DISSOLUTION PROFILE OF AMBROXOL HCl TABLET WITH ADDITIONAL VARIATIONS OF LUDIPRESS® AND LACTOSE USING THE DIRECT PRESS METHOD
Objective: The drug will provide a therapeutic effect when dissolved so that it is easily absorbed. The process of dissolving drugs is called dissolution. Additional substances contained in pharmaceutical preparations, one of which serves to accelerate the solubility of active substances. The aim of this study was to obtain a comparative composition of Ludipress® and lactose additives suitable for producing ambroxol HCl tablets that met the requirements. Methods: Ambroxol HCl tablets were made by direct pressing method. Made 4 formulas with variations of Ludipress® and Lactose. The tablet was then evaluated which includes uniformity in weight, diameter, thickness, hardness, friability, disintegration time, and dissolution. Data obtained in the analysis using the perfect random block design method (DBAS) with α = 0.05 where blocks and groups are used. Results: Dissolution test results show that one of the four formulas meets the solubility requirements in the European Pharmacopeia. European Pharmacopoeia states that the dissolved concentration of the active substance of a tablet is not less than 75% during 45-minute testing. Results: The dissolution test results showed that in the 45-minute test each percent dissolved concentration of the active substance for F1, F2, F3, and F4 was 58.77974, 66.91104, 80.09946, and 64.02293. European Pharmacopoeia states that the dissolved concentration of the active substance of a tablet is not less than 75% during 45-minute testing. Conclusion: The formula that meets the solubility requirements consists of an additional 69% Ludipress® and 10% lactose with a solubility value of 80.09%.
2. Khadka P, Ro J, Kim H, Kim I, Kim JT, Kim H, et.al. Pharmaceutical particle technologies: An approach to improve drug solubility, dissolution, and bioavailability, Asian Journal of Pharmaceutical Sciences 2014;9(6),304-16. https://doi.org/10.1016/j.ajps.2014.05.005
3. Jaysukh J Hirani JJ, Rathod DA, Vadalia KR. Orally Disintegrating Tablets: A Review, Trop J Pharm Res 2009;8 (2):161-72.
4. Brown CK, Friedel HD, Barker AR, Buhse LF, Keitel S, Cecil TL, et.al. Meeting Report: FIP/AAPSJoint WorkshopReport: Dissolution/InVitro Release Testing of Novel/Special Dosage Forms, AAPSPharmSciTech(#2011). DOI: 10.1208/s12249-011-9634-x
5. BASF. Technical Information. Germany: BASF Chemical Industry. 2003
6. Heinz R, Karbstein HP, Wolf H, End L. Formulation and Development of Tablets Based on Ludipress and Scale-Up from Laboratory to Production Scale, ?Drug Development and Industrial Pharmacy 2000;26(5):513-21. DOI: 10.1081/DDC-100101262
7. Malerba M, Ragnoli B. Ambroxol in the 21st century: pharmacological and clinical update, Expert Opin Drug Metab Toxicol 2008;4 (8):1119–29.DOI:10.1517/17425255.4.8.1119
8. McNeill A, Magalhaes J, Shen C, Chau KY, Hughes D, Mehta A, et.al. Ambroxol improves lysosomal biochemistry in glucocerebrosidase mutation-linked Parkinson disease cells. Brain 2014;137(Pt 5):1481–95. DOI:10.1093/brain/awu020
9. Ambroxol Hydrochloride. Available from: https://www.drugs.com/ambroxol.html (Download January 5, 2020)
10. Departemen Kesehatan Republik Indonesia. Farmakope Indonesia. Edisi III. Jakarta: Departemen Kesehatan Republik Indonesia,1979.
11. Departemen Kesehatan Republik Indonesia. Farmakope Indonesia. Edisi IV. Jakarta: Departemen Kesehatan Republik Indonesia, 1995
12. Beringer P. Remington The Science and Practice of Pharmacy. Twenty-first edition. Philadelphia: Lippincott Williams & Wilkins. 2005: p. 889-91.
