The differences between the branded and generic medicines using solid dosage forms: In-vitro dissolution testing

Results in Pharma Sciences

Volumn 2, Issue 1, 2012, Pages 1-8

  Ameri, Mubarak Nasser Al ^a,b   Nayuni, Nanda ^a   Anil Kumar, K G ^b   Perrett, David ^a   Tucker, Arthur ^a   Johnston, Atholl ^a  

^a QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^b UAE General Hospital   (United Arab Emirates)

Author keywords

Absorption; Differences between the branded and generic medicines; Dissolution methods IVIVC; In vitro dissolution

Indexed keywords

AMOXICILLIN; AMOXICILLIN PLUS CLAVULANIC ACID; CAPECITABINE; CIPROFLOXACIN; DICLOFENAC; GENERIC DRUG; LORATADINE; MEFENAMIC ACID; MELOXICAM; NIFEDIPINE; OMEPRAZOLE; SIMVASTATIN;

ARTICLE; DRUG BIOAVAILABILITY; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRUG INDUSTRY; DRUG SOLUBILITY; FOOD AND DRUG ADMINISTRATION; IN VITRO STUDY; PRIORITY JOURNAL; SOLID DOSAGE FORM; SPECTROPHOTOMETRY; DRUG MANUFACTURE; PRACTICE GUIDELINE; ULTRAVIOLET SPECTROPHOTOMETRY; COMPARATIVE STUDY;

EID: 84055200500     PISSN: None     EISSN: 22112863     Source Type: Journal    
DOI: 10.1016/j.rinphs.2011.12.001     Document Type: Article

References (39)

