The role of reverse engineering in the development of generic formulations

Pharmaceutical Technology

Volumn 29, Issue 8, 2005, Pages 50-55

  Bansal, Arvind K ^a   Koradia, Vishal ^a  

^a NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH NIPER   (India)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG PRODUCTS; DRUG PRODUCTS PLANTS;

GENERIC DRUG FORMULATIONS;

REVERSE ENGINEERING;

EXCIPIENT; GENERIC DRUG; HYDROXYPROPYLMETHYLCELLULOSE; LACTOSE; STARCH;

BIOEQUIVALENCE; COMMERCIAL PHENOMENA; COST EFFECTIVENESS ANALYSIS; DRUG BIOAVAILABILITY; FOOD AND DRUG ADMINISTRATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHY; NEAR INFRARED SPECTROSCOPY; PARTICLE SIZE; PHARMACEUTICAL ENGINEERING; RAMAN SPECTROMETRY; REVIEW; TABLET COMPRESSION; TABLET DISINTEGRATION; TABLET FORMULATION; X RAY DIFFRACTION;

EID: 23744486069     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (23)

1. J.-M. Peny, "How Bright Is the Future for Generics?" Scrip Magazine 122, 13-17 (2003).
2. P. York, "Solid-State Properties of Powders in the Formulation and Processing of Solid Dosage Forms," Int. J. Pharm. 14 (1), 1-28 (1983).
3. M.N. Martinez and G.L. Amidon, "Mechanistic Approach to Understanding the Factors Affecting Drug Absorption: A Review of Fundamentals," J. Clin. Pharmacol. 42 (6), 620-643 (2002).
4. V. Koradia, G. Chawla, and A.K. Bansal, "Comprehensive Characterization of the Innovator Product: Targeting Bioequivalence Generics," J. Generic Med. (in press).
5. S.R. Byrn et al., "Pharmaceutical Solids: A Strategic Approach to Regulatory Considerations," Pharm. Res. 12 (7), 945-954 (1995).
6. A.S. Raw et al., "Regulatory Considerations of Pharmaceutical Solid Polymorphism in Abbreviated New Drug Applications (ANDAs)," Adv. Drug Del. Rev. 56 (3), 397-414 (2004).
7. FDA, Federal Register 57, 17958-17959 (April 28, 1992).
8. J.K. Haleblian, "Characterization of Habits and Crystalline Modification of Solids and their Pharmaceutical Applications," J. Pharm. Sci. 64 (8), 1269-1288 (1975).
9. D.J.W. Grant, "Theory and Origin of Polymorphs," in Polymorphism in Pharmaceutical Solids, H.G. Brittain, Ed. (Marcel Dekker, New York, NY, 1999), pp. 1-33.
10. D. Giron, "Thermal Analysis and Calorimetric Methods in Characterisation of Polymorphs and Solvates," Thermochim. Acta. 248, 1-59 (1995).
11. D. Giron, "Contribution of Thermal Methods and Related Techniques to the Rational Development of Pharmaceuticals: Part 1," Pharm. Sci. Tech. Today 1 (5), 191-199 (1998).
12. J. Bauer et al., "Ritonavir: and Extraordinary Example of Conformational Polymorphism," Pharm. Res. 18 (6), 859-866 (2001).
13. W. Liebenberg et al., "Identification of the Mebendazole Polymorphic Form Present in Raw Materials and Tablets Available in South Africa," Drug Dev. Ind. Pharm. 24 (5), 485-488 (1998).
14. R.J. Terblanche et al., "Characterization of Zopiclone Crystal Forms among Generic Raw Materials," Drug. Dev. Ind. Pharm. 26 (5), 531-537 (2000).
15. N.V. Phadnis and R. Suryanarayanan, "Polymorphism in Anhydrous Theophylline: Implications on the Dissolution Rate of Theophylline Tablets," J. Pharm. Sci. 86 (11), 1256-1263 (1997).
16. S.Q. Henwood et al., "Solubility and Dissolution Properties of Generic Rifampicin Raw Materials," Drug Dev. Ind. Pharm. 26 (4), 403-408 (2000).
17. A. Kristl et al., "Polymorphism and Pseudopolymorphism: Influencing the Dissolution Properties of the Guanine Derivative Acyclovir," Int. J. Pharm. 139 (1-2), 231-235 (1996).
18. B.C. Hancock and G. Zografi, "Characteristics and Significance of the Amorphous State in Pharmaceutical Systems," J. Pharm. Sci. 86 (1), 1-12 (1997).
19. E. Swanepoel et al., "Dissolution Properties of Piroxicam Powders and Capsules as a Function of Particle Size and the Agglomeration of Powders," Drug. Dev. Ind. Pharm. 26 (10), 1067-1076 (2000).
20. M. Otsuka, M. Nakanishi, and Y. Matsuda, "Effects of Crystalline Form on the Tableting Compression Mechanism of Phenobarbital Polymorphs," Drug. Dev. Ind. Pharm. 25 (2), 205-212 (1999).
21. M.V. Dali and J.T. Carstensen, "Effect of Change in Shape Factor of a Single Crystal on its Dissolution Behavior," Pharm. Res. 13 (1), 155-162 (1996).
22. A.K. Tiwary and G.M. Panpalia, "Influence of Crystal Habit on Trimethoprim Suspension Formulation," Pharm. Res. 16 (2), 261-265 (1999).
23. S. Sun and D. J. W. Grant, "Influence of Crystal Structure on the Tableting Properties of Sulfamerazine Polymorphs," Pharm. Res. 18 (3), 274-280 (2001).