Soft Gelatin Capsules

PII’s soft gelatin technology can be used for liquid and suspension fills encapsulated with a compatible gelatin shell formulation for the following:

Insoluble compounds
Highly potent compounds
Oxygen sensitive materials
Taste masking products
Topical applications

Gelatin Shell Design
PII has expertise in gelatin shell formulation for optimal finished product performance.

Capsule Shape, Color and Printing
In addition to common oval, oblong and round shapes, alternative sizes and shapes such as tubes or twist-offs for topical formulations or suppositories are available. Individualized colors and two-toned shells can also be developed for product recognition and dosage distinction. PII can print product identification information on the capsule shell.

Small-Scale Production
For both development and cGMP supplies, PII’s soft gelatin machine can encapsulate small-scale prototype fill formulations of approximately 500 ml of liquid, or 400 capsules. For smaller quantities, soft gelatin capsule air fills can be hand filled to assess stability and excipient compatibility and to conduct animal and/or Phase I trials.

Clinical Trial Material (CTM)
PII can scale-up prototype formulations and manufacture Clinical Trial Materials (CTM) in batch sizes up to 200,000 capsules at a rate of 5,000 to 25,000 capsules per hour.

Commercial Manufacturing
PII has the capability to manufacture commercial supplies with an annual capacity of 300 million capsules per year. Batch sizes of up to 1.5 million capsules can be manufactured.

Pharmaceutics International, Inc.
10819 Gilroy Road, Hunt Valley, MD 21031
Phone: 410 584-0001 Fax: 410 584-0007
www.pharm-int.com
Mission Statement: To deliver a quality dosage form development service which meets all of our customers’ needs in a timely fashion