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; Naser Shraim; Asmaa Radwan; Nidal Jaradat; Samah Hirzallah; Ibrahim Issa; Aya Khraim

doi:10.1055/a-0611-4927

Drug Research, Table of Contents

Drug Res (Stuttg) 2018; 68(11): 625-630
DOI: 10.1055/a-0611-4927

Original Article

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

Authors

Abdel Naser Zaid

¹Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus - Palestine
Naser Shraim

¹Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus - Palestine
Asmaa Radwan

¹Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus - Palestine
Nidal Jaradat

¹Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus - Palestine
Samah Hirzallah

¹Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus - Palestine
Ibrahim Issa

¹Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus - Palestine
Aya Khraim

¹Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus - Palestine

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.

Key words

Amlodipine - Biowaiver - In Silico - dissolution - Pharmacokinetics

Full Text

References

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