implant (depot) after injection into a buffer medium was evaluated. It has been established that the use of DMSO as a solvent in the composition of a pharmaceutical composition in the form of a PLGA-based gel and desloratadine after its injection into a buffer medium with pH = 7.4 ensures the formation of a compact and structured implant, the decomposition of which leads to a gradual prolonged release of antihistamine API over 15 days. A laboratory technology of a pharmaceutical composition based on desloratadine and PLGA polymer carrier (50:50) in the form of a gel has been developed, which, when injected, forms an implant in situ and provides prolonged release of the antihistamine API. The proposed technology is a promising model that can be used to expand the technological base for the development of new sustained-release dosage forms of desloratadine, which will provide effective long-term pharmacotherapy for seasonal and chronic allergic diseases and improve patient adherence to treatment.
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34

Piro, Salar Majeed, and Moyeser Abdulrahman Yaseen. "The effect of intranasal steroid in the treatment of allergic rhinitis with and without oral antihistamine (comparative study)." Advanced medical journal 6, no. 2 (2022): 183–95. http://dx.doi.org/10.56056/amj.2022.149.

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Backgrounds &amp; objectives: Numerous studies have investigated the efficacies of steroid nasal sprays for adults with allergic rhinitis. However, research on their effectiveness in combination with oral antihistamines is limited. This study compared the efficacies of a steroid nasal spray (mometasone furoate) with an oral antihistamine (desloratadine tablet) in the treatment of allergic rhinitis. Methods: A randomized clinical trial was conducted on 120 patients diagnosed with allergic rhinitis. The patients who attended the outpatient department at Rizgary Teaching Hospital in Erbil city were examined for clinical features of allergic rhinitis. Patients with moderate-severe and/or persistent symptoms were included in this study. In this study, 120 patients with allergic rhinitis were randomly assigned to receive mometasone furoate nasal spray alone (control group) and a combination of mometasone nasal spray and oral desloratadine (experimental group). Results: This study showed a statistically significant effect of combination therapy in comparison with intranasal steroids alone. The effect of the combination therapy was more apparent among patients with moderate-severe persistent symptoms. The score was 11.05 in patients who received the combination therapy compared with 7.85 among patients who received single therapy. Conclusions: This study showed that the efficacy of mometasone nasal spray in combination with antihistamine was higher than single steroid nasal sprays therapy
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35

Yeh, Geng-Chang, Shin-Tarng Deng, Chin-Yi Lo, Pei-Shan Chiang, and Cheng-Huei Hsiong. "Pharmacokinetics and Bioequivalence Study of a Generic Desloratadine Tablet Formulation in Healthy Male Volunteers." Arzneimittelforschung 54, no. 03 (2011): 166–70. http://dx.doi.org/10.1055/s-0031-1296954.

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36

Amina Mumtaz, Amina Mumtaz, and Sajjad ul Hassan and Shafaq Mubarak Sajjad ul Hassan and Shafaq Mubarak. "Development and Optimization of Green Method for Antihistamine Using Ecofriendly Reagent in Pure and Pharmaceutical Formulations by Microwave Assisted Spectrophotometry." Journal of the chemical society of pakistan 41, no. 6 (2019): 1028. http://dx.doi.org/10.52568/000810/jcsp/41.06.2019.

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Synthetic substances and solvents utilized in investigation of drugs crumble the earth as well as human health. So attempts should be made to minimize or eliminate the utilization of obnoxious chemicals and solvents. The objective of study is to develop the green spectroscopic method using new ecofriendly chromogenic reagent for the evaluation of antihistamine i.e. desloratadine in pure and commercial dosage forms. Both heating systems (conventional and microwave assisted procedures) are used for the development of color. The method is based on formation of stable blue coloured complex with ammonium molybdate in the presence of acid having λmax at 732nm respectively. All the reaction conditions and different statistic parameters for the proposed methods have been studied. The method is found to be rapid, precise and accurate and can be successfully used for the determination of antihistamines in bulk and commercial tablet formulations.
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Patel, R. B., M. R. Patel, and J. B. Mehta. "Validation of stability indicating high performance liquid chromatographic method for estimation of Desloratadine in tablet formulation." Arabian Journal of Chemistry 10 (February 2017): S644—S650. http://dx.doi.org/10.1016/j.arabjc.2012.10.026.

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Li, Xue-Ning, Hong-Rong Xu, and Wei-Li Chen. "Bioequivalency of single doses of desloratadine administered as syrup and tablet formulations in healthy volunteers in China." World Allergy Organization Journal &NA; (November 2007): S104—S105. http://dx.doi.org/10.1097/01.wox.0000301600.71341.f1.

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39

Mohamed, Eman M., Sathish Dharani, Tahir Khuroo, Rania Hamed, Mansoor A. Khan, and Ziyaur Rahman. "In Vitro and In Vivo Characterization of the Transdermal Gel Formulation of Desloratadine for Prevention of Obesity and Metabolic Syndrome." Pharmaceuticals 16, no. 4 (2023): 578. http://dx.doi.org/10.3390/ph16040578.

