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AAPS PharmSciTech. 2003 March; 4(1): 43–52.
Published online 2003 February 14. doi:  10.1208/pt040107
PMCID: PMC2750303

FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.
1. FIP guidelines for dissolution testing of solid oral products [Duplicate publication of FIP guidelines for dissolution testing of solid oral products. Pharm Ind. 1997;59:760–766]. Dissolut Technol. 1997;4:5–14.
2. FDA guidance for Industry: dissolution testing of immediate release solid oral dosage forms, August 1997; extended release solid oral dosage forms: development, evaluation and application of in vitro/in vivo correlations, September 1997. [PubMed]
3. USP 24/NF 19, left angle bracket1088right angle bracket 2000:2051.
4. FDA Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations. October 2000.
5. Shah VP, Tymes NW, Skelly JP. In vitro release profile of clonidine transdermal therapeutic systems and scopolamine patches. Pharm Res. 1989;6:346–351. doi: 10.1023/A:1015962911344. [PubMed] [Cross Ref]
6. Shah VP, Elkins JS, Williams RL. Evaluation of the test system used for in vitro release of drugs from topical dermatological drug products. Pharm Develop Technol. 1999;4:377–385. doi: 10.1081/PDT-100101373. [PubMed] [Cross Ref]
7. Fares HM, Zatz JL. Measurement of drug release from topical gels using two types of apparatus. Pharm Tech. 1995;19(1):52–58.
8. Shah VP, Elkins JS. In vitro release from corticosteroid ointments. J Pharm Sci. 1995;84:1139–1140. doi: 10.1002/jps.2600840920. [PubMed] [Cross Ref]
9. Higuchi WI. Analysis of data on medicament release from ointments. J Pharm Sci. 1962;51:802–804. doi: 10.1002/jps.2600510825. [PubMed] [Cross Ref]
10. FDA Guidance for Industry: SUPAC-SS Nonsterile Semisolid Dosage Forms. Scale-Up and Post Approval Changes: Chemistry, Manufacturing, and Controls; in Vitro Release Testing and in Vivo Bioequivalence Documentation. May 1997.
11. Flynn GL, Shah VP, Tenjarla SN, et al. Assessment of value and applications of in vitro testing of topical dermatological drug products. Pharm Res. 1999;16:1325–1330. doi: 10.1023/A:1018997520950. [PubMed] [Cross Ref]
12. Honma K, Honma M, Kohsaka M, Fukuda N. Seasonal variation in the human circadian rhythm: dissociation between sleep and temperature rhythm. Am J Physiol. 1992;262:885–991. [PubMed]
13. Gjellan K, Graffner C. Comparative dissolution studies of rectal formulations using the basket, the paddle and the flow-through methods, I: paracetamol in suppositories and soft gelatin capsules of both hydrophilic and lipophilic types. Acta Pharm Nord. 1989;1:343–354. [PubMed]
14. Gjellan K, Graffner C. Comparative dissolution studies of rectal formulations using the basket, the paddle and the flow-through methods, II: ibuprofen in suppositories of both hydrophilic and lipophilic types. Int J Pharm. 1994;112:233–240. doi: 10.1016/0378-5173(94)90359-X. [PubMed] [Cross Ref]
15. Setnikar I, Fantelli S. Liquefaction time of rectal suppositories. J Pharm Sci. 1962;51:566–571. doi: 10.1002/jps.2600510616. [PubMed] [Cross Ref]
16. Chewing gum, medicated, drug release from. In: European Pharmacopoeia 4th ed. Strasbourg, France: Directorate for the Quality of Medicines of the Council of Europe; 2002:227–228, general chapter 2.9.25.
17. Diem K, Leutner C, editors. Documenta Geigy, Scientific Tables. 7th ed. Summit, NJ: Geigy Pharmaceuticals; 1975. pp. 643–643.
18. Shameem M, Lee H, DeLuca PP. A short term (accelerated release) approach to evaluate peptide release from PLGA depot formulations. AAPS Pharm Sci. 1999;1(3) article 7. [PMC free article] [PubMed]
19. Sathe P, Tsong Y, Shah VP. In vitro dissolution profile comparison: statistics and analysis, model dependent approach. Pharm Res. 1996;13:1799–1803. doi: 10.1023/A:1016020822093. [PubMed] [Cross Ref]
20. Makino K, Arakaw M, Kondo T. Preparation and in vitro degradation properties of polylactide microcapsules. Chem Pharm Bull. 1985;33(3):1195–1201. [PubMed]
21. Burgess DJ, Hussain AS, Ingallinera TS, Chen M. Assuring quality and performance of sustained and controlled release parenterals: workshop report. AAPS Pharm Sci. 2002;4(2) article 7. [PMC free article] [PubMed]
22. Buskirk G, Gonzalez MA, Shah VP, et al. Scale-up of adhesive transdermal drug delivery systems. Pharm Res. 1997;14:848–852. doi: 10.1023/A:1012135430056. [PubMed] [Cross Ref]

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