Process Validation of Highly Potent Antidiabetic Tablets of Voglibose 0.2 Mg

  • Lokesh K. Tijare Snehal Pharma and Surgicals Pvt. Ltd. Butibori, Nagpur
  • Lokesh T. Deshmukh Snehal Pharma and Surgicals Pvt. Ltd. Butibori, Nagpur
  • Abhinay A. Mohod Snehal Pharma and Surgicals Pvt. Ltd. Butibori, Nagpur
  • Vivek M. Bhandakkar Snehal Pharma and Surgicals Pvt. Ltd. Butibori, Nagpur
  • Santosh Hore Snehal Pharma and Surgicals Pvt. Ltd. Butibori, Nagpur
  • Nitin N. Padole Kamla Nehru College of Pharmacy, Nagpur

Abstract

Diabetes mellitus is chronic disorder which affecting number of persons worldwide, alpha glycoside inhibitors like Voglibose is a highly potent and tolerant alpha glycoside inhibitor as compare to other diabetic drugs, the main objective of this process validation is to provide documentary evidence that the manufacturing process of Voglibose Tablet IP 0.2 mg will consistently and reproducibly produce a product, which meets predetermined specifications and quality attributes. The critical process parameter was identified with the help of process capability and evaluated by challenging as per in-house specification.  Three   initial   process validation batches (T17L004, T18L003, T19A013) of same size, method, equipment & validation criteria were taken.  As per the process validation protocol critical parameter identified like sifting, dry mixing, wet granulation, drying, sifting and milling, blending &lubrication, compression at different stages and blister packing and evaluated as per process validation protocol. Conclusion: Based on evaluation of manufacturing process and analytical data it is concluded that the employed manufacturing process for Voglibose Tablet IP 0.2 mg shall be consistently& reproducibly produce a product which meeting its predetermined specification and quality attributes, hence it is considered to be validated.


 

Keywords: Voglibose 0.2 mg, Critical process parameter, Critical quality attributes, Process capability index.

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Author Biographies

Lokesh K. Tijare, Snehal Pharma and Surgicals Pvt. Ltd. Butibori, Nagpur

Snehal Pharma and Surgicals Pvt. Ltd. Butibori, Nagpur

Lokesh T. Deshmukh, Snehal Pharma and Surgicals Pvt. Ltd. Butibori, Nagpur

Snehal Pharma and Surgicals Pvt. Ltd. Butibori, Nagpur

Abhinay A. Mohod, Snehal Pharma and Surgicals Pvt. Ltd. Butibori, Nagpur

Snehal Pharma and Surgicals Pvt. Ltd. Butibori, Nagpur

Vivek M. Bhandakkar, Snehal Pharma and Surgicals Pvt. Ltd. Butibori, Nagpur

Snehal Pharma and Surgicals Pvt. Ltd. Butibori, Nagpur

Santosh Hore, Snehal Pharma and Surgicals Pvt. Ltd. Butibori, Nagpur

Snehal Pharma and Surgicals Pvt. Ltd. Butibori, Nagpur

Nitin N. Padole, Kamla Nehru College of Pharmacy, Nagpur

Kamla Nehru College of Pharmacy, Nagpur

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How to Cite
Tijare, L., Deshmukh, L., Mohod, A., Bhandakkar, V., Hore, S., & Padole, N. (2022). Process Validation of Highly Potent Antidiabetic Tablets of Voglibose 0.2 Mg. Asian Journal of Pharmaceutical Research and Development, 10(2), 90-110. https://doi.org/https://doi.org/10.22270/ajprd.v10i2.1070