Effective Oral Drug Products
Selecting the right cGMP Contract Manufacturer to produce your oral solid dosage form is an important decision. CordenPharma is your partner of choice for Oral Solid Dose (OSD) formulation development and manufacturing.
We can accompany you for the entire lifecycle of your products, from early phase development, clinical supplies, late stage registration and validation, to commercial manufacturing and packaging. Additionally, we can handle APIs with OELs down to the picogram per cubic meter level.
OSD Drug Product Development and Manufacturing
CordenPharma has three state-of-the-art facilities focused on OSD formulation development and manufacturing. From small-scale development and early clinical phase quantities to commercialization, our capabilities include a wide range of services such as formulation development, finished dose manufacturing, and packaging that supports new chemical entities, reformulations, and generics:
- Formulation development, clinical supply and commercial manufacturing
- Conventional processing technologies
- Blending
- Roller compaction
- High shear and fluid bed granulation, aqueous and organic solvents
- Tablet compression and coating (aesthetic and enteric)
- Encapsulation
- Solutions for APIs with bioavailability challenges
- Spray drying
- Hot melt extrusion
- Micronization
- Nanomilling
- Lipid-based formulations (SEDDS / SMEDDS)
- Immediate and modified release formulations
- Powders, granules, pellets
- Coated and uncoated tablets, minitablets
- Hard gelatin and HPMC capsules
- Blister, bottle, and sachet packaging
Drug products for pediatric use:
- Minitablets
- Granules and pellets
- Dry syrups
- Oral Disintegrating Tablets (ODT)
- Small chewable tablets or effervescent tablets
- Small standard tablets and capsules (low dose)
- Taste masking
- Rectal dosage forms
CordenPharma can develop and manufacture from hundreds of grams to commercial-scale manufacturing. Our expertise in oral solid dose manufacturing, along with a long-standing reputation of quality and reliability in all regulated markets including Japan, make us your OSD partner of choice.
Early Phase Development and Manufacturing Services
CordenPharma’s Drug Product Innovation Centre of Excellence offers early-phase formulation development and manufacturing services for oral solid dose (OSD) drug products, including bioavailability enhancement technologies. In collaboration with our Solid State Centre of Excellence, we provide integrated API and drug product services, ensuring a continuous feedback loop between identifying the best API form required for a drug product formulation that provides sufficient absorption / solubility, stability, and processability.
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First-in-Human (FIH) OSD Capabilities
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Prototype Development
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Accelerated Stability
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FIH cGMP Manufacturing
First-in-Human (FIH) OSD Capabilities
Getting a product into FIH clinical Phase I studies in a flexible, fast, and efficient manner is important. We offer an initial developability assessment that includes API profiling and technology selection (conventional, bioavailability enhancing) followed by a screening study (excipients, polymers, etc.), phase appropriate formulation development, and prototype preparation. Utilizing the Accelerated Stability Assessment Program (ASAP) for stability, we are able to identify the best prototype to manufacture and advance your product into FIH quickly.
- Integrated DS and DP development
- Developability assessment
- Screening studies
- Formulation challenges
- GLP supply
- FIH supply
- ASAP and accelerated stability programs
- Analytical support
Prototype Development
During the developability assessment, a risk assessment is performed utilizing available data including dose, hygroscopicity, solubility, solid state properties, particle size distribution, and permeability. A DCS risk factor is applied and is based on the dosage range.
An in vivo risk factor is applied if the intended dosage is medium or high, which is based on the relative fraction absorbed in systemic circulation after oral administration. Our early-phase formulation development team uses these two risk factors to suggest which type of prototype formulation strategy should be targeted during initial development.
Accelerated Stability
Are you interested in predicting the stability of your API or drug product in less than 4 weeks? ASAP stability programs are a time-saving approach that can project the degradation rate of your product at room temperature conditions from just a select number of accelerated / stressed high temperature testing samples.
Benefits of an ASAP stability study include:
- De-risk decisions
- Predict chemical stability, shelf-life
- Support dosage form and packaging selection(s)
- Reduce costs
- Shorten development timelines
- 20-35 samples, 6-8 conditions, 2-3 weeks
- Results are accepted by most regulatory authorities
- No formal ICH study is required for FIH
FIH cGMP Manufacturing
After the preclinical investigation is complete, the selected prototype(s) will be developed to the final dosage form intended for clinical supply.
One challenge in FIH studies may be in identifying the appropriate dosage range. Some of the dosage forms outlined below are flexible with regards to final dosage strength. Capsules can easily be filled with different volumes or quantities of API, powder / granules, pellets, or minitablets.
Our encapsulation technology can ensure that different dosage strengths are available “on demand” during the clinical study. In parallel, phase-appropriate analytical methods will be qualified to ensure they are suitable for use in releasing all materials.
FIH dosage forms include:
- API- / Powder- / Granules- / Pellets-in-Capsule
- API- / Powder- / Granules-in-Bottle (for reconstitution)
- Liquids / Solutions / Suspensions
- Tablets / Minitablets
OSD Packaging
CordenPharma is an internationally approved expert in contract manufacturing and packaging of many different dosage forms. Various primary and secondary packaging technologies are available across our network of facilities throughout Europe and the US including bottles, blisters, and sachets.
Want to find out more?
Get in touch with our team of experts to explore bespoke end-to-end CDMO support of your complete drug lifecycle
at any scale.