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, chemical and biopharmaceutical 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 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 (Single & two stage)
QC media

Bulk Characterization Studies

Particle size distribution and shape
Bulk density
Tapped density
Compressibility and flowability
Hygroscopicity

Solid State Characterization

Crystal habit
Crystalline or amorphous
Thermal behavior evaluation
Formulation process induced phase transformation

Stress Studies

Hydrolytic
pH
Oxidative
Thermal
Photo-stability

Drug Excipient Compatibility

Mixtures of API with excipients (binary or ternary) of different categories

Drug Developability Assessment

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

Why Aurigene Preformulation Studies services?

Experience with various characterization techniques

US FDA -inspected labs with advanced instrumentation

Understanding of various regulatory and Pharmacopeial requirements

Other Services

Clinical and Commercial Packaging Services

Clinical Supplies and Commercial Manufacturing

CMC and Regulatory Support

Drug Excipient Compatibility Studies

Drug Product Characterization Studies and Testing Services

Drug Product Development

Early Phase Formulation Development

Formulation Studies

Pharmaceutical Stability Studies

Virtual Tour

Hyderabad R and D Center

Bangalore R and D Center

Pharmaceutical Analytical Services

Polymorph Screening

ADME/DMPK Services

Drug Formulation Services

In vivo Pharmacology

Medicinal Chemistry

Microbiology Testing

Peptide Synthesis

Development & Kilo Lab

Toxicology Studies

Connect with our scientific experts for your drug discovery, development, and manufacturing needs

We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.

Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.

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