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Preformulation Studies

Preformulation Studies

Effective pre-formulation studies for the most appropriate delivery method for accelerating the drug to the clinic.

As an integrated part of our formulation services, the preformulation studies, cover the assessment of a wide range of physical and chemical properties, which are critical to establishing the ideal formulation and delivery method for your lead candidates. The knowledge of various parameters based on regulatory and client-specific requirements is essential to formulate a high-quality drug product to satisfy your scientific requirements.

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Physicochemical Characterization

  • Dissociation constant (pka)
  • Partition coefficient (log P)
  • Distribution coefficient (log D)
  • Molar absorption coefficient

Solubility and Stability Studies

  • Aqueous and Non-aqueous
  • pH buffers
  • Solubilizers and excipients
  • Bio-relevant media (FaSSIF, FeSSIF and SGF)

Dissolution Studies

  • Intrinsic
  • Bio-relevant (mono or biphasic)
  • QC media

Bulk Characterization Studies

  • Particle size distribution and shape
  • Bulk density
  • Tapped density
  • Compressibility and flowability
  • Hygroscopicity (dynamic vapor sorption)

Solid State Characterization

  • Crystal habit
  • Crystalline or amorphous
  • Anhydrous/hydrate/solvate
  • Polymorph identification
  • Thermal behavior evaluation (melting temperature and phase transition)

Stability

  • ICH-compliant stability studies
  • Intermediate
  • Accelerated
  • Photostability

Stress Studies

  • Hydrolytic
  • pH
  • Photo
  • Oxidative
  • Thermal

Drug Excipient Compatibility

  • Mixtures of API with excipients (binary or ternary) of different categories including solutions /solvents used for processing

Drug Developability Assessment

  • BCS and DCS classifications
  • Developability assessment to identify suitable formulation technology

Salt or Co-crystal and Polymorph Selection

  • Evaluation and identification of the most suitable form to increase drug product performance
  • Process-induced phase transformation

Why Aurigene Pharmaceutical Services?

Experience with various characterization techniques

US FDA -inspected labs with advanced instrumentation

Understanding of various regulatory and pharmacopeial requirements

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Frequently asked questions

What is formulation research and development?

Formulation development is a part of the drug product development process where the drug substance is combined with suitable excipients and processed to produce stable drug products such as tablets, capsules, injectables, topical cream/gel.

What is the role of formulations in pharmaceutics?

The formulation in pharmaceuticals is a process where the drug substance/API is mixed with an excipient to form a final drug product by considering the particle size, pH, stability, polymorphism, and solubility. It helps to decide the most optimal delivery mode such as oral, parenteral, pulmonary, nasal, topical, ophthalmic or rectal.

What does drug formulation mean?

Drug formulation is the process where a drug substance/ Active Pharmaceutical Ingredient (API) is converted into a final human consumable oral, parenteral, pulmonary, nasal, topical, ophthalmic, or rectal formulation to treat diseases.

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