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Dosage form Development

Our formulation laboratories are fully equipped to work on new chemical entities (NCE’s), generics, specialty products, reformulation and life cycle extension of existing molecules. We have the expertise for developing robust formulations for molecules that have solubility, bioavailability and stability concerns. We utilize process analytical technologies (PAT) in developing quality and cost effective products within the committed timelines.

We have a fully compliant cGMP facility for scale-up and manufacture of clinical supplies.
Preformulation Development
Formulation Development
Analytical R&D
   
Preformulation Development
Profiling of physicochemical properties and biopharmaceutical assessment supporting drug candidate selection
Salt form screening to generate a solid salt form with desirable crystalline, stability, hygroscopic, and solubility characteristics
Monitor/ Assure adequate solubility and stability of formulations used for in-vitro/in- vivo efficacy and toxicology screens
Monitor/Assure proper physical forms used for PK and efficacy studies
Active pharmaceutical ingredient (API) testing and characterization
pH solubility profile, partition-coefficient determination, stability,permeability and physical form challenges to guide formulation development
Excipient compatibility studies
Formulation Development
Formulation development of a wide variety of dosage forms
Identify appropriate excipients to provide acceptable stability and bioavailability
Develop dosage forms that improve patient compliance
Identify composition and process parameters that facilitate manufacturing
Develop dosage forms that meet global stability requirements
Scale up and production of cGMP batches
Process validation and technology transfer
Utilize approaches that will allow global filings

Capabilities:

Solids: Tablets, capsules, granules and powders
Liquids: Oral solutions, syrups and suspensions
Semi-solids: Creams and ointments
Parenterals: Small volume, sterile powders

Technologies:

  • Immediate release
  • Sustained release (matrix and multiparticulate)
  • Delayed release
  • Hot melt filling of capsules.
  • Aqueous and organic film coating.
  • Active coating of tablets, granules, beads and soft and hard gelatin capsules
  • Lyophilized powders

Potent Molecules:

Aizant has established the environmental, health and safety systems in its facility to develop highly potent compounds.

Aizant has implemented the following controls to handle potent compounds.

  • Engineering
  • Personal safety
  • Administrative
Analytical R&D
Analytical research and development (AR&D) works closely with chemical process, product development and quality assurance teams. AR&D ensures the stability and quality of clinical supplies and to provide the necessary documents for global regulatory submissions. AR&D operates in a cGLP and cGMP compliant environment to develop validated methods for the physical, chemical and microbiological characterization of the drug substance, the drug product, excipients and packaging components. AR&D also provides support for the testing and release of pre-clinical and clinical supplies. AR&D is also responsible for analyzing the stability samples of development and marketed drug products.

Drug substance characterization

  • Identification, potency, moisture, residual solvents and chromatographic purity and degradation products
  • Solid state characterization (amorphous, crystalline, hydrate, etc)
  • Comparability studies to bridge synthesis changes
  • Reference Standards

Formulation characterization

  • Identification, assay, moisture content, related substances, chiral purity, dissolution
  • Dose/content uniformity, blend uniformity, stratified sampling and other in-process methods
  • Preservatives, antioxidants and other minor components
  • Polymorphic purity
  • Forced degradation studies
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