Patheon Softgels Inc.

Banner Life Sciences LLC

Banner Pharmacaps, Inc.

Qi Fang

Justin R Hughey

Jason M Vaughn

YinYan Zhao

Yunhua Hu

Martin Piest

Madhu Hariharan

Josh Heflin

Henricus M G M Van Duijnhoven

Gregory L Dietel

Don A Archibald

Linus G Fonkwe

Henricus Van Duijnhoven

Charles S Casault

Henricus Mgm Van Duijnhoven

Described herein are soft capsules and enteric soft capsules comprising cationic Type A gelatin and acid insoluble enteric polymers. In particular, the compositions and methods for manufacturing all-natural enteric soft capsules comprising Type A gelatin and matrix fills are described. In one embodiment, the enteric soft capsules comprise active ingredients such as non-steroidal anti-inflammatory drugs (NSAIDs). In another embodiment, the enteric soft capsule comprises matrix fills of omega-3 fatty acids.

All-natural enteric soft capsules

Described herein are topical, non-systemic, slow releasing oral pharmaceutical compositions, methods for making the same, and methods for treating subjects in need thereof with such compositions. In particular, the oral composition provides topical, non-systemic administration of one or more active pharmaceutical ingredients to the oral cavity and upper gastrointestinal track, including the esophagus. In one embodiment, the pharmaceutical composition provides topical corticosteroids to the esophagus and oral cavity.

Soft lozenge compositions

Described herein are oral pharmaceutical compositions suitable for chewing, sucking, or buccal dissolution comprising non-systemic corticosteroid soft lozenges, methods for making the same, and methods for treating subjects in need thereof with such lozenges. In particular, the oral composition provides topical, non-systemic administration of one or more active pharmaceutical ingredients to the oral cavity and upper gastrointestinal track, including the esophagus. In one embodiment, the oral pharmaceutical compositions comprise chewable, suckable, or buccally-dissolvable soft lozenges for the treatment of esophageal lesions. The soft lozenges provide topical, non-systemic delivery of corticosteroids to the esophagus and oral cavity.

Described herein are pharmaceutical enteric soft capsules that do not contain gelatin as a film-forming polymer. In particular, compositions and methods for manufacturing enteric soft capsules comprising carrageenans as film forming polymers are disclosed.

Non-gelatin enteric soft capsules

Enteric soft capsules containing carrageenans as the film-forming polymer have been developed. The enteric soft capsules comprise iota carrageenan and kappa carrageenan, methacrylic acid copolymers, modifeid starch fillers, plasticizers, water, and other excipients. Such enteric soft capsules are stable at pH 1.2 for at least 2 hours and dissolve at pH 6.8 within about 30 minutes. Methods for manufacturing enteric soft capsules comprising carrageenans are also exemplified.

Soft lozenges comprising corticosteroids

Non-systemic topical compositions comprising corticosteroids

A film-forming composition comprising a hydrocolloid, a plasticizer, and water is described. A process and apparatus for producing a non-gelatin film comprising a hydrocolloid, a plasticizer, and water is also disclosed. The process includes combining at least one non-gelatin hydrocolloid, water, and at least one plasticizer into a substantially homogeneous film-forming composition comprising at least about 40 percent water by weight. A substantial portion of the water is then extracted from the film-forming composition to form a dried portion having a water content of less than or equal to about 25 percent by weight. The dried portion of the film-forming composition is formed into a film. A film produced according to the process preferably has a tensile strength at rupture of at least about 0.4 N/mn, and a percent elongation of at least about 50 percent at rupture at room temperature. An apparatus for performing the process is also described, as well oral dosage forms encapsulated or enrobed in the produced film.

Non-gelatin film and method and apparatus for producing same

Growing community of inventors

Oak Ridge, NC, United States of America

Qi Fang