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Comparison of WHO and US FDA biowaiver dissolution test conditions using bioequivalent doxycycline hyclate drug products.
J Pharm Pharmacol. 2009 Mar; 61(3):331-7.JP

Abstract

OBJECTIVES

The dissolution characteristics of immediate-release doxycycline hyclate products with certified in-vivo bioequivalence to the innovator product were tested with a view to possible application of biowaiver-based approval.

METHODS

Five products were tested using US Pharmacopeia Apparatus 2: Antodox 100 mg hard gelatin capsules, Doxycyclin AL 100 T tablets, Doxycyclin-ratiopharm 100 soft gelatin capsules, Doxycyclin STADA 100 mg tablets and Doxy-Wolff 100 mg tablets. Three compendial buffers were used as dissolution media: simulated gastric fluid without pepsin, pH 1.2, acetate buffer, pH 4.5, and simulated intestinal fluid without pancreatin, pH 6.8. Results were obtained at two paddle speeds recommended for biowaiver applications: 75 rpm (World Health Organization; WHO) and 50 rpm (US Food and Drug Administration; US FDA).

KEY FINDINGS

The results for the tablets and hard gelatin capsules indicate that a paddle speed of 75 rpm is more representative than 50 rpm, since 75 rpm generates dissolution profiles corresponding more closely to the in-vivo profiles than those at 50 rpm. For evaluating soft gelatin capsule formulations with lipid fill, both US FDA and WHO methods were found to be over-discriminating.

CONCLUSIONS

Bioequivalence of immediate-release doxycycline hyclate tablets and hard gelatin capsules, but not soft gelatin capsules, can be evaluated in vitro using the biowaiver dissolution test conditions specified by the WHO.

Authors+Show Affiliations

Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany.No affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

19222905

Citation

Strauch, Stefanie, et al. "Comparison of WHO and US FDA Biowaiver Dissolution Test Conditions Using Bioequivalent Doxycycline Hyclate Drug Products." The Journal of Pharmacy and Pharmacology, vol. 61, no. 3, 2009, pp. 331-7.
Strauch S, Jantratid E, Dressman JB. Comparison of WHO and US FDA biowaiver dissolution test conditions using bioequivalent doxycycline hyclate drug products. J Pharm Pharmacol. 2009;61(3):331-7.
Strauch, S., Jantratid, E., & Dressman, J. B. (2009). Comparison of WHO and US FDA biowaiver dissolution test conditions using bioequivalent doxycycline hyclate drug products. The Journal of Pharmacy and Pharmacology, 61(3), 331-7. https://doi.org/10.1211/jpp/61.03.0007
Strauch S, Jantratid E, Dressman JB. Comparison of WHO and US FDA Biowaiver Dissolution Test Conditions Using Bioequivalent Doxycycline Hyclate Drug Products. J Pharm Pharmacol. 2009;61(3):331-7. PubMed PMID: 19222905.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of WHO and US FDA biowaiver dissolution test conditions using bioequivalent doxycycline hyclate drug products. AU - Strauch,Stefanie, AU - Jantratid,Ekarat, AU - Dressman,Jennifer B, PY - 2009/2/19/entrez PY - 2009/2/19/pubmed PY - 2009/4/18/medline SP - 331 EP - 7 JF - The Journal of pharmacy and pharmacology JO - J Pharm Pharmacol VL - 61 IS - 3 N2 - OBJECTIVES: The dissolution characteristics of immediate-release doxycycline hyclate products with certified in-vivo bioequivalence to the innovator product were tested with a view to possible application of biowaiver-based approval. METHODS: Five products were tested using US Pharmacopeia Apparatus 2: Antodox 100 mg hard gelatin capsules, Doxycyclin AL 100 T tablets, Doxycyclin-ratiopharm 100 soft gelatin capsules, Doxycyclin STADA 100 mg tablets and Doxy-Wolff 100 mg tablets. Three compendial buffers were used as dissolution media: simulated gastric fluid without pepsin, pH 1.2, acetate buffer, pH 4.5, and simulated intestinal fluid without pancreatin, pH 6.8. Results were obtained at two paddle speeds recommended for biowaiver applications: 75 rpm (World Health Organization; WHO) and 50 rpm (US Food and Drug Administration; US FDA). KEY FINDINGS: The results for the tablets and hard gelatin capsules indicate that a paddle speed of 75 rpm is more representative than 50 rpm, since 75 rpm generates dissolution profiles corresponding more closely to the in-vivo profiles than those at 50 rpm. For evaluating soft gelatin capsule formulations with lipid fill, both US FDA and WHO methods were found to be over-discriminating. CONCLUSIONS: Bioequivalence of immediate-release doxycycline hyclate tablets and hard gelatin capsules, but not soft gelatin capsules, can be evaluated in vitro using the biowaiver dissolution test conditions specified by the WHO. SN - 0022-3573 UR - https://www.unboundmedicine.com/medline/citation/19222905/Comparison_of_WHO_and_US_FDA_biowaiver_dissolution_test_conditions_using_bioequivalent_doxycycline_hyclate_drug_products_ L2 - https://doi.org/10.1211/jpp/61.03.0007 DB - PRIME DP - Unbound Medicine ER -