Soft Gel Capsules & Liquid-Filled Hard Shell (LFHS) Manufacturing Solutions
Soft Gel Capsules are beneficial for complex drug manufacturing & development. In addition to the flexible production opportunities, soft gels are beneficial to improve: solubility, stability, bioavailability, permeability, and metabolism inherent to the drug molecule.
SOFT GEL MANUFACTURING IMMEDIATE AVAILABILITY
Our Soft Gel Capsule Manufacturing team specializes in complex molecules, NCE’s, NDA’s, with expertise in handling both potent and non-potent programs. With over 25 years of experience, Pii has manufactured batch sizes up to 1.5 million units and has worked with potency levels as low as 0.25 microgram (250 nanograms).
Soft Gel Machine Capabilities
- Up to 1.5 Million Capsules Per Batch
- Compound Bulk up to 700 Liters
- High Potent & Complex Softgels
Complex Soft Gel Manufacturing Capabilities
- Orphan Drugs
- High Potent (Safebridge Category IV & Hormones)
- Low Dose Programs
- Multiple APIs
- DEA-Controlled Substances (Schedule I-V & L1)
Talk to a Pii Scientist
Talk to a Pii Scientist
cGMP & FDA-Certified CDMO
for Soft Gel Manufacturing
The Pii team is here to work with you. Pii is a cGMP-certified CDMO that is designed to be a one stop shop for your soft gel capsule manufacturing needs. As specialists in complex soft gel production, we have designed our teams and facilities accordingly.
Project Management & Personal Relationship:
Our analytics, quality assurance, project management, and regulatory support team meets twice a week to review all projects. This helps reduce redundancy and improve the safety & speed of your soft gel production. This also allows us to have streamlined logistics, reducing corporate red tape and bringing your product to patients safer & faster.
Facilities Designed to Reduce Supply Chain Risks:
Our campus includes four cGMP-certified and FDA-certified facilities, 70 manufacturing suites with all the necessary analytical and microbiological testing capabilities on-site.
All of Pii’s soft gel manufacturing machines & production teams are located under one roof. For complex soft gel capsules (ex: Highly Potent, program with multiple API’s, DEA Schedule I-V, Hormones, and more), we know how important it is to ensure controls are in place for safe handling and that the program maintains its efficacy and purity. By having our team and production in one area, we are able to ensure robust processing and handling with our experienced team of soft gel experts.
Your Product - Your Patent:
Pii does not promote any of its owns proprietary technology. Pii’s technical experience and scientists work towards establishing a formulation and process that allows the product to deliver its full potential. This means that all proprietary designs and formulations are yours to keep.
Improve Solubility, Stability, Bioavailability & Permeability with Soft Gel Capsules
Soft Gels are versatile in size, shape, and color and are easier to swallow, making them ideal for pediatric and geriatric populations. The delivery base is a soft gelatin shell surrounding a liquid or semi-solid center that can mask odors and unpleasant tastes. The outer shell is hermetically sealed, protecting from light and oxygen, making it an ideal cost-effect delivery method.
Soft Gel Capsule Benefits:
- Enhanced Solubility
- Enhanced Absorption
- Enhanced Bioavailability
- Enhanced API Stability
- Extended Release
- Delayed Release
- Nano Suspension
Bioavailability Challenges? Pii is Here to Help
Soft Gel Capsules are Ideal for LBDDS, SEDDS, & SMEDDS Delivery Systems
Soft gel Capsules are ideal for lipid-based drug delivery systems (LBDDS), self-emulsifying drug delivery systems (SEDDS), or self-microemulsifying drug delivery systems (SMEDDS).
LBDDS is specific for formulations containing a dissolved or suspended drug in lipid excipients. LBDDS can be simple or complex formulations and provide the increased solubilization and the absorption needed, resulting in enhanced bioavailability.
Talk to a Pii Scientist
Soft Gels with Multiple APIs, High Potent, & Hormones
Soft gel Capsules are a proven delivery for challenging molecules because of its effectiveness in increasing the solubility and permeability of drugs and it offers accurate and precise dosing, even at the microgram level.
- Delivery of non-aqueous solution/suspensions and solubility enhancement (e.g. SMEDDS, lipid-based systems, nanosuspension)
- Ideal for products with multiple APIs (combination products)
- Delivery of very low doses of API with precision and accuracy
- Protection against oxygen and light for oxygen and photosensitive APIs
- Readily dissolve in vivo, providing faster onset of action
- Manufacturing process minimizes dust generation
- Continuous process leading to seamless scale-up
- Various colors and sizes
- Masking of taste and odor
- Easy to swallow
Liquid-Filled Hard Shell (LFHS)
Pii’s Liquid-Filled Hard Shell (LFHS) technology includes a more defined development process for compounds that require higher temperature fill (more than 45 degrees.) Pii has a wealth of experience in formulating and testing a variety of complex materials and is ready for your IP challenges.