scholarly journals Validation of methodology for assay, pharmaceutical equivalence, and comparative dissolution profile for tablets containing amlodipine besylate

2019 ◽  
Vol 9 (11) ◽  
pp. 93-100
Keyword(s):  
Dissolution Profile ◽  
Amlodipine Besylate ◽  
Pharmaceutical Equivalence ◽  
Comparative Dissolution

Physicochemical Evaluation of Brands of Amlodipine Besylate Tablets.

2020 ◽  
Vol 1 (5) ◽  
pp. 24-33
Author(s):  
C.A. Anyanwu-Ndulewe ◽  
◽  
L.E. Mogbolu ◽  
M.A. Oladunni ◽  
A.A. Adepoju-Bello
Keyword(s):  
Hardness Test ◽  
Drug Market ◽  
The United States ◽  
Financial Strain ◽  
Average Weight ◽  
Dissolution Profile ◽  
Amlodipine Besylate ◽  
Disintegration Time ◽  
Physicochemical Evaluation ◽  
Dissolution Efficiency

Background: Hypertension is a chronic condition, and the cost of filling prescriptions has a potential of putting a financial strain on patients, hence the need for lower priced but bioequivalent generics. The Nigerian drug market is awash with generics of Amlodipine besylate, a first line drug in the treatment of hypertension, therefore, any prescribed alternative must be bioequivalent to the originator. Objectives: This study assessed the physicochemical properties of some brands in order to predict pharmaceutical and bioequivalence and invariably, the interchangeability with the innovator brand. Methods: Compendial parameters of average weight, friability, disintegration, drug content and dissolution profile of ten generic brands were evaluated using the United States Pharmacopeia (USP) as well as the non-official hardness test. Results: Two brands failed the test for hardness, while still keeping to the stipulated friability limit. All the brands met the required disintegration time, irrespective of the discordance of some brands in the breaking force and friability values. All brands were found to contain between 92.00 and 103.57% (w/w) of Amlodipine besylate. Two brands failed to achieve ≥75% dissolution expected at 30 minutes and this was reflected in the low f2 values of 35.06% and 28.73%. The dissolution curves displayed a similarity for two brands, which was also corroborated by the high percentage dissolution efficiency (DE) of 92.00%, as well as the f1 and f2 values, compared to the innovator brand. Conclusion: Although the parameters used may predict therapeutic equivalence, interchangeability with the comparator brand is subject to relevant bioequivalence studies.

scholarly journals Uji Disolusi Terbanding Tablet Ofloxacin Berlogo dan Generik Bermerek Terhadap Inovator Dalam Media Dapar HCl pH 4,5

2017 ◽  
Vol 4 (1) ◽  
Author(s):  
Winsa Wira Wijaya ◽  
Prima Happy Ratnapuri ◽  
Mia Fitriana
Keyword(s):  
Acetate Buffer ◽  
Dissolution Profile ◽  
Dissolution Test ◽  
Branded Drug ◽  
Similarity Factor ◽  
Difference Factor ◽  
Zwitter Ion ◽  
Dissolution Efficiency ◽  
Comparative Dissolution

