ABSTRACT METHOD VALIDATION AND IN-VITRO COMPARATIVE ASSESSMENT OF A FILM-COATED TABLET CONTAINING TELMISARTAN/AMLODIPINE 80/10 VERSUS TWYNSTA® 80/10
Main Article Content
Abstract
Background: The initial combination therapy of telmisartan and amlodipine provides superior blood pressure control compared to monotherapy without increasing adverse effects. However, the poor solubility of telmisartan presents challenges in ensuring its bioavailability and overall drug quality. Therefore, evaluating the in vitro dissolution equivalence of film-coated tablets containing telmisartan 80mg and amlodipine 10mg in comparison to the reference product, Twynsta® 80/10, is essential. Objectives: Validation of the procedure for determining the content of telmisartan and amlodipine besylate in three pH environments of 1.2; 4.5; 6.8 by HPLC/PDA method and to assess the in vitro dissolution equivalence of film-coated tablets containing telmisartan 80mg and amlodipine 10mg compared to the reference tablets. Materials and methods: Validation of the HPLC/PDA method for the determination of telmisartan and amlodipine besylate in dissolution media was performed, assessing system suitability, specificity, linearity, accuracy, and precision. The dissolution study of the test and reference tablets (n=12) was conducted in dissolution media at pH 1.2, pH 4.5, and pH 6.8. The similarity factor (f₂) was calculated for each medium. Results: The validation results demonstrated that the method met the criteria for system suitability, specificity, accuracy, and precision, with an RSD value of ≤ 5.0% across all three pH media. The similarity factor (f₂) values for telmisartan and amlodipine besylate in pH 1.2, 4.5, and 6.8 media were 62.35, 72.72, and 52.57, and 51.96, 75.96, and 70.09, respectively, all exceeding the threshold of 50. Conclusions: The film-coated tablet containing telmisartan 80mg and amlodipine 10mg exhibited in vitro dissolution equivalence to the reference product, Twynsta® 80/10.
Keywords
Telmisartan, amlodipine besylate, in vitro, Twynsta® 80/10
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
References
2. The European Society of Hypertension (ESH) and European Society of Cardiology (ESC). 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. European Heart Journal. 2021. 42, 3282, doi:10.1093/eurheartj/ehab484.
3. Hội Tim mạch học Quốc gia Việt Nam. Khuyến cáo của phân Hội Tăng huyết áp - Hội Tim mạch Quốc gia Việt Nam (vsh/vnha) về chẩn đoán & điều trị tăng huyết áp. 2021.
4. World Health Organization. World Health Organization Model List of Essential Medicines. 2019. 21, 37.
5. Trần Việt Hùng, Huỳnh Thị Mỹ Duyên, Đỗ Châu Minh Vĩnh Thọ. Sinh Dược học. Nhà xuất bản Y học. 2023. 33.
6. Kumar S.P., Nadh H.H.T.V., Venkata R.M., Ramarao N. Enhancement of dissolution rate of telmisartan by inclusion complexes with β-cyclodextrins. International journal of research in pharmacy and chemistry. 2021. 11, (55-63), doi: https://dx.doi.org/10.33289/IJRPC.11,2.2021.11(25).
7. Bộ Y tế. Quy định thuốc phải thử tương đương sinh học và các yêu cầu đối với hồ sơ báo cáo số liệu nghiên cứu tương đương sinh học trong đăng ký lưu hành thuốc tại Việt Nam. 2022.
8. Kim J.E., Park Y.J. QbD Consideration for Developing a Double-Layered Tablet into a SingleLayered Tablet with Telmisartan and Amlodipin besilat. Pharmaceutics. 2022. 14(2), 377, https://doi.org/10.3390/pharmaceutics14020377.
9. United States Pharmacopoeial Convention. The United States Pharmacopoeia 44/ National Formulary-39.
10. ICH Harmonised Guideline Q2(R2). Validation of Analytical procedures. 2022. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q2r2- validationanalytical-procedures-step-2b_en.pdf.
11. Hướng dẫn thực hiện nghiên cứu sinh khả dụng và tương đương sinh học ASEAN, phụ lục 1, (343).
12. Duyen Thi My Huynh, Huynh Thien Hai, Tran Huu Loc, Minh-Ngoc T Le, Phuoc-Vinh Nguyen. Formulation Optimization and Preparation of Amlodipin and Telmisartan Double-layer Tablets (5/40Mg) using Wet Granulation Method. IJDDT. 2024. 14(2), doi: 10.25258/ijddt.14.2.32.