Pharmaceutical formulation development ensures effective drug delivery with optimized formulation’s characteristics for appropriate drug product bioavailability, and also creates Standard processing requirements. With a difficult conversion rate from preclinical to clinical success and approval, formulation development and a complete understanding of the form and structure
of the drug substance and drug product is critical for a good formulation development.
Arrowsandsgroup offers streamlined, cost-effective and high-quality formulation development packages. for different types of formulations, including dry powders for inhalation, spray coated granules, and other advanced formulations, providing requiring cutting edge input for problem solving, and expert personnel or specific laboratory equipments.
- Preformulation screening: including identifying suitable formulation parameters (pH, ionic strength, protein concentration, excipients, etc.) with high throughput formulation approaches based on design of experiment.
- Analytical development: identifying degradation products; selecting stability-indicating methods;
- Preclinical formulation development: liquid, frozen or freeze-dried formulations (e.g., for toxicological studies) and others (Oral- Solution, suspensions and microdose capsules, Parenterals- aqueous liquid injectables, non-aqueous injectables, lyophilized injectables, ophthalmic and otic solutions and nasal solutions)
- Transfer of formulations to the external CMO and formulation development for clinical phase I and II
- Clinical formulations (Oral solids, soft gelatin capsules and parenterals-aqueous liquid injectables, non-aqueous injectables, lyophilized injectables, ophthalmic and otic solutions and nasal solutions)