Soft Gel Capsules & Liquid-Filled Hard Shell (LFHS) Drug Delivery System

Achieve the best outcome for your patients with Soft Gel Capsules or Liquid-Filled Hard Shell (LFHS), a practical oral solid dose delivery solution that enhances API solubility and bioavailability.

BIOAVAILABILITY SOFT GEL SOLUTIONS

Complex drug development requires enabling technologies and formulations to address the challenges of solubility, stability, bioavailability, permeability, and metabolism inherent to the drug molecule.

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Soft Gel Technology for Complex Drug Development

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. Soft Gels have the advantage to deliver the formulation in various physical states: semi-solid, liquid, gel, paste, emulsions, and microencapsulated materials.

Soft Gels are ideal for lipid-based drug delivery systems (LBDDS), self-emulsifying drug delivery systems (SEDDS), or self-micro emulsifying 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. 

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Soft Gel and Lipid-Based Drug Delivery Systems (LBDDS)

Soft Gels are ideal for lipid-based drug delivery systems (LBDDS), self-emulsifying drug delivery systems (SEDDS), or self-micro emulsifying 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. 

Pii can fill free-flowing to high viscosity materials in Soft Gels, providing a fast-turnaround service for various applications. Our end-to-end development offerings for soft gels include:

  • High potent (including Safebridge Category IV and Hormones)
  • DEA controlled substances (Schedule I-V, L1)
  • Combination of multiple APIs 
  • Cytotoxic and very low dose programs. 
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Learn More About Soft Gels

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Soft Gel and Liquid-Filled Hard Shell (LFHS)

With 25 years of experience, Pii has manufactured batch sizes as large as 1.5 million units and has worked with potency levels as low as 0.25 microgram (250 nanograms).

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. 

 Soft Gel Technology Benefits:

  • Enhanced Solubility
  • Enhanced Absorption
  • Enhanced Bioavailability
  • Enhanced API Stability
  • Delayed-Release
  • Nano-suspension

Soft Gel Differentiators

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.

  • 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
  • Various colors and sizes
  • Masking of taste and odor
  • Easy to swallow
  • Continuous process leading to seamless scale-up

 

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Pii Soft Gel Capabilities

Pii’s flexibility supports your innovative API to enhance your formulation in one location. We deliver your drug to market fast and efficiently from preclinical to commercialization. With our long history of complex drug formulation, analytical method, and process development experience, plus manufacturing capabilities, you will find a true Soft Gel partner.

Our campus includes four cGMP and FDA certified facilities, 70 manufacturing suites with all the necessary analytical and microbiological testing capabilities on-site, and four integrated aseptic filling suites delivering quality, safety, and efficiency. Experienced with small and large molecule compounds, we have special expertise in developing and manufacturing complex parenteral drugs, extended-release formulations, and non-aqueous injectable drug products.

Pii also offers Highly Potent Soft Gel Manufacturing Services. 

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