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 silico technique (Gastro Plus^®) in the biowaiver study and whether similarity and dissimilarity factors (f₂ and f₁ 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 (f₁) 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.

العنوان

Drug research

الناشر

Thieme

بلد الناشر

ألمانيا

Indexing

Scopus

معامل التأثير

None

نوع المنشور

Both (Printed and Online)

المجلد

68

السنة

2018

الصفحات

1-6