Biowaiver Monograph for Gabapentin Immediate Release Capsules Solid Oral Dosage Forms

Supervisor

Dr. Nasr Shraim

Abstract

Background:Multisource (generics)  drugs must demonstrate similar and efficacy in order to be interchangeable with each other also with an innovator product and the similarities usually explained by the bioequivalence study(in vivo study), because of the difficulty of this study which ensures the high cost, time-consuming and exposes healthy  volunteer to a risk. The World Health Organization (WHO) has called for the drug exemption from in vivo equivalence testing by granting biowaivers which based mainly on Biopharmaceutical Classification System (BCS) and the decision whether the two pharmaceutical products are equivalent (biowaived) adopted mainly on a dissolution test.

Aims: The present monograph reviews Literature and experimental data in order to the decision to allow a biowaiver procedure for the approval of immediate release (IR) solid oral dosage forms containing Gabapentin as the active pharmaceutical ingredient(API)

Methods: BCS basics were evaluated in order to determine the BCS classification of Gabapentin that includes the following: solubility and permeability data which collected and evaluated from literature data, also dissolution experiments were conducted on the brand product and its generic versions in Beit Jala Pharmaceutical company. Then the consequence of granting a biowaiver decision for products containing Gabapentin as an API  were evaluated.

Results: The collected data for permeability and solubility revealed that Gabapentin has a "low permeability"  and "high solubility" criteria according to the BCS criteria. Both innovator and generic products which contain Gabapentin showed a "very rapid dissolution " since their release was more than 85% in less than 15 min.

Conclusion: Our study concluded that IR solid oral dosage forms of Gabapentin would be reasonably safe to grant biowaiver and our result suggest that Gabapentin can be a candidate for waiver of an in vivo bioequivalence study. And thus in this way we can reduce cost, time and unnecessary exposure of healthy volunteers to the risk and finally to market the quality generic products.