With over 50 years of combined expertise in the areas of physical pharmacy and pharmaceutics, KPPT can assist you in providing a realistic insight into your API's quickest pathway to a successful pharmaceutical dosage form.

We have in-house capabilities to perform almost all kinds of studies including pH-solubility and stability profiles; particle size characterization and effects on solubility enhancement; excipient and vehicle compatibility screening and recommendations. Studies are designed to establish a sound and complete understanding of the entity's physico-chemical characteristics and provide a basis for efficient, rational formulation development.

What We Offer

  • Raw material and Drug Substance characterization
  • Drug-Excipient interactions and compatibility screening
  • Formulation optimization and process development/validation
  • Packaging-Container closure compatibility studies
  • Stability Studies (including ICH guidelines and specifications)
  • Specialized dosage form development including controlled release drug delivery systems, liposomes, microencapsulation and biodegradable depot implants (microspheres), topical gels and transdermal drug delivery systems, micro and nano-emulsions, sterile injectable dosage forms, and all kinds of solid oral formulations
  • Complete regulatory and documentation support for FDA regulatory submissions including CMC, NDAs and ANDAs

Our Approach

Our preformulation program is designed to generate the critical physicochemical data needed to make rational decisions about formulation strategy. Every study is executed under cGMP conditions with full documentation, enabling seamless transition to formulation development and regulatory submission.

Why Preformulation Matters

Understanding your API's intrinsic properties — solubility, stability, particle characteristics, and excipient compatibility — before committing to a formulation approach saves significant time and cost downstream. KPPT's systematic preformulation studies reduce the risk of late-stage failures and accelerate your path to clinical development.

Key Studies Performed

Solubility Profiling

pH-dependent solubility curves, solubility in biorelevant media, and saturation solubility screening across solvents and excipient systems.

Stability Assessment

Stress testing under thermal, photolytic, oxidative, and hydrolytic conditions to identify degradation pathways and stability-indicating characteristics.

Particle Characterization

Particle size distribution, morphology, surface area, and polymorphic form analysis including effects on dissolution and bioavailability.

Excipient Compatibility

Binary compatibility studies between API and candidate excipients using thermal analysis, HPLC, and spectroscopic methods.