Abstract: Disclosed in certain embodiments is a softgel composition comprising a fill material encapsulated in a shell composition. The shell composition having a non-animal derived gelling agent and a water soluble polymer. The shell composition completely dissolving in less than 30 minutes when subject to a dissolution with a USP Apparatus II with paddies at 75 RPM in 900 ml of 0.1N HCL and deionized water at 37 degrees C.

Abstract: Disclosed herein are improved collagenase-containing formulations and methods of preparing the same. The collagenase-containing formulations comprise a collagenase, about 30 mM to about 240 mM of a disaccharide, about 50 mM to about 800 mM of mannitol, and about 6 mM to about 10 mM of a Tris-HCl. Lyophilized and reconstituted formulations are also provided.

Abstract: Softgel capsules comprise a fill material and a shell composition, wherein the fill composition includes bisacodyl and the shell composition includes a film forming material and an enteric polymer. The softgel capsules further include 5 parts by weight of bisacodyl based on 100 parts by weight of the fill material. A method for producing the softgel capsule using a gel conversion is also provided.

Abstract: Delayed release softgel capsules including a fill material and a pH dependent shell composition. In one embodiments, the pH dependent shell composition includes gelatin, pectin, dextrose, and a combination of glycerin and sorbitol or sorbitol sorbitan solution. The delayed release nature of the capsules meets enteric disintegration criteria and/or inhibits premature release of the fill material in acidic pHs (such as pH of from any of about 1.2 to about 6).

Abstract: Delayed release softgel capsules including a fill material and a pH dependent shell composition. In one embodiments, the pH dependent shell composition includes gelatin, pectin, dextrose, and from about 0.5 wt % to about 10 wt % of a synthetic polymer. In an alternative embodiment, the pH dependent shell composition includes gelatin, pectin, dextrose, and an organic acid. The delayed release nature of the capsules inhibits premature release of the fill material in acidic pHs (such as pH of from any of about 1.2 to about 6).

Abstract: Described are modified release softgel capsules including a pH dependent shell composition that encapsulated a controlled release fill composition, methods of preparation thereof, and methods of use thereof. The pH dependent shell composition may be characterized in that the delayed release nature of the capsules may be achieved without a separate pH dependent coating or added conventional pH dependent polymers. The softgels provide a dual controlled release platform which facilitates delivery of the active agent to a target location in the gastrointestinal tract and a controlled release profile of the active agent at said target location in the gastrointestinal tract.

Abstract: A controlled release fill composition for use in soft or hard capsules, soft- or hard-shell capsules encapsulating controlled release fill compositions, a method of producing a softgel capsule with a controlled release fill composition encapsulated in the soft gel capsule shell. The controlled release fill composition includes an active pharmaceutical ingredient; polyethylene oxide having a number average molecule weight of from 0.05 M daltons to 15 M daltons; and at least one of water or a hydrophilic carrier having a number average molecule weight of from 200 daltons to 5000 daltons. Also, in the controlled release fill composition either the polyethylene oxide is present in an amount of at least 21.5 wt. %, based on a total weight of the controlled release fill composition, or the hydrophilic carrier is present in an amount up to 65 wt. %, based on a total weight of the controlled release fill composition.

Abstract: Delayed release softgel capsules comprise a fill material and a pH dependent shell composition, characterized in that the delayed release nature of the capsules may be achieved without a pH dependent coating or added conventional pH dependent polymers. The delayed release softgel capsules described herein are particularly suitable for initiating release of the active agent in a target location in the colon environment.

Abstract: Disclosed in certain embodiments is a delayed release softgel capsules comprise a fill material that is encapsulated in a pH dependent shell composition, the pH dependent shell composition including pectin and gellan gum. Also disclosed are methods of preparing any of the delayed release softgel capsules described herein and methods of use thereof.

Abstract: Delayed release softgel capsules comprise a fill material and a pH dependent shell composition, characterized in that the delayed release nature of the capsules may be achieved without a pH dependent coating or added conventional pH dependent polymers.

Abstract: Disclosed herein are improved collagenase-containing formulations and methods of preparing the same. The collagenase-containing formulations comprise a collagenase, about 30 mM to about 240 mM of a disaccharide, about 50 mM to about 800 mM of mannitol, and about 6 mM to about 10 mM of a Tris-HCl. Lyophilized and reconstituted formulations are also provided.

