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Preclinical & clinical formulation

Preclinical & clinical formulation

Developing challenging formulations for new chemical entities (NCEs)

Sai Life Sciences offers development, pre-clinical and clinical formulation services for your lead compound. We have the expertise to develop formulations applicable for your pre-clinical & Phase 1 studies for peroral, topical and parenteral administration. Let us find the best formulation for your candidate, focusing on the desired bioavailability and optimal stability of your drug product. When paired with our drug substance production services, drug product can be delivered just in time following approval of your IND.

Solubility Enhancement Approaches

  • We utilize following solubilization techniques to improve solubility.
  • Use of buffers (pH adjustment)
  • Use of Co-Solvent and surfactants
  • Inclusion complex (e.g., cyclodextrin based systems)
  • Use of triglycerides (Lipid Based Screening)
  • Micronization
  • Lyophilization

Clinical formulation

We offer services for clinical supplies up to Phase 1 for oral solid dosage forms. Our facility has been approved by local FDA for cGMP manufacturing. Oral solid dosage form capabilities include batch sizes up to 10 kg with packaging in bottles or blister packs, and delivery to the clinical investigation sites. For Phase 2 and larger quantity needs, we collaborate with external partners, having proven our expertise to transfer the technology developed to sites identified by client across geographies.

Formulation strategies

  • Simple Solution
  • Suspension or nano-suspension
  • GLP tox formulation
  • Spray dried Dispersion
  • Capsules
  • Micro-emulsion or nano-emulsion
  • Lyophilization
  • Topical gels, creams, ointments, and lotions
  • High-Potency Parenteral Prototype Product Development

Pharmaceutical formulation development

Prototype formulation and process is designed with the help of pre-formulation data. Sai has formulation development lab equipped with different equipment’s to develop all dosage forms and validated stability chambers to conduct stability study as per ICH requirement. At Sai we have vast & rich expertise of working across multiple technologies with increasing complexity to develop variety of dosage forms.

1) Liquid Oral Dosage Forms:
• Solutions and suspensions
• Emulsions and Micro-emulsions
• Powder for oral solution or suspension

2) Solid Oral Dosage form
• Conventional tablets: Immediate release
• Modified release tablets: Matrix/Reservoir based formulations, MUPs, functionally coated
• Oral Disintegrating Tablets: Drug encapsulated solid porous Microcapsules, Formulations for faster action, Formulations for improving bioavailability

3) Capsules
• FIH formulations – drug in capsule
• Formulated capsules – powder blend/granules in capsules
• Modified release capsules- beads or mini tablets in capsules
• Liquid filled hard gelatin capsules

4) Parenteral dosage Forms:
• Ready-to-use liquid formulation
• Lyophilized formulations

5) Topical Semi-Solids Dosage Forms:
• Ointments, creams and gels
• Drug Formulations for cutaneous & percutaneous delivery
• High drug loaded topical formulations
• Controlled / Sustained release topical formulations
• Enhanced lipid-based penetration systems.

7) Packaging Development
• Selection of materials
• Selection of configuration
• Labeling

8) Analytical Testing:

Analytical method development / qualification.
For Critical Quality Attributes
• Identification
• Assay (Active/ preservative/ antioxidant etc.)
• Impurities (Organic / Inorganic / Genotoxic etc.)
• Residual Solvents
• Dissolution (Release / Discriminating)
• Water content /LOD

Analytical method validation (phase-appropriate) as per ICH / USP / EMA etc. guidelines
• Specificity
• System suitability testing
• Detection limit
• Quantitation limit
• Linearity
• Accuracy
• Precision
• Range
• Solution stability
• Robustness

Analytical method transfer- for critical quality attributes with direct /indirect process.
• Assay (Active/ preservative/ antioxidant etc.)
• Impurities (Organic / Inorganic / Genotoxic etc.)
• Residual Solvents
• Dissolution (Release)

Process development scale-up

Sai Life Sciences has state of the art labs for formulation development as well as Scale up of the product up to a scale range of 0.5 kg to 10 kg and supply Clinical samples for solid oral dosage forms for Phase I study.
For further phases we can collaborate with external partners and the teams have expertise to transfer the technology developed to sites identified by client across geographies.

Principles of Quality by Design (QbD)

QbD techniques are applied on process and formulation variables (Excipients), to get desired drug product quality which covers:
-CMA (Drug substance and excipients)
-Risk Mitigation
-Control Strategy

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