ABSTRAK Uji disolusi terbanding merupakan pengujian yang dapat digunakan untuk memastikan ekivalensi dan sifat-sifat produk obat. Uji disolusi terbanding dilakukan dalam media disolusi dengan pH yang disesuaikan dengan kondisi in vivo yaitu pada pH 1,2; 4,5; dan 6,8. Obat generik dan generik bermerek yang wajib uji ekivalensi salah satunya yaitu ofloxacin. Ofloxacin merupakan suatu obat yang memiliki sifat kationik, anionik, dan zwitter ion. Penelitian ini bertujuan untuk menentukan ekivalensi profil disolusi terbanding yang dianalisis dengan parameter f1, f2, dan DE70 antara ofloxacin generik berlogo dan generik bermerek terhadap inovator dalam media dapar asetat pH 4,5. Uji disolusi dilakukan sesuai USP 32-NF 27 yaitu menggunakan alat uji tipe 2 pada suhu 37 ± 0,50C dengan kecepatan putar 50 rpm. Analisis hasil yang digunakan untuk menentukan ekivalensi profil disolusi yaitu difference factor (f1), similarity factor (f2), dan dissolution efficiency (DE70). Hasil penelitian ini memberikan kesimpulan bahwa sampel yang memiliki ekivalensi profil disolusi terbanding yang dianalisis dengan parameter f1, f2, dan DE70 terhadap produk inovator dalam media dapar asetat pH 4,5 yaitu sampel A (generik bermerek) dan sampel B (generik berlogo). Kata kunci : ofloxacin, disolusi terbanding, difference factor (f1), similarity factor (f2), dan dissolution efficiency (DE70). ABSTRACT Comparative dissolution is a test that can be used to ensure equivalence and properties of medicinal products. Comparative dissolution test has done in a dissolution medium with pH adjusted to in vivo conditions at pH 1,2; 4,5; and 6,8. One of generic and generic branded drug that need equivalence test is ofloxacin. Ofloxacin is a drug which are cationic, anionic, and zwitter ion. The aim of this study was to determine equivalence comporative of dissolution profiles, then analyzed with f1, f2, and DE70 parameters between generic and generic branded to innovators ofloxacin in media acetate buffer pH 4,5. Dissolution test was accordance to USP 32-NF 27 that used equipment test type 2 at temperature 37 ± 0,50 C with rotary speed 50 rpm. The analysis results were used to determine equivalence dissolution profile e.g. difference factor (f1), similarity factor (f2), and dissolution efficiency (DE70). The results this study showed that samples had equivalence comporative of dissolution profiles which were analyzed with f1, f2, and DE70 parameters to innovator product in media acetate buffer pH 4,5 was sample code A (generic branded) and sample code B (generic). Keywords: ofloxacin, comparative dissolution, difference factor (f1), similarity factor (f2), and dissolution efficiency (DE70).

scholarly journals In vitro Pharmaceutical Equivalence Study of Three Brands of Atenolol Tablets Available in Bangladesh

2019 ◽  
Vol 18 (1) ◽  
pp. 43-48
Author(s):  
Rehana Begum ◽  
Md Zakir Sultan ◽  
Jakir Ahmed Chowdhury ◽  
Md Shah Amran
Keyword(s):  
In Vitro Dissolution ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
United States Pharmacopoeia ◽  
Dissolution Study ◽  
Pharmaceutical Equivalence ◽  
Similarity Factor ◽  
Difference Factor ◽  
Paddle Apparatus

The aim of the present work was to assess the pharmaceutical equivalence of three brands of atenolol (50 mg) tablets available in Bangladesh using in vitro dissolution study. The dissolution study was carried out using the paddle apparatus according to the guidelines of United States Pharmacopoeia (USP). The dissolution profiles of three locally manufactured atenolol tablets were determined and compared with the dissolution profile of atenolol tablet from innovator’s company. All samples attained more than 85% dissolution within 10 minutes. Mean dissolution values were employed to estimate difference factor (f1) and similarity factor (f2). Difference factor (f1) and similarity factor (f2) were used to assess in vitro bio-equivalency among the three brands. Other general quality assessment parameters such as hardness, friability and disintegration time were also determined. All brands complied with the official specifications for hardness, friability and disintegration time. The study indicated that all brands can be prescribed interchangeably. Dhaka Univ. J. Pharm. Sci. 18(1): 43-48, 2019 (June)

scholarly journals Alternative Methods for Dissolution Profile Comparison in the Dissolution Test

2021 ◽  
Vol 10 (4) ◽  
pp. 197-207
Author(s):  
D. P. Romodanovsky ◽  
D. V. Goryachev
Keyword(s):  
Active Substance ◽  
Dissolution Kinetics ◽  
Alternative Methods ◽  
Drug Dissolution ◽  
Dissolution Profile ◽  
Dissolution Test ◽  
Similarity Factor ◽  
Model Independent ◽  
Kinetics Of ◽  
Comparative Dissolution

