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US 11,077,114 B2Granted
Stabilized formulations of CNS compounds
AssigneeSupernus Pharmaceuticals, Inc.
InventorsRong-Kun Chang, Michael L. Vieira, Likan Liang, Padmanabh P. Bhatt, Austin B. Huang, Sachin V. Patel
Life of this patent
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Abstract
Formulations of molindone having superior stability and methods of administering same are provided. The formulations may be immediate, modified, or otherwise delayed release formulations of molindone.
Claims28
A pharmaceutical formulation comprising molindone as a single active pharmaceutical ingredient and having:
- (a) a modified-release formulation comprising a matrix of a homogeneous admixture of:
- (i) molindone,
- (ii) at least one release controlling polymer, wherein the release controlling polymer consists of one or more non-pH-dependent polymers selected from the group consisting of hydroxypropyl cellulose, hypromellose (hydroxypropyl methyl cellulose), methyl cellulose, polyethylene oxide, acacia, carbomer homopolymer type A NF;
- carbomer homopolymer type B NF, hydroxyethyl cellulose, carrageenan, tragacanth, xanthan gum, povidone, alginic acid and salts thereof, polyvinyl alcohol, carboxymethylcellulose;
- ethylcellulose, cellulose acetate, cellulose acetate butyrate, poly(ethyl acrylate-co-methyl methacrylate) ethyl acrylate methyl methacrylate copolymer, poly (ethyl acrylate-co-methyl methacrylate-cotrimethylammonioethyl methacrylate chloride), polyvinyl acetate, and cellulose acetate propionate, and
- (iii) at least one stabilizer selected from the group consisting of acidifying agents and hydrophobizing agents;
- wherein the total amount of water content in the formulation is not more than 5% by weight of the formulation and, optionally,
- (b) an additional formulation comprising molindone in an immediate release, extended release, or delayed release formulation;
- and
- (c) a coating or a membrane comprising a water insoluble, pharmaceutically acceptable polymer.
7 more elements
A pharmaceutical formulation comprising molindone as a single active pharmaceutical ingredient and having:
- (a) a modified-release formulation comprising:
- (i) a matrix of molindone and at least one stabilizer selected from the group consisting of acidifying agents and hydrophobizing agents, and optionally at least one release controlling polymer;
- and
- (ii) an extended release (XR) coating surrounding the matrix comprising at least one release controlling polymer consisting of one or more non-pH-dependent polymers selected from the group consisting of hydroxypropyl cellulose, hypromellose (hydroxypropyl methyl cellulose), methyl cellulose, polyethylene oxide, acacia, carbomer homopolymer type A NF;
- carbomer homopolymer type B NF, hydroxyethyl cellulose, carrageenan, tragacanth, xanthan gum, povidone, alginic acid and salts thereof, polyvinyl alcohol, carboxymethylcellulose;
- ethylcellulose, cellulose acetate, cellulose acetate butyrate, poly(ethyl acrylate-co-methyl methacrylate) ethyl acrylate methyl methacrylate copolymer, poly (ethyl acrylate-co-methyl methacrylate-cotrimethylammonioethyl methacrylate chloride), polyvinyl acetate, and cellulose acetate propionate;
- wherein the total amount of water content in the formulation is not more than 5% by weight of the formulation and, optionally,
- (b) an additional formulation comprising molindone in an immediate release, extended release, or delayed release formulation.
5 more elements
Dependencies are inferred from the claim text.