Sunovion Pharmaceuticals Inc.

Patheon Softgels Inc.

Mucodel Pharma LLC

Nova Thin Film Pharmaceuticals LLC

Monosol Rx, LLC

Madhu Hariharan

Scott David Barnhart

Anthony John Giovinazzo

Qi Fang

Michael Clinton Koons

Jordan Dubow

Thierry Bilbault

Josh Heflin

Richard C Fuisz

Joseph M Fuisz

An oral soluble film contains at least one active agent. Alternatively, a multi-layered film includes a plurality of layers, at least one at least one of the plurality of layers being an oral soluble film layer containing at least one active agent. The oral soluble film may be made, e.g., by a method comprising providing a well of a predetermined size; depositing a film forming composition in the well; metering a predetermined amount of an active agent composition in the well separately from the film forming composition, the active agent composition being different than the film forming composition, the film forming composition and the active agent composition forming a single layer in the well; and drying the single layer in the well to form the oral soluble film containing the at least one active agent.

Method and system for manufacturing and oral soluble films and oral soluble films made by thereby

Methods and pharmaceutical unit dosage forms for treating Parkinson's disease in a subject (e.g., an 'off' episode in a subject having Parkinson's disease) are described. The pharmaceutical unit dosage forms are films having a first portion including particles containing an acid addition salt of apomorphine and a second portion containing a pH neutralizing agent. The pharmaceutical unit dosage forms can be flexible and have toughness greater than 100 g&#xd7;mm. The methods can involve administering to a subject having Parkinson's disease a therapeutic dose sufficient to produce an apomorphine plasma concentrate of at least 2.64 ng/mL within 45 minutes after the administration. The subject may be identified as having low uptake, medium uptake, or high uptake of apomorphine administered via oral mucosa.

Methods of treating Parkinson's disease by administration of apomorphine to an oral mucosa

A kit for mucosally administering a metastable supersaturated solution of a pharmaceutical active agent to a human patient includes a first compartment comprising a first composition comprising a pharmaceutical active agent in solution at or below equilibrium solubility, and a second composition comprising an acidic buffer. The first and second compartments maintain separation of the first and second compositions during storage, and allow for mixing of the first and second compositions to form a supersaturated solution above equilibrium solubility of the pharmaceutical active agent for immediate mucosal administration to a human patient. In one embodiment, the second composition comprises an acidic buffer and the supersaturated solution has an acidic pH. Alternatively, the second composition comprises a basic buffer and the supersaturated solution has a basic pH.

Chemically stable compositions of a pharmaceutical active agent in a multi- chambered delivery system for mucosal delivery

Methods of treating parkinson's disease by administration of apomorphine to an oral mucosa

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.

An oromucosally absorbable liquid composition for administration to a human patient comprises one liquid containing a pH-sensitive pharmaceutically active together with one or more optional suitable pharmaceutical excipients in a first compartment; and a second liquid at pH greater than 5 containing a buffer or alkaline components together with one or more optional suitable pharmaceutical excipients in a second distinct compartment; the first and second compartments maintaining separation of the first and second liquids during storage and allowing for mixing of the two liquids to form an oromucosally absorbable composition at the point of use.

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Greensboro, NC, United States of America

Madhu Hariharan