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Chronic use of antihistamines can induce abnormalities in lipid absorption with potential excessive accumulation of lipids in the mesentery that can lead to the development of obesity and a metabolic syndrome. The focus of the present work was to develop a transdermal gel formulation of desloratadine (DES) to prevent/reduce obesity and metabolic syndromes. Nine formulations were prepared to contain hydroxypropyl methylcellulose (2–3%), DES (2.5–5.0%), and Transcutol® (15–20%). The formulations were evaluated for cohesive and adhesive properties, viscosity, drug diffusion through synthetic and pig ear skin, and pharmacokinetics in New Zealand white rabbits. Drug permeation was faster through the skin compared to synthetic membranes. The drug had good permeation, as indicated by very short lag time (0.08–0.47 h) and high flux (59.3–230.7 μg/cm2.h). The maximum plasma concentration (Cmax) and area under the curve (AUC) of transdermal gel formulations were 2.4 and 3.2 fold that of the Clarinex tablet formulation. In conclusion, as indicated by the higher bioavailability, transdermal gel formulation of DES may decrease the dose of the drug, compared to commercial formulation. It has the potential to reduce or eliminate metabolic syndromes associated with oral antihistamine therapy.
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Liccardi, Gennaro, Luigino Calzetta, Antonello Salzillo, Gerardo Apicella, Francesco Cavalli, and Paola Rogliani. "Is H1-antihistamine (desloratadine 5 mg, orodispersible tablet) premedication in NSAID-associated urticaria really safe and practicable in “real life”?" Journal of Allergy and Clinical Immunology: In Practice 5, no. 2 (2017): 535. http://dx.doi.org/10.1016/j.jaip.2016.12.019.

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41

Antonijoan, Rosa M., Consuelo Garc??a-Gea, Montserrat Puntes, et al. "A Comparison of Ebastine 10mg Fast-Dissolving Tablet with Oral Desloratadine and Placebo in Inhibiting the Cutaneous Reaction to??Histamine in Healthy Adults." Clinical Drug Investigation 27, no. 7 (2007): 453–61. http://dx.doi.org/10.2165/00044011-200727070-00002.

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Antonijoan, Rosa, Consuelo García-Gea, Montserrat Puntes, et al. "Comparison of inhibition of cutaneous histamine reaction of ebastine fast-dissolving tablet (20 mg) versus desloratadine capsule (5 mg): A randomized, double-blind, double-dummy, placebo-controlled, three-period crossover study in healthy, nonatopic adults." Clinical Therapeutics 29, no. 5 (2007): 814–22. http://dx.doi.org/10.1016/j.clinthera.2007.05.001.

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43

"Formulation of Desloratadine Oral Disintegrating Tablets." Journal of Applied Pharmaceutical Science, November 27, 2014. http://dx.doi.org/10.7324/japs.2014.41110.

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K., L. Deepthi*1 B. Chatrapathi R. Bhaskar B. Jairam L. Gagan Kumar. "FORMULATION AND INVITRO EVALUATION OF MOUTH DISINTEGRATING TABLETS OF MONTELUKAST AND DESLORATADINE." November 30, 2018. https://doi.org/10.5281/zenodo.2530464.

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Montelukast sodium is a leukotriene receptor antagonist, used in the treatment of asthma and Desloratadine is a drug used to treat allergies. The combination formulation is used for the treatment of allergic rhinitis, chronic urticaria. The aim of the present study is to Formulate and evaluate the oral disintegrating tablets of Montelukast sodium and Desloratadine. ODTs were prepared by direct compression method and by using crospovidone, croscarmellose sodium and sodium starch glycollate as superdisintegrants which disintegrates in matter of seconds in the oral cavity, thereby reducing the time of onset of pharmacological action and to reduce the first pass metabolism . Magnesium stearate was used as a lubricant, aspartame as sweetener and orange flavour is used to improve mouth feel.
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AVALIGONDAJAHNAVI, CHAKKA GOPINATH A. RAJESHPAVAN. "FORMULATION AND CHARACTERIZATION OF ORAL DISINTEGRATING TABLETS OF DESLORATADINE." March 28, 2025. https://doi.org/10.5281/zenodo.15102818.

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Orally disintegrating Tablets (ODTs) are an impressive dosage form that breaks down in the&nbsp;mouth upon contact with saliva; thus, they do not require any additional water and&nbsp;disintegrate within seconds, providing a quick onset of action and maximum convenience for&nbsp;oral administration. Patient adherence may be a challenge for bitter medications, as the&nbsp;unpleasant taste could deter usage unless it is adequately masked. Desloratadine is a secondgeneration tricyclic antihistamine that acts selectively as a peripheral H1-antagonist
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46

Hua, Lijuan, Junjun Chen, and Wen Yuan. "Effect of levocetirizine hydrochloride on chronic urticaria and serum levels of total IgE and inflammatory factors." Tropical Journal of Pharmaceutical Research 22, no. 12 (2024). http://dx.doi.org/10.4314/tjpr.v22i12.10.

