Fast dissolving solid dosage form
AssigneeiX Biopharma Ltd.
InventorsChin Beng Stephen Lim, Vivian Bruce Sunderland, Yip Hang Eddy Lee
Life of this patent
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Abstract
There is provided a fast dissolving solid dosage form adapted for the release of a biologically active material in the oral cavity wherein the dosage form comprises at least one biologically active material, and at least one matrix forming agent, wherein the dosage form substantially dissolves in the oral cavity. A method of producing the same and a kit comprising the same are also provided.
Claims29
A fast disintegrating and dissolving freeze-dried wafer solid dosage form with a porous matrix for release of a biologically active material in an oral cavity wherein said dosage form comprises:
- (a) a biologically active material;
- (b) amylopectin at a concentration from 2% to 17% by dry weight of the dosage form;
- (c) sodium carboxymethyl cellulose (CMC) at a concentration from 0.1 to 15% dry weight of the dosage form;
- and
- (d) a carbohydrate chosen from a list consisting of:
- mannitol, dextrose, lactose, galactose and trehalose at a concentration from 5% to 80% by dry weight of the dosage form,
- wherein the powder x-ray diffraction (XRD) of the dosage form comprises peaks at 2-theta values at approximately 9.58 degrees, 19.68 degrees, and 20.05 degrees;
- and
- wherein said dosage form disintegrates in the oral cavity in a time of less than 15 seconds and dissolves in the oral cavity in a time of less than 60 seconds without leaving a residue of said dosage form in the oral cavity that is detectable by a subject, thereby avoiding the urge for the subject to swallow the dosage form;
- wherein said biologically active material is absorbed by diffusion directly into the systemic circulation;
- wherein the amylopectin is not in the form of starch or modified starch.
A kit comprising a fast disintegrating and dissolving freeze-dried wafer solid dosage form with a porous matrix for release of a biologically active material in an oral cavity, wherein the dosage form comprises:
- (a) a biologically active material;
- (b) amylopectin at a concentration from 2% to 17% by dry weight of the dosage form;
- (c) sodium carboxymethyl cellulose (CMC) at a concentration from 0.1 to 15% dry weight of the dosage form;
- and
- (d) a carbohydrate chosen from a list consisting of:
- mannitol, dextrose, lactose, galactose and trehalose at a concentration from 5% to 80% by dry weight of the dosage form,
- wherein the powder x-ray diffraction (XRD) of the dosage form comprises peaks at 2-theta values at approximately 9.58 degrees, 19.68 degrees, and 20.05 degrees;
- wherein the dosage form dissolves in the oral cavity without leaving a residue of said dosage form in the oral cavity that is detectable by a subject, thereby avoiding the urge for the subject to swallow the dosage form;
- wherein said dosage form disintegrates in the oral cavity in a time of less than 15 seconds and dissolves in the oral cavity in a time of less than 60 seconds;
- wherein said dosage form is absorbed by diffusion directly into the systemic circulation;
- wherein the amylopectin is not in the form of starch or modified starch;
- and
- wherein the solid dosage form is not a film.
A freeze-dried wafer dosage form with a porous matrix for release of a biologically active material in an oral cavity wherein said dosage form comprises:
- (a) a biologically active material;
- (b) a matrix forming agent comprising amylopectin at a concentration from 2% to 17% by dry weight of the dosage form;
- (c) sodium carboxymethyl cellulose (CMC) at a concentration from 0.1 to 15% dry weight of the dosage form;
- and
- (d) a carbohydrate chosen from a list consisting of:
- mannitol, dextrose, lactose, galactose and trehalose at a concentration from 5% to 80% by dry weight of the dosage form,
- wherein the powder x-ray diffraction (XRD) of the dosage form comprises peaks at 2-theta values at approximately 9.58 degrees, 19.68 degrees, and 20.05 degrees;
- wherein said dosage form disintegrates in the oral cavity in a time of less than 15 seconds and dissolves in the oral cavity in a time of less than 60 seconds without leaving a residue of said dosage form in the oral cavity that is detectable by a subject;
- wherein said biologically active material is absorbed by diffusion directly into the systemic circulation;
- wherein the amylopectin is not in the form of starch or modified starch;
- and
- wherein the solid dosage form is not a film.
Dependencies are inferred from the claim text.