Introduction. The article discusses the problem of assessing the similarity of the dissolution profiles of two batches of the nebivolol. The use of a generally accepted similarity factor for assessing equivalence is unacceptable in some cases, for example, for drugs with a high variability in the values of the release of the active substance from the formulation. At the same time, at present, there are no generally accepted approaches to comparing the profiles of the dissolution kinetics of drugs, with the exception of the method for assessing the comparability of profiles based on the mathematical calculation of the similarity factor f2, which has certain criteria that limit its application.Aim. To demonstrate alternative methods for assessing the similarity between the dissolution profiles of two drugs using a practical example.Materials and methods. The results of the comparative dissolution test of two series of nebivolol at a dosage of 5 mg. Five model-independent methods for assessing the equivalence of drug dissolution were used. Statistical data processing was performed using Microsoft Excel software.Results and discussion. The paper presents a practical example of using five alternative model-independent methods for assessing the equivalence of the dissolution profile. An example is used to illustrate the proposed equivalence limits and statistical methodology. Also, various approaches to determining the boundaries of equivalence have been proposed to assess the similarity of the dissolution profiles of an active substance.Conclusion. According to the results of the comparative dissolution test of two batches of nebivolol, it was shown that the use of the similarity factor as a criterion for assessing dissolution profiles led to a false positive result. In such cases, the possibility of using alternative methods for assessing the equivalence of dissolution profiles described in the article, or other methods presented in the scientific literature, should be considered, with a justification of their acceptability in each specific case.

scholarly journals The Effect of Crospovidone on the Dissolution Profile of Amlodipine Besylate from Fast Orally Dissolving Film

2019 ◽  
Vol 7 (22) ◽  
pp. 3811-3815
Author(s):  
Sumaiyah Sumaiyah ◽  
Julia Mentari ◽  
Suryanto Suryanto
Keyword(s):  
Mentally Ill ◽  
Hydroxypropyl Methylcellulose ◽  
Dissolution Profile ◽  
Amlodipine Besylate ◽  
Solid Dosage Forms ◽  
Drug Induced ◽  
Disintegration Time ◽  
Solid Dosage ◽  
Rapid Dissolution ◽  
Agent Characteristics

BACKGROUND: Fast Orally Dissolving Film preparation can be used for patients with problems in ingesting solid dosage forms, such as mentally ill, elderly, geriatric and patients who are reducing fluid intake or nausea. AIM: This study aimed to formulate and evaluate the rapid dissolution of amlodipine besylate. METHODS: Amlodipine besylate film was prepared by solvent casting method by using hydroxypropyl methylcellulose (HPMC) as film formers, crospovidone as superdisintegrant with Varian concentration F1 (2%), F2 (4%), F3 (6%) and F4 (8%), PEG 400 as plasticizer, sucralose and sorbitol as sweetener, citric acid as saliva stimulation, and grape essence as flavoring and coloring agent. Characteristics of films include organoleptic, weight uniformity, film thickness, surface pH, swelling, uniformity of content, time of disintegration, and dissolution. RESULTS: All formulated films produced a good film, smooth, transparent and uniform physical properties. F2 with polymer HPMC and the 4% concentration of crospovidone was the best formula with 31.50 seconds of disintegration time, the index expanding at the 15 second by 242.29% and the cumulative percent of the drug at 80 seconds by 98.08%. CONCLUSION: Amlodipine besylate can be formulated into fast orally dissolving film preparations using HPMC and crospovidone polymers so that they may be considered for use in the treatment of hypertension for patients with drug-induced problems in tablet or capsule form.

scholarly journals Impact Evaluation of Changes in the Manufacturing Line of Cyproterone Acetate through Analysis of Comparative Dissolution Profile

2014 ◽  
Vol 1 (2) ◽  
pp. 107-114
Author(s):  
Terezinha de Jesus Andreoli Pinto ◽  
Rogério Takao Okamoto ◽  
Wesley Anderson de Oliveira ◽  
Daniela Dal Molim Ghisleni
Keyword(s):  
Impact Evaluation ◽  
Cyproterone Acetate ◽  
Dissolution Profile ◽  
Manufacturing Line ◽  
Comparative Dissolution
Sign in / Sign up

Export Citation Format

Share Document