Acceptable analytical practices for dissolution testing of poorly soluble compounds

Pharmaceutical Technology

Volumn 28, Issue 12, 2004, Pages 56-65

  Brown, Cynthia K ^a   Chokshi, Hitesh P ^b   Nickerson, Beverly ^c   Reed, Robert A ^d   Rohrs, Brian R ^c   Shah, Pankaj A ^e  

^a ELI LILLY AND COMPANY   (United States)

^b HOFFMANN LA ROCHE INC   (United States)

^c PFIZER INC   (United States)

^d MERCK RESEARCH LABORATORIES   (United States)

^e BRISTOL MYERS SQUIBB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DISSOLUTION TESTING; POORLY SOLUBLE COMPOUNDS;

DISSOLUTION; DRUG PRODUCTS; TECHNICAL PRESENTATIONS; TESTING;

SOLUBILITY;

CETRIMIDE; CREMOPHOR; CYCLODEXTRIN; DODECYL SULFATE SODIUM; PHOSPHATIDYLCHOLINE; POLYSORBATE; TETRADECYL SULFATE SODIUM; TWEEN; TYLOXAPOL;

ANALYTIC METHOD; CONFERENCE PAPER; DRUG FORMULATION; DRUG MANUFACTURE; DRUG PENETRATION; DRUG RELEASE; DRUG SOLUBILITY; VALIDATION PROCESS;

EID: 10344257263     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (12)

1. R.A. Reed, "A Biopharmaceutical Classification System Approach to In Vitro Dissolution Method Development," presented at the PhRMA Acceptable Analytical Practices Workshop, Washington, DC, 23-25 September 2003.
2. B.R. Rohrs, "In Vitro Dissolution Testing of Poorly Soluble Compounds: Impact of Formulation Design," presented at the PhRMA Acceptable Analytical Practices Workshop, Washington, DC, 23-25 September 2003.
3. Food and Drug Administration, Guidance for Industry: Immediate Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (FDA, Rockville, MD, November 1995).
4. G.L. Amidon et al., "A Theoretical Basis for Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product Dissolution and In Vivo Bioavailability," Pharm. Res., 12 (3), 413-420 (1995).
5. Food and Drug Administration, Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms (FDA, Rockville, MD, August 1997).
6. Food and Drug Administration, Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (FDA, Rockville, MD, August 2000).
7. General Chapters 〈711〉, "Dissolution" and 〈724〉 "Drug Release," in The United States Pharmacopeia 27-National Formulary 22 (United States Pharmacopeial Convention, Inc., Rockville, MD, 2004), pp. 2303-2304 and 2305-2312.
8. S. Boudreau et al., "Acceptable Analytical Practice for Phase Dependent Method Validation," Pharm. Technol., 28 (11) 54-66 (2004).
9. J. Wyvratt, "Acceptable Analytical Practice for Setting Acceptance Criteria," pending publication.
10. Food and Drug Administration, Guidance for Industry: Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (FDA, Rockville, MD, September 1997).
11. International Conference on Harmonization, Topic Q6A, "Specifications for New Drug Substances and Products : Chemical Substances," Step 4, (ICH, Geneva, Switzerland, October 1999).
12. P.N Zannikos et al., "Spectrophotometric Prediction of the Dissolution Rate of Carbamazepine Tablets," Pharm. Res. 8 (8), 974-978 (1991).