Amol Dattatreya Galande

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Lupin Formulation Site
Head of the Process Development Laboratory
Amol Dattatreya Galande is a pharmaceutical postgraduate (MPharm) with around 18 years of industry experience in formulation development, quality assurance, and technical operations. He has the mandate to ensure product and process robustness of legacy powder for oral suspension and other antibiotic dosage forms in his current role as the Head of the process development laboratory at a Lupin formulation site. Amol is proficient in formulation development and regulatory ANDA submissions for challenging generic drug products. His oral solid dosage experience includes R&D, quality, and technology transfer department roles with Indian and Ireland-based manufacturing organizations. Amol recently authored a review article discussing the key developmental considerations for pediatric powder for oral suspension. He has contributed toward bringing affordable generic small molecule drug products to the US and other regulated markets.

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Article
Technical
Effect of Gum on in Vitro Dissolution of Powder for Oral Suspension

Powder for oral suspension (PfOS) bioavailability is mostly on the basis of drug absorption from the gastrointestinal tract. PfOS formulation pH, viscosity, vehicle buffer capacity, drug particle size distribution, density, and viscosity are often critical for absorption. Therefore, careful design and selection of excipients—including suspending agents—are necessary during PfOS formulation...