Oral dispersible films
Inventors
Borges, Ana Filipa Silva • Silva, Branca Margarida Almeida • Coelho, Jorge Fernando Jordao • Silva, Claudia Sousa • Simoes, Sergio Paulo
Assignees
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Publication Number
US-9603935-B2
Publication Date
2017-03-28
Expiration Date
Abstract
Described herein are orodispersible films comprising a film forming hydrophobic polymer, a disintegrant, a plasticizer and a stabilizer.
Core Innovation
The invention relates to an orodispersible film comprising a film forming polymer, wherein the film forming polymer is polyvinyl acetate, a disintegrant, and polyvinyl alcohol (PVA) or hydroxypropylmethyl cellulose (HPMC). The polyvinyl acetate concentration in the orodispersible film is between 30% and 95% by weight. The formulation is presented as an orodispersible film designed to disintegrate when contacted orally.
The disclosed film compositions use a hydrophobic or water-insoluble film-forming polymer in combination with a disintegrant and a stabilizer system using PVA and/or HPMC. The document describes optional components including a plasticizer, film-forming polymer dispersant, and various additives such as sweeteners, saliva stimulants, buffers, taste-masking agents, flavors, colorants, and surfactants.
The document presents multiple formulation examples based on polyvinyl acetate, shellac, and methacrylate copolymers, including films that include drug substances and examples with high active loading. For these films, the document reports measured properties including disintegration time and contact-angle behavior, together with mechanical performance of multiple batches.
Claims Coverage
The independent claim family contains one independent claim with a defined three-component structure, plus dependent refinements that add specific component identities and quantitative composition and performance constraints. Across the dependent claims, the inventive features include component selection, quantitative weight-percentage ranges, disintegration-time thresholds upon contacting oral mucosa, and optional inclusion of active agents and additives.
Three-component orodispersible film with polyvinyl acetate
An orodispersible film comprising a film forming polymer, wherein the film forming polymer is polyvinyl acetate, wherein the concentration of the polyvinyl acetate in the orodispersible film is between 30% and 95% by weight; a disintegrant; and polyvinyl alcohol (PVA) or hydroxypropylmethyl cellulose (HPMC).
PVA/HPMC and sodium carboxymethylcellulose weight ranges with total component constraint
The orodispersible film further defines weight-percentage ranges for polyvinyl alcohol (PVA) or hydroxypropylmethyl cellulose (HPMC) (between 1% and 21% by weight) and sodium carboxymethylcellulose as the disintegrant (between 1% and 22% by weight), with total percentage by weight of all the components not exceeding 100%.
Rapid disintegration upon contacting oral mucosa
The orodispersible film disintegrates upon contacting oral mucosa in ≤90 seconds.
Specified dispersants composition
The one or more dispersants comprise sodium lauryl sulfate, povidone, macrogol cetostearyl ether, and sorbic acid and sodium hydroxide.
Plasticizer selected from defined citrate derivatives and polyols
The plasticizer is selected from citrate derivatives, triethylcitrate, glycerol, polyethylene glycol, or propylene glycol.
Optional active agent categories
The orodispersible film further comprises an active agent selected from a pharmaceutical agent, nutraceutical agent, supplement, or cosmetic agent.
The claim coverage centers on an orodispersible film where a polyvinyl acetate film-forming polymer at 30% to 95% by weight is combined with a disintegrant and either PVA or HPMC. Dependent claims further specify quantitative component ranges, require rapid disintegration upon oral mucosa contact (≤90 seconds), and refine formulation options using defined dispersants, defined plasticizer selections, and optional inclusion of active agents.
Stated Advantages
Rapid disintegration upon contacting oral mucosa in ≤90 seconds.
Documented Applications
The document describes orodispersible films that include drug substances.
The document describes orodispersible films that include active-agent categories including pharmaceutical agents, nutraceutical agents, supplements, or cosmetic agents.
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