Abstract: Disclosed herein are methods, systems, and kits for determining the total amount of a coating polymer in a dosage form. The coating polymer may be a polydisperse polymer having a plurality of molecular weights. The instant disclosure enables to accurately, reliably, and efficiently determine the total amount of a polydisperse polymer in a dosage form that includes one or more other constituents that have a molecular weight range that overlap with at least some of the polydisperse polymer's molecular weight.

Abstract: A hydrophilic vehicle-based dual controlled-release matrix system, suitable for encapsulation in hard or soft capsules, has been developed. The matrix is in the form of a solution or a suspension, which allows for easier formulation of low dose compounds. The matrix includes two rate controlling barriers for the controlled release of one or more pharmaceutically active agents. The primary rate controlling barrier includes a hydrophilic vehicle. The primary rate controlling barrier can further comprise one or more solvents which are miscible with the hydrophilic vehicle. The secondary rate controlling barrier includes a hydrogel-forming polymeric material dissolved or dispersed in the hydrophilic vehicle. The presence of the hydrogel-forming polymeric material makes extraction of the drug from the dosage form more difficult. This feature could be beneficial in preventing or minimizing the misuse of dosage forms which contain drugs which are prone to abuse.

Abstract: A lipophilic vehicle-based dual controlled-release matrix, suitable for encapsulation in hard or soft capsules, has been developed. The matrix is in the form of a suspension, which allows for easier formulation of low dose compounds and/or compounds which are moisture sensitive. The matrix includes two rate controlling barriers for the controlled release of one or more pharmaceutically active agents. The primary rate controlling barrier includes a relatively lipophilic oily vehicle. The primary rate controlling barrier may further comprise or more excipients, dissolved in the lipophilic vehicle, which themselves have rate controlling properties. The secondary rate controlling barrier is a hydrogel-forming polymeric material which is dispersed in the primary rate controlling barrier. As the primary rate controlling barrier breaks down, the pharmaceutically active agent is slowly released and the surrounding aqueous media begins to percolate into the polymer matrix.

Abstract: A hydrophilic vehicle-based dual controlled-release matrix system, suitable for encapsulation in hard or soft capsules, has been developed. The matrix is in the form of a solution or a suspension, which allows for easier formulation of low dose compounds. The matrix includes two rate controlling barriers for the controlled release of one or more pharmaceutically active agents. The primary rate controlling barrier includes a hydrophilic vehicle, such as a combination of high molecular weight and low molecular weight polyethylene glycols. The primary rate controlling barrier can further comprise one or more solvents which are miscible with the hydrophilic vehicle. The secondary rate controlling barrier includes a hydrogel-forming polymeric material dissolved or dispersed in the hydrophilic vehicle. Formation of the hydrogel can occur during drying when water migrates from the shell into the fill or upon dissolution of the capsule shell as the surrounding aqueous media comes into contact with the matrix.

Abstract: A lipophilic vehicle-based dual controlled-release matrix, suitable for encapsulation in hard or soft capsules, has been developed. The matrix is in the form of a suspension, which allows for easier formulation of low dose compounds and/or compounds which are moisture sensitive. The matrix includes two rate controlling barriers for the controlled release of one or more pharmaceutically active agents. The primary rate controlling barrier includes a relatively lipophilic oily vehicle. The primary rate controlling barrier may further comprise or more excipients, dissolved in the lipophilic vehicle, which themselves have rate controlling properties. The secondary rate controlling barrier is a hydrogel-forming polymeric material which is dispersed in the primary rate controlling barrier. As the primary rate controlling barrier breaks down, the pharmaceutically active agent is slowly released and the surrounding, aqueous media begins to percolate into the polymer matrix.

Abstract: A non-blooming plasticizer composition and methods of using the composition are described herein. The composition is a mixture of sorbitol and sorbitan wherein the ratio of sorbitan and sorbitol is between about 0.40 and about 1.2 by weight, more preferably from about 0.45-0.50 to about 0.70 by weight, wherein the composition contains less than 20% of other dextrose hydrolytic degradation products. The non-blooming plasticizer compositions can be mixed, alone or in combination with other shell additives, with gelatin or non-gelatin materials to prepare soft capsules for the delivery of pharmaceutical, nutritional and personal care products, such as bath oils, shampoos and conditioners, and skin lotions.