The drug delivery solution of choice – bringing better treatments to market faster
As innovators of softgel technology, Catalent RP Scherer softgel, brings more than 75 years of development expertise and manufacturing experience to the full spectrum of drug delivery. Softgel is the drug delivery solution of choice that solves complex formulation, solubility, bioavailability, and development challenges, bringing more molecules to market faster.
With the increased use of softgel technology in medicines, vitamin and mineral supplements, and cosmetics, we have met the challenge with specialized global manufacturing facilities and innovative technological enhancements, such as our enteric-coated softgels, chewable softgels, and our proprietary, plant-derived offering, OptiShell™ capsules.
Backed by strong scientific expertise and deep regulatory experience, our softgel services – from preformulation to clinical supply to manufacturing - can help optimize your product performance and minimize your time to market through a proven dosage form with a track record of commercial success.
Catalent RP Scherer Softgel Benefits
Softgel drug delivery technology has numerous advantages that can help bring your challenging compounds to market.
- Pharmacological
- Improve the bioavailability of your poorly water-soluble and poorly permeable compounds
- Improve the solubility for your BCS (Biopharmaceutical Classification system) II compounds
- Improve solubility and permeability for your BCS III/IV compounds
- Enhance dose uniformity of your potent compounds and minimize patient-to-patient variability
- Generate a faster onset of action, reducing API dose, minimizing side effects, and improving your overall treatment performance
- Reduce development time through a proven dosage form with a strong track record of commercial success
- Manufacturing
- Get specialized handling and manufacturing for your hormones, cytotoxics, potent and difficult APIs
- Differentiate your brand with various color, shape, size and printing options
- Protect your product from counterfeiting and tampering
- Benefit from our continuous planning process across multiple manufacturing sites to meet demand fluctuations
- Meet your timely product launches with reliable commercial supply
- Benefit from our Foreign Trade Zone that may provide a substantial duty savings on imported APIs
- Rely on our top-class, regulatory compliance in our global network of cGMP, FDA, EMA, and locally accredited facilities
Valuable Product Differentiation
We offer industry-leading softgel technology solutions that can be uniquely customized for a variety of markets.
- Softgel technologies offer a whole range of delivery solutions to improve the overall value of your treatments:
- Controlled-release technologies
- Enteric coating enables delayed-release of the active ingredient with targeted absorption
- Vegicaps® capsules
- Proprietary non-gelatin plant-derived shell, an optimal solution for semi-solid compounds and APIs with higher melting points
- Suppositories and vaginal ovules
- Highly-suited drug delivery solution for vaginal and/or rectal creams and ointments with improved patient compliance
- Chewables
- Ideal for pediatric, adolescent, and geriatric markets, accommodating wide range of formulations
- Unlimited shapes, sizes, and colors to differentiate your product and meet with your tailored specifications
- In-line printing that provides protection from brand counterfeiting
How It Is Made
- Process
- Softgel capsules are formed, filled, and sealed in a single operation. The gelatin is melted with water and plasticizer to form a molten gel mass. This is cooled on the encapsulation machine into two ribbons which will form the outer coating, or shell of the capsule. The liquid, suspension, or semi-solid (fill) containing the API enters the top of the encapsulation machine as two ribbons of gelatinous material are fed into each side. The fill is encapsulated by the gelatin ribbons, which yield a formed capsule. After the softgel capsules are formed, they are spread on drying trays and placed in drying tunnels.
- Timeline
- Once production for a specific product begins, the manufacturing process normally proceeds 24 hours per day until the lot is completed. This typically results in a manufacturing environment that operates around the clock, 7 days a week.
- Additional Innovation
- In-line gel ribbon printing, a Catalent innovation, is a great differentiating optional feature we offer to have your product name, dosage, or logo printed directly on the wet gelatin ribbons. This can benefit your differentiation, regulatory, and compliance requirements.
Catalent RP Scherer Softgel Services
We have a long track record of customizing successful programs involving our proprietary advanced technologies:
- Preformulation and feasibility studies
- Solubility screening of NCEs
- Softgel capsule fill formulation development
- Small-scale lab encapsulation for providing early stability data and final formulation selection
- Shell development
- An extensive gelatin shell library, which enables us to offer a wide variety of gelatin options for a range of products
- A large range of shell formula and compatibility possibilities
- Extensive technical support in softgel capsule product development
- Self-emulsifying/microemulsion vehicle systems
- Unique formulations leading to potentially patentable line extensions
- Reliable supply from clinical phases to commercial manufacturing
- Contingency planning and quality assurance via our large global network
Catalent RP Scherer Softgel Facilities
Our deep formulation expertise supported by a global infrastructure of cGMP, FDA, EMA and locally accredited softgel facilities will provide a catalyst to your success by tailoring a unique drug delivery solution to bring your product faster to market.
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