# A comparative study on vildagliptin brand and its generic equivalents using dissolution test as quality control measure tool

**Authors:** Ghadah H. Altoum, Fouza K. AL-Enazi, Mubarl M. Abudahash, Reem A. AL-Fadhli, Naif Alenzi

PMC · DOI: 10.1038/s41598-024-52674-4 · Scientific Reports · 2024-02-01

## TL;DR

This study compares the quality of brand and generic vildagliptin tablets using dissolution tests to ensure they meet quality standards.

## Contribution

The study introduces an in vitro protocol for evaluating the quality of newly released generic vildagliptin drugs.

## Key findings

- All tested vildagliptin samples showed dissolution behavior similar to the branded drug.
- Dissolution of all samples reached standard levels within 15 minutes.
- Similarity factors confirmed the tested generics are comparable to the reference drug.

## Abstract

Market drugs including brand or generic with poor quality, don’t meet the acceptable standard guidelines. Vildagliptin is an important antidiabetic drugs used in monotherapy or in combinations protocols for treatment of diabetes mellites. The main goal of the current study is to assess the pharmaceutical equivalence of two marketed generics of vildagliptin 50 mg tablets compared to the branded product (Galvus 50 mg). The in vitro dissolution test was used as a quality control tool to obtain the dissolution profile of vildagliptin compared to the reference drug. The results revealed that all tested samples showed dissolution behavior like standard drug. Whole samples dissolution reached after 15 min in accordance with the standard. According to the similarity factors records, tested vildagliptin samples showed a comparable dissolution to the reference drug. The current work presents an in vitro protocol for quality evaluation of recently released generic drugs.

## Linked entities

- **Chemicals:** vildagliptin (PubChem CID 6918537)
- **Diseases:** diabetes mellitus (MONDO:0005015)

## Full-text entities

- **Genes:** DPP4 (dipeptidyl peptidase 4) [NCBI Gene 1803] {aka ADABP, ADCP2, CD26, DPPIV, TP103}
- **Diseases:** diabetes mellites (MESH:D003920), type 2 diabetes mellitus (MESH:D003924)
- **Chemicals:** BCS-I (-), water (MESH:D014867), Galvus (MESH:D000077597), HCl (MESH:D006851), acetonitrile (MESH:C032159), potassium phosphate (MESH:C013216), phosphoric acid (MESH:C030242)
- **Species:** Homo sapiens (human, species) [taxon 9606]

## Full text

_Full body text omitted from this summary view._ Fetch the complete paper as Markdown: https://tomesphere.com/paper/PMC10834493/full.md

## Figures

2 figures with captions in the complete paper: https://tomesphere.com/paper/PMC10834493/full.md

## References

22 references — full list in the complete paper: https://tomesphere.com/paper/PMC10834493/full.md

---
Source: https://tomesphere.com/paper/PMC10834493