13. Gibson M (Editors). 2004. Pharmaceutical Pre-formulation and Formulation. Florida : CRC Press, 2004: p. 417-8.
14. Aulton ME. Pharmaceutics: The Science of Dosage Form Design. New York: Longman Group Churchill Livingstone, 2002: p. 02, 124, 246-48
15. United States Pharmacopeial Convention. The United States Pharmacopeia 30. Twinbrook Parkway MD: United States Pharmacopeial Convention, Inc. 2007
16. European Pharmacopoeia Commission. European Pharmacopoeia 6. Council of Europe, 2007.
17. Trochim WMK. Research Methods Knowledge Base. Available from: https://socialresearchmethods.net/kb/randomized-block-designs/. (Download January 6, 2020)
18. Grant T. The Randomized Complete Block Design (RCBD). Available from: https://pbgworks.org/sites/pbgworks.org/files/RandomizedCompleteBlockDesignTutorial.pdf. (Download January 6, 2020)
19. Rowe RC, Sheskey PJ, Cook WG, Quinn ME (Editors). Handbook of Pharmaceutical Excipients – 7th Edition, Pharmaceutical Development and Technology, UK: The Pharmaceutical Press 2013; 18:2, 544, DOI: 10.3109/10837450.2012.751408
20. Mustarichie R, Priambodo D. TABLET FORMULATION FROM MENIRAN (PHYLLANTHUS NIRURI L.) EXTRACT WITH DIRECT COMPRESSION METHOD, Int JApp Pharm 2018;10(4):98-102.DOI: 10.22159/ijap.2018v10i4.267
21. Li Q, Guan X, Cui M, Zhu Z, Chen K1, Wen H, et.ali. Preparation and investigation of novel gastro-floating tablets with 3D extrusion-based printing, Int J Pharm. 2018; 15;535(1-2):325-332. doi: 10.1016/j.ijpharm.2017.10.037.
22. The United States Pharmacopeia. The National Formulary 23. 29th Edition. Volume I. Washington, D.C: United States Pharmacopeia Convention Inc.;2006
23. Pandey S, Pandey P, Tiwari G, Tiwari R, and Rai AK. FTIR Spectroscopy: A Tool for Quantitative Analysis of Ciprofloxacin in Tablets, Indian J Pharm Sci 2012;74: 86–90. DOI: 10.4103/0250-474X.102551
24. Sharma D, Singh M, Kumar D, and Singh G. Simultaneous Estimation of Ambroxol Hydrochloride and Cetirizine Hydrochloride in Pharmaceutical Tablet Dosage Form by Simultaneous Equation Spectrophotometric Method: A Quality Control Tool for Dissolution Studies, ISRN Analytical Chemistry 2014; 2014 1-6. DOI: 10.1155/2014/236570
25. Basak SC, Mani KPL, Reddy BMJ. Formulation and release behavior of sustained-release ambroxol hydrochloride HPMC matrix tablet, Indian Journal of Pharmaceutical Sciences 2006;68(5):594-598.DOI: 10.4103/0250-474X.29626
26. Hull University Teaching Hospitals NHS Trust. A Study of the Effect of 20 mg Ambroxol Hydrochloride on Acute Cough. Available from: https://clinicaltrials.gov/ct2/show/NCT03415269. Download January 5, 2020
27. Sandhya KM, Shanmugam S, and Vetrichelvan T. Design and development of ambroxol hydrochloride sustained release matrix tablets, IntJPharmPharmSci 2011;13(Suppl3):2003
28. Abd-Elbary A, Haider M, and Sayed S. In vitro characterization and release study of Ambroxol hydrochloride matrix tablets prepared by direct compression, Pharmaceutical Development and Technology 2012; 17(5):562-73. DOI: 10.3109/10837450.2011.557728
29. Rangnath RA, Kumar JH, Namdeorao GK. Development and validation for UV Spectrometric estimation of ambroxol hydrochloride in bulk and tablet dosage form using the area under curve method. Int. Res. J. Pharm. 2014;5 (7):580-3. DOI: 10.7897/2230-8407.0507118
30. Akhter DT, Uddin R, Sutradhar KB, and Rana S. In vitro release kinetic study of ambroxol hydrochloride sustained release matrix tablets using hydrophilic and hydrophobic polymers, J. Chem. Pharm. Res., 2012, 4(3):1573-9.
31. Hang TJ, Zhang M, Song M, Shen JP, Zhang YD. Simultaneous determination and pharmacokinetic study of roxithromycin and ambroxol hydrochloride in human plasma by LC-MS/MS, Clin Chim Acta. 2007;382(1-2):20-4. DOI:10.1016/j.cca.2007.03.015
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