1. Simoens S. Generic and therapeutic substitution: ethics meets health economics. International Journal of Clinical Pharmacology 2011;33(3):469-70.
2. Frank RG. The ongoing regulation of generic drugs. New England Journal of Medicine 2007;357(20):1993-6.
3. Kozlowski S, et al. Developing the Nation's Biosimilars Program. New England Journal of Medicine 2011;365(5):385-8.
4. Kamerow D. The pros and cons of generic drugs. British Medical Journal 2011:d4584343 2011:d4584.
5. Adegbolagun OA, Olalade OA, Osumah SE. Comparative evaluation of the biopharmaceutical and chemical equivalence of some commercially available brands of ciprofloxacin hydrochloride tablets. Tropical Journal of Pharmaceutical Research 2007;6(3):737-45.
6. Al Ameri MN, et al. A survey to determine the views of renal transplant patients on generic substitution in the UK. Transplant International 2011; 24(8):770-9.
7. Hua Zhang, Yu LX. Dissolution testing for solid oral drug products: theoretical considerations. American Pharmaceutical Review 2004;7(5):26-31. September/October.
8. Savaser A, Ozkan Y, Isimer A. Preparation and in vitro evaluation of sustained release tablet formulations of diclofenac sodium. Farmaco 2005;60(2):171-7.
9. Venkata Ramana SU. Regulatory perspectives on in vitro (dissolution)/in vivo (bioavailability) correlations. Journal of Controlled Release 2001;72(1-3): 127-32.
10. Brief T. In vitro dissolution testing for solid oral dosage forms, March 12, 2010. Available from: .
11. Dressman JB, et al. Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms. Pharmaceutical Research 1998;15(1):11-22.
12. Guo JH, et al. Validation of tablet dissolution method by high-performance liquid chromatography. Drug Development and Industrial Pharmacy 2000;26(3):337-42.
13. Singla N, et al. A discriminatory and biorelevant dissolution test method for simvastatin drug products, November 2009 July 23, 2011. Available from: .
14. Zahirul M, Khan I. Dissolution testing for sustained or controlled release oral dosage forms and correlation with in vivo data: Challenges and opportunities. International Journal of Pharmaceutics 1996;140(2):131-43.
15. Oliveira ÉdFS, et al. Dissolution test optimization for meloxicam in the tablet pharmaceutical form. Brazilian Journal of Pharmaceutical Sciences 2009: 67-7345 2009:67-73.
16. Cynthia K. Brown, et al. Acceptable analytical practices for dissolution testing of poorly soluble compounds, 2004 July 18, 2011. Available from: .
17. Food and Drug Administration (FDA). Guidance for industry: dissolution testing of immediate release solid oral dosage forms, August 1997 May 5. 2011. Available from: .
18. European Medicines Agency (EMA). Note for guidance on the investigation of bioavailability and bioequivalence, July 16, 2001 January 26, 2010. Available from: .
19. Pharma Test. PT-DT70, July 18, 2011. Available from: .
20. Cox DD, et al. Guidelines for dissolution testing, April 1978 May 11, 2011. Available from: .
21. Commission on Human Medicines, British Pharmacopoeia 2011, VIII, pp. 2305-3326. vol. 3.
22. Council of Europe-Strasbourg, European Pharmacopoeia 2007, 6th ed
23. The United states Pharmacopoeia Convention, US Pharmacopoeia 2010, VIII, pp. 2505-3504.
24. European Medicines Agency (EMA). Note for guidance on validation of analytical procedures: text and methodology, June 1995 June 14th, 2011. Available from: .
25. Bertocchi P, et al. Diclofenac sodium multisource prolonged release tablets-a comparative study on the dissolution profiles. Journal of Pharmaceutical and Biomedical Analysis 2005;37(4):679-85.
26. Shinkuma D, et al. Correlation between dissolution rate and bioavailability of different commercial mefenamic acid capsules. International Journal of Pharmaceutics 1984;21(2):187-200.
27. Olling M, et al. Bioavailability of carbamazepine from four different products and the occurrence of side effects. Biopharmaceutics & Drug Disposition 1999;20(1):19-28.
28. Veronin MA, Nguyen NT. Comparison of simvastatin tablets from the US and international markets obtained via the internet. The Annals of Pharmacother-apy 2008;42(5):613-20.
29. Pharmainfo.net. Dissolution. 2008 July 10th, 2011. Available from: .
30. Mansoor S, Sharma R, Dhakal S. Comparative in vitro evaluation of commercially available pantoprazole tablets. Kathmandu University Journal of Science, Engineering and Technology 2007;1(3). January.
31. Singla N, et al. A discriminatory and biorelevant dissolution test method for simvastatin drug products. Dissolution technologies, November, 2009 June 13, 2011. Available from: .
32. Risha PG, et al. Drug formulations intended for the global market should be tested for stability under tropical climatic conditions. European Journal of Clinical Pharmacology 2003;59(2):135-41.
33. El-Sayed A, et al. Assessment of the pharmaceutical quality of omeprazole capsule brands marketed in Egypt. Eastern Mediterranean Health Journal 2007;13(6):1427-37.
34. Al Ameri M, Epstein M, Johnston A. Generic and therapeutic substitutions: are they always ethical in their own terms? Pharmacy World and Science 2010;32(6):691-5.
35. Iheanacho I,Blythe J. What are excipients doing in medicinal products? 2009 February 15, 2010. Available from: .
36. Wandel C, Kim RB, Stein CM. "Inactive" excipients such as cremophor can affect in vivo drug disposition. Clinical Pharmacology & Therapeutics 2003;73(5):394-6.
37. Guzik L, Mrozik W, Kamysz W. Determination of simvastatin in pharmaceutical dosage forms by optimized and validated method using HPLC/UV. Croatica Chemica Acta 2010;83(4):371-7.
38. Dokoumetzidis A, Macheras P. A century of dissolution research: from Noyes and Whitney to the biopharmaceutics classification system. International Journal of Pharmacology 2006;321(1-2):1-11.
39. Heisterberg J. Generic substitution terminated for oral medicines containing cyclosporine or tacrolimus, July 13th, 2011 September 1 1th, 2011. Available from: .