Dissolution test development for complex veterinary dosage forms: Oral boluses
نویسندگان
چکیده
منابع مشابه
"In vitro" dissolution tests for solid oral dosage forms.
©2010 Particle Sciences, Inc. All rights reserved. the drug substance and involves two steps: dissolution and absorption (or permeability). Understanding the multi-step dissolution process is essential to proper in vitro method development. Dissolution is the process of extracting the API out of the dosage form solid-state matrix into solution within the gastrointestinal tract. Absorption is th...
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Development of an appropriate dissolution method for quality control purposes requires consideration of many factors and a balance of different needs. The method is typically distinctive to each drug product because of the unique characteristics of the active ingredient, the formulation, and the manufacturing process. The method development and selection process remains subjective due to the po...
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This paper describes a fully-automated system (AUTO DISS((R))) for the determination of active ingredient release of solid oral dosage forms according to the paddle method of the US Pharmacopoeia (USP) and European Pharmacopoeia.Twenty batches can be tested continuously, with the six individuals (tablets, capsules etc.) of one batch being examined synchronous. The components of the AUTO DISS((R...
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A dissolution test for in vitro evaluation of tablet dosage forms containing 10 mg of rupatadine was developed and validated by RP-LC. A discriminatory dissolution method was established using apparatus paddle at a stirring rate of 50 rpm with 900 mL of deaerated 0.01 M hydrochloric acid. The proposed method was validated yielding acceptable results for the parameters evaluated, and was applied...
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Obtaining a biowaiver for topical drugs used in veterinary species faces many of the same challenges associated with human topicals. However, the skin of domestic animals varies anatomically and biochemically and experimental approaches to assess bioequivalence (BE) in veterinary species have challenges that are not often encountered with human skin. This is especially the situation with locall...
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ژورنال
عنوان ژورنال: AAPS PharmSci
سال: 2002
ISSN: 1522-1059
DOI: 10.1208/ps040435