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INSIGHTS ON SOLID DOSE MANUFACTURING

SOLID DOSE MANUFACTURING SOLUTIONS

  • Used Key International single station bench top tablet press, model: SC-2. 1.5 ton compression pressure, approximately .5" max tablet diameter, .5625" max depth of fill, manual operation, serial# JI4786.

  • A structured overview of a Phase I oral solid dose development solution promising GMP clinical batch delivery in 25 weeks from API receipt, with defined scope and flexible options.

  • Solid form screening optimizes drug properties by evaluating polymorphs, salts, and cocrystals to improve solubility, stability, and manufacturability using advanced analytics.

  • Partner with Natoli Scientific during the earliest stages. Our scientific expertise with state-of-the-art analytical capabilities is ready to take any preformulation challenge.

    Natoli scientific has an expertise of handling a wide range of APIs for the development of oral solids. We apply principles of ‘Quality by Design’ to define Critical Material Attributes (CMA), Critical Process Parameters (CPP), Critical Quality Attributes (CQA) and Quality Target Product Profiles (QTPP). Because we believe that understanding material and process as much as possible in the early life cycle of drug product development program is an insurance for further development path. Keeping your practices up to date with the ICHQ8 regulatory guidance issued by the US FDA. This is also a gate way for a smooth ride of product in the different stages of product development stages.

  • Used GlobePharma Single Station Tablet Press.