OSD Formulation evaluation
Evaluating prototype formulations is important in determining the most appropriate drug product formulation to align with the desired absorption profile in humans.
Corealis initiates OSD formulation development projects by covering a wide range of formulations and manufacturing processes. These include: in vitro (e.g., dissolution profile, appearance, assays, related substances, crystal state, friability, hardness); and in vivo (PK results from an animal model) results. Based on findings, the most appropriate drug product is selected.
Corealis provides comprehensive formulation development services to bring clients’ innovations to the clinic quickly with phase-appropriate pharmaceutical oral solid dosage forms (e.g., tablets, capsules, pellets, granules) for:
- New Active Pharmaceutical Ingredients (API)
- Off patent APIs for 505(b)(2) filings.
The team offers development expertise for a diverse array of oral drug product formulations that are adapted to each clinical phase, the therapeutic applications, and the targeted patient population:
- API-in-a bottle, API-in-a-capsule
- Immediate Release
- Modified Release (e.g., delayed, sustained, multi-modal, gastro-retentive)
- Sublingual
- Bioavailability enhancement
- Anti-drug abuse/alcohol dose dumping formulations
- Effervescent
- Powders, granules, and minitablets to be dissolved, suspended, or mixed in food substrates (e.g., apple sauce, yogurt)
- Fixed dose combination of two to three APIs
- Reformulation of drug products
- Drug products for new therapeutic applications or different patient populations (e.g., pediatric, swallowing impairment)
- Controlled substances
- Highly potent API (HPAPI) up to OEB 3
- Matching placebos
Corealis utilizes small-scale, advanced equipment for efficient and scalable formulation and manufacturing processes:
- Tabletting
- Encapsulation (Pure API, powders, tablets, granules, multi-particulates and combinations)
- Dry granulation (RC)
- Wet granulation (FBG, high and low shear)
- Amorphous enabling technologies (spray-drying (aqueous/solvents), coprecipitate dispersion, and hot melt extrusion)
- Melt granulation
- Extrusion and spheronization
- Coating aesthetic or functional (FB and pan)
- Packaging (bottle, blister, sachet) and labeling
Working with Corealis
Corealis experts uses derived data to recommend the best protocols and methods for each step.
A scientific and collaborative approach with clients helps develop the most appropriate drug product for the targeted therapeutic application from which product and manufacturing specifications are established.
With a team of experts, a cooperative methodology, and a steadfast commitment to efficiency, Corealis stands as a reliable and trusted partner.
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Our formulation experts can provide a free assessment of your API, plus recommendations to reduce risk and boost market appeal.
Our formulation services
Contact Corealis
Corealis’ experts are ready to answer any queries about the company’s oral solid dose offering, including its development and manufacturing capabilities.