Softgels

 

For more than ten years, Pii has specialized in softgel formulation development and GMP manufacturing. Our softgel experience includes the manufacture of commercial products as well as multiple feasibility and dosage form development programs. Pii can support your softgel development project from bench scale to commercial manufacturing.

 

The softgel encapsulation process consists of two concurrent manufacturing processes: gel mass manufacturing and fill compounding. During encapsulation, fill is injected between two formulated gel ribbons as counter-rotating dies. The dies cut out the ribbons into the desired two dimensional shape, and form a seal around the outside, while a pump delivers a precise dose of fill material. The resulting capsule is heated to facilitate the sealing process. Following encapsulation, the softgels are dried, polished and printed.

 

A Proven Solution for Challenging Compounds

Softgels have historically been used to solve formulation challenges, to improve clinical/patient performance of compounds, to provide safe handling for hormonal, potent and cytotoxic drugs, and to provide important market differentiation.

 

An ideal delivery vehicle for compounds with poor solubility, low melting point, and susceptible to oxidation or UV degradation, softgels are a proven delivery technology for challenging APIs.

 

Softgel are a versatile dosage form that has applications for several drugs, in particular those with poor oral bioavailability. The ability to formulate the API in solution, suspension, self-emulsifying or micro emulsion vehicle systems, enables the development of poorly soluble compounds with improved bioavailability.

 

The outer layer of the softgel can be enteric coated for taste/odor masking or the development of a

controlled release formulation.  The hermetic seal of capsules ensures the API is protected from air and ensures protection from oxidation. Additionally, gelatin shells can be formulated to be opaque therefore protecting the API from ultraviolet light.

 

Market research has found that consumers respond more positively to softgels. They perceive the dosage form to be easier to swallow, have a faster onset of activity and offer better taste and odor masking. Formulating in lipid-based liquid or semi-solid formats is also an excellent way to reformulate existing drugs in an effort to extend patent protection or create a new line extensions for OTC drugs. Additionally, capsules can be developed in signature colors, shapes and surface printing to provide greater product and brand identity.

 

Soft Gel Equipment & Capabilities

From bench to launch, Pii has the experience and capabilities to support your softgel development project. Our softgel capabilities include:

 

• Feasibility studies and prototype formulations
• Pilot scale and CTM production
• Gel shell design studies to optimize finished product performance
• Commercial manufacturing
• Analytical services to support product development

 

Pii has the ability to develop individualized colors and/or two-toned shells for easy product recognition and dosage distinction.  Pii can also print product identification information on the capsule shell.  Our softgel equipment includes:

 

• Bochang- 4”die
• Bochang- 10”die
• Gwalo Capsule Polishers (36”& 48”)

 

Benefits & Advantages

• Clinical advantages - Rapid onset of action, dosage accurancy and improved patient compliance
• Improved bioavailability for poorly soluble compounds
• Sustained release development
• Longer shelf-life, product security and stability
• Life cycle management / Intellectual property positioning
• Working with Pii offers the advantage of ten years of softgel development and market launch experience.