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Pharmaceutical Development


Pharmaceutical Development

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

  • Thorough understanding in pharmaceutical development of various drug candidates, dosage forms and delivery systems in compliance with global regulatory requirements.
  • Experience in working on specific challenges, such as improvement of solubility and bio availability, release control targeted delivery and taste masking
  • 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.
  • Experience and expertise in addressing regulatory deficiencies for different regulatory agencies.
  • Time and cost being the most important aspects of generic market, we 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 multippurpose 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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