• search
Country
CAPTCHA This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Preformulation Studies and Services

Preformulation Studies and Services

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.

Speak to our experts

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

Virtual Tour

 

Contact Us

Country
CAPTCHA This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
resourceMainImage

JUNE 28, 2022

Neoantigen Specific T cells For Cancer Immunotherapy

Neoantigen specific T cells for cellular cancer immunotherapy An effective anti-tumor immune response in human is marked by presence of T cells reactive against neoantigens. Neoantigens are HLA-bound unique peptides arise from tumor-specific somatic mutations. Neoantigens are highly immunogenic because they are not present in normal tissues and hence...

Read More
resourceMainImage

Building successful long-term partnerships with CDMOs from early drug discovery through commercialization

Building successful long-term partnerships with CDMOs from early drug discovery through commercialization Maximizing efficiency in drug research, development, and manufacturing is crucial for turning new innovations into therapeutic and financial benefits. Over the past couple of decades, pharmaceutical companies have increasingly turned to contr...

Read More
resourceMainImage

Technology meets sustainability - How a complex API development process goes green

We are always looking for ways to enhance the sustainability of our products and services. Our team successfully developed a scalable manufacturing process for the API product of one of our Biotech clients using eco-friendly manufacturing technologies. Read the case study to learn more. ...

Read More

Alternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug

2023

Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...

Read More
View All

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.

×

You are about to leave Aurigene Pharmaceutical Services and affiliates website. Aurigene Pharmaceutical Services assumes no responsibility for the information presented on the external website or any further links from such sites. These links are presented to you only as a convenience, and the inclusion of any link does not imply endorsement by Aurigene Pharmaceutical Services.

If you wish to continue to this external website, click Proceed.

ProceedBack