Background Many generic pharmaceutical products are currently available on the market place worldwide. Recently, there is a growing concern on the quality and efficacy of generic products. However, health care professionals such as physicians and pharmacists are in difficult situations to choose among alternatives.

Purpose The aim of this study is to assess the effectiveness of the in silicotechnique (Gastro Plus^®) in the biowaiver study and whether similarity and dissimilarity factors (f ₂ and f ₁ respectively) are effective in this regard.

Method The concentration of amlodipine in the sample was calculated by comparing the absorbance of the sample with that of a previously prepared amlodipine standard solution using validated HPLC method. The dissolution profile for each product (brand and generics) was constructed. The similarity (f₂) and dissimilarity (f ₁) factors were calculated for the generic product according to equation 1 and 2. GastroPlus™ software (version 9.0, Simulations Plus Inc., Lancaster, CA, USA) was used to predict the absorption profiles of amlodipine from the generic product Amlovasc^® and the reference Norvasc^®.

Conclusion These results may provide a rationale for the interchangeability between the RLD and generic version based on in vitro release profiles in silico technique especially in a lower strength dose drug.

Title

Drug Research

Publisher

Georg Thieme Verlag

Publisher Country

United Kingdom

Indexing

Scopus

Impact Factor

None

Publication Type

Prtinted only

Volume

--

Year

2018

Pages

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