Sunovion Pharmaceuticals Inc.

Cynapsus Therapeutics, Inc.

Marc L De Somer

Anthony John Giovinazzo

Nathan Bryson

David Bruce Hedden

Nathan John Bryson

Disclosed are sublingual formulations of apomorphine, and methods of treating Parkinson's disease therewith. The sublingual formulations are films or strips having a first portion comprising apomorphine particles comprising an acid addition salt of apomorphine and a second portion comprising a pH neutralizing agent.

Sublingual apomorphine

Disclosed are methods of preparing a pharmaceutical composition that is a mucoadhesive film by: (i) combining a film-forming mucoadhesive polymer, apomorphine particles containing an acid addition salt of apomorphine, and a solvent to form a mixture; and (ii) pouring the mixture onto a surface and evaporating some of the solvent to form an intermediate film including the apomorphine particles; where the method further includes contacting or impregnating the intermediate film or mixture with a pH neutralizing agent to produce the mucoadhesive film containing the apomorphine particles and the pH neutralizing agent.

Disclosed are sublingual formulations of apomorphine in unit dosage form formulated for sublingual administration, where the unit dosage form is a mucoadhesive film containing a pH neutralizing agent and apomorphine particles containing an acid addition salt of apomorphine, and where the mucoadhesive film is formed by the steps of: (i) combining a film-forming mucoadhesive polymer, apomorphine particles comprising an acid addition salt of apomorphine, and a solvent to form a mixture; and (ii) pouring the mixture onto a surface and evaporating some of the solvent to form a first film comprising the apomorphine particles, where the steps further include contacting or impregnating the first film or mixture with a pH neutralizing agent to produce the mucoadhesive film containing the apomorphine particles and the pH neutralizing agent.

The invention features mucoadhesive sublingual films containing a pH neutralizing agent and apomorphine particles containing an acid addition salt of apomorphine. The pH neutralizing agent in these films can be sodium phosphate monobasic, sodium phosphate dibasic, sodium phosphate tribasic, potassium phosphate monobasic, potassium phosphate dibasic, potassium phosphate tribasic, or a mixture thereof.

Disclosed are methods of treating Parkinson's disease by (i) providing a pharmaceutical composition in unit dosage form that is a film having a first portion including apomorphine particles containing an acid addition salt of apomorphine and a second portion containing a pH neutralizing agent, where the film contains the acid addition salt of apomorphine in an amount effective to treat Parkinson's disease, and (ii) administering the film by placing the film sublingually in the mouth of the subject and contacting sublingual mucosal tissue with the film.

The invention features methods involving the use of sublingual film formulations of apomorphine for treating Parkinson's disease. The methods involve providing the sublingual film formulation and administering the sublingual film formulation sublingually in the mouth of a subject by contacting sublingual mucosal tissue with the film.

The invention features sublingual formulations of apomorphine that is a mucoadhesive polymer film or a strip having a first portion including an acid addition salt of apomorphine and a second portion including a pH neutralizing agent, and methods of treating Parkinson's disease, sexual dysfunction, and depressive disorders by administering sublingually the film or strip.

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Winchester, MA, United States of America

Marc L De Somer