Drug Res (Stuttg) 2018; 68(11): 625-630
DOI: 10.1055/a-0611-4927
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

Does GastroPlus Support Similarity and Dissimilarity Factors of in vitro-in vivo Prediction in Biowaiver Studies? A Lower Strength Amlodipine As a Model Drug

Abdel Naser Zaid
1   Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus - Palestine
,
Naser Shraim
1   Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus - Palestine
,
Asmaa Radwan
1   Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus - Palestine
,
Nidal Jaradat
1   Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus - Palestine
,
Samah Hirzallah
1   Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus - Palestine
,
Ibrahim Issa
1   Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus - Palestine
,
Aya Khraim
1   Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus - Palestine
› Author Affiliations
Further Information

Publication History

received 20 November 2017

accepted 10 April 2017

Publication Date:
23 May 2018 (online)

Preview

Abstract

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 (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.