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Purpose: To investigate the curative effect of levocetirizine hydrochloride tablets on chronic urticaria as well as its mediating effect on serum levels of total IgE and inflammatory factors.&#x0D; Methods: Ninety-two (92) patients with chronic urticaria, were randomly divided into control group (CG) and study group (SG). Patients in CG were treated with oral administration of desloratadine citrate tablets while SG patients received oral levocetirizine hydrochloride tablets. A comparative analysis was conducted between the two patient cohorts encompassing clinical therapeutic outcomes, symptom scoring, T lymphoid subset cell levels, serum total IgE concentrations, serum inflammatory factor levels, as well as adverse reactions.&#x0D; Results: Total treatment effectiveness was higher in SG (97.83 %) than in CG (82.61 %; p &lt; 0.05). After treatment, wheal duration, size and number as well as pruritus scores were markedly lower in SG than in CG, albeit non-significantly (p &gt; 0.05). The levels of CD3+ CD4+, and CD4+/CD8+ ratio in SG after treatment were significantly higher than those in CG (p &lt; 0.05). Furthermore, the serum IgE, IL-4 and IL-13 levels were significantly lower in SG than in CG, while the IFN-γ level was significantly higher (p &lt; 0.05).&#x0D; Conclusion: Levocetirizine hydrochloride tablets produce a significant clinical curative effect on chronic urticaria relative to desloratadine citrate tablets. It reduces the levels of inflammatory factors and mitigates immune dysfunction in patients by increasing the serum level of total IgE. Therefore, it is a potential candidate for further clinical investigations on a larger and more diverse population.
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Mohamed, Yahya Abduh Salim, Tawfeek Ahmed Ali Yahya, and Omaima Abdulbari A. Albarakani. "A new simultaneous salting out thin layer chromatographic method for determination of Loratadine and its active metabolite-desloratadine in pharmaceutical dosage forms and in rabbit spiked plasma." Acta Chromatographica, December 12, 2024. https://doi.org/10.1556/1326.2024.01263.

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AbstractThis research dealing with salting out TLC technique for simultaneous determination of two antihistaminic drugs Loratadine and its active metabolite desloratadine in pure, tablets and rabbit spiked plasma. Separation was performed on silica gel 60 F254 plates using aqueous ammonium sulfate and acetonitrile (6:4, v/v) as a mobile phase. The Rf values were 0.51 ± 0.02 and 0.70 ± 0.004 for Loratadine and desloratadine, respectively in pure or dosage form while in spiked plasma Rf values were 0.39 ± 0.004 and 0.61 ± 0.004 for both drugs respectively using levocetirizine as internal standard (Rf 0.74 ± 0.004). The separated bands were scanned under UV light at λ 254 nm and the TLC chromatograms were captured by camera and treated with Image J software. Method validation was according to ICH and complied with USP31- NF26 guidelines. The correlation coefficients of calibration curves were 0.997 and 0.998 for Loratadine and desloratadine in pure and dosage form while in rabbit spiked plasma were 0.996 and 0.995 for both drugs respectively in the range 100–2,000 μg mL−1. limits of detection LOD and limits of quantitation LOQ for Loratadine and desloratadine were 7.84, 30.06 and 23.52, 91.18 μg mL−1 respectively as pure or as dosage form while LOD and LOQ in rabbit spiked plasma were 17.46, 14.03 and 52.38 and 42.09 μg mL−1 respectively.
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48

R, Bustami, and Khasawneh S. "Bioequivalence of a Fixed Dose Combination of Desloratadine/Betamethasone Tablets (Oradus Beta) in Healthy Human Volunteers." Journal of Bioequivalence & Bioavailability 8, no. 5 (2016). http://dx.doi.org/10.4172/jbb.1000301.

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Çağlar, Sena, and Sıdıka Ertürk Toker. "Simultaneous determination of desloratadine and pseudoephedrine sulfate in tablets by high performance liquid chromatography and derivative spectrophotometry." Reviews in Analytical Chemistry 30, no. 3-4 (2011). http://dx.doi.org/10.1515/revac.2011.100.

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50

Shuma, Madhabi Lata, and Shimul Halder. "Statistical assessment of in vitro drug release kinetics and quality evaluation of desloratadine orally disintegrating generic tablets available in Bangladesh." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector, August 3, 2020, 174113432094775. http://dx.doi.org/10.1177/1741134320947750.

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The objective of the present study was to compare the in vitro equivalence of different orally disintegrating tablets (ODT) of Desloratadine (DES) available in Bangladesh pharmaceutical market with the reference brand. The in vitro dissolution study was carried out using the United States Pharmacopoeia (USP) paddle method and a comparative study were also carried out with the reference brand. Other pharmacopoeial and non-pharmacopoeial quality assessment parameters including hardness, friability, water absorption ratio, and disintegration time etc. were also evaluated. From the results of the dissolution profile of the commercially available products, it found majority of the products didn’t exhibited compendial requirements in dissolution behavior to the reference brand with model-independent approach ( f2 &gt; 50, f1 &lt; 15) and showed statistically significant differences. Additionally, the data of different physical quality parameters revealed that all commercial products complied with the official specifications. From these findings, it could be suggested that the DES-ODT formulations’ available in the Bangladesh market could be prescribed; however additional experiments might require to clarify the interchangeability among the products.
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