SOLID ORAL FILM DOSAGE FORMS AND METHODS FOR MAKING SAME
First Claim
1. A oral film dosage form that maintains a plurality of active ingredient particles in an effective particle size range to maintain reduced structural order, and/or improve solubility and bioavailability of the active, comprising:
- at least one pharmaceutically active ingredient in the form of particles and capable of existing in amorphous and crystalline forms;
at least one primary crystallization inhibitor present in an amount that inhibits growth and/or agglomeration of the particles of the pharmaceutically active ingredient;
at least one liquid crystallization inhibitor present in an amount that enhances inhibition of crystallization and/or agglomeration of the particles of the pharmaceutically active ingredient; and
at least one plasticizer present in an amount that is effective to increase flexibility and elasticity of the film dosage form.
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Accused Products
Abstract
Improved pharmaceutical solid oral film dosage forms for the buccal and/or sublingual delivery of pharmaceutical, nutraceutical or cosmetic ingredients are endowed with instant hydration potential and complete dissolution potentially enabling the active ingredient to become immediately available for enhanced buccal and/or sublingual absorption and/or reduced absorption through the gastrointestinal route. The improved delivery systems for solubilizing and stabilizing pharmaceutically active ingredients exhibit enhanced stability by the use of a combination of crystallization inhibitors, which together can maintain the active ingredient in a desired plurality of particles in an effective size range within a polymeric film matrix.
108 Citations
37 Claims
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1. A oral film dosage form that maintains a plurality of active ingredient particles in an effective particle size range to maintain reduced structural order, and/or improve solubility and bioavailability of the active, comprising:
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at least one pharmaceutically active ingredient in the form of particles and capable of existing in amorphous and crystalline forms; at least one primary crystallization inhibitor present in an amount that inhibits growth and/or agglomeration of the particles of the pharmaceutically active ingredient; at least one liquid crystallization inhibitor present in an amount that enhances inhibition of crystallization and/or agglomeration of the particles of the pharmaceutically active ingredient; and at least one plasticizer present in an amount that is effective to increase flexibility and elasticity of the film dosage form. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 35, 36, 37)
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15. A method of administering a therapeutically effective amount of at least one active ingredient present as an effectively stabilized plurality of particles in an oral film dosage form, comprising:
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disposing a pharmaceutically active ingredient in the form of particles that is capable of existing in both amorphous and crystalline forms into a suitable liquid medium containing at least one primary crystallization inhibitor present in an amount that inhibits growth and/or agglomeration of the particles of the pharmaceutically active ingredient, at least liquid crystallization inhibitor present in an amount that enhances inhibition of crystallization and/or agglomeration of the particles of the pharmaceutically active ingredient, and at least one plasticizer present in an amount that is effective to increase flexibility and elasticity of the film dosage form; casting and drying the composition to make a solid oral dosage form; applying the dosage form in a subject'"'"'s mouth and having the subject maintain the dosage form in the subject'"'"'s mouth until an effective quantity of the dosage form has dissolved, whereby a therapeutic effect is achieved. - View Dependent Claims (16, 17, 18, 19, 20)
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21. An oral film dosage form demonstrating a solubilization profile of at least one active ingredient resulting from the combination of two or more distinct, effectively stabilized, particle size ranges, comprising:
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at least one primary crystallization inhibitor present in an amount that inhibits growth and/or agglomeration of the particles of the pharmaceutically active ingredient; at least one liquid crystallization inhibitor present in an amount that enhances inhibition of crystallization and/or agglomeration of the particles of the pharmaceutically active ingredient; and at least one plasticizer present in an amount that is effective to increase flexibility and elasticity of the film dosage form. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34)
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Specification