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Pharmaceutical Development

PROPHARMEX

Pharmaceutical Development

At Propharmex, pharmaceutical development is a logical, data-driven process, where the formulation strategy is the result of an based on analysis of the bio pharmaceutical properties of the drug substance, Critical Quality Attributes (CQA) and Quality Target Product Profile (QTPP) of the drug product.

  • A thorough understanding of the challenges faced during in pharmaceutical development of various drug candidates, dosage forms and delivery systems in compliance with global regulatory requirements further enhances our capabilities.
  • Expertise in working on specific challenges, such as improvement of solubility and enhancement, bio availability enhancement, release control, and targeted delivery and taste masking of unpalatable drugs.
  • Development of a robust formulation by evaluating the impact of formulation and critical material/process variables on drug product quality attributes during the lab scale development to establishing the “Design Space”.
  • Technology transfer from lab Scale to production scale and validation of unit process.
  • Time and cost being the most important aspects of the generic market, we always aim for cost effective and timely development of generic products.

Development Activities


  • Literature Search
  • Pre-formulation Studies: Drug substance characterization, Comprehensive excipient screening and selection
  • Prototype development
  • Formulation and Process Optimization
  • Stage wise documentation and technical data package
  • Submission & Post submission regulatory support.

List of Equipment’s & Instruments:


Equipment(s) Instruments in IPQC
Vibratory sifter UV / Visible spectrophotometer
High shear mixer granulator Halogen moisture balance
Fluid bed dryer / processor Tablet Hardness tester
Multi mill & Kalweka multipurpose drive pH meter
Blender(s) Weighing balance(s)
Compression machine: Multi tooling with Bilayer option. Tapped density apparatus
Tablet Auto coater & Conventional coating pan Disintegration tester
Ika Homogenizer & mixers Vertical Franz Diffusion Cells
Capsule filling machine Viscometer: QC 300 R with Peltier Device.
Blister Packing Machine & Induction sealing Dissolution apparatus I & II
Transdermal coater Modified USP II Dissolution apparatus (Enhancer cell)

Speed to market is key to success in generic pharmaceutical industry


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