Oral Transmucosal Drug Delivery System

An oral transmucosal dosage form comprising

• (a) a primary vehicle comprising
• (i) a crystallization inhibition agent (CIA), and
• (ii) a drug, wherein the drug is selected from the group consisting of a practically insoluble drug, very slightly soluble drug, slightly soluble drug, or sparingly soluble drug;
• and
• (b) a secondary vehicle comprising
• (i) a hydrophilic water soluble component, and
• (ii) a texturizing agent,
• wherein said oral transmucosal dosage form comprises the drug having at least a 50% reduction in crystallinity as measured by a DSC thermogram relative to a dosage form not comprising a CIA.

An oral transmucosal dosage form comprising

• (a) a primary vehicle comprising
• (i) a crystallization inhibition agent (CIA), and
• (ii) a drug, wherein the drug is selected from the group consisting of a practically insoluble drug, very slightly soluble drug, slightly soluble drug, or sparingly soluble drug;
• and
• (b) a secondary vehicle comprising
• (i) a hydrophilic water soluble component, and
• (ii) a texturizing agent,
• wherein the drug in said oral transmucosal dosage form has increased permeability across a polysulfone membrane relative to a drug in a dosage form not comprising the CIA.

An oral transmucosal dosage form comprising

• (a) a primary vehicle comprising
• (i) a crystallization inhibition agent (CIA), and
• (ii) a drug, wherein the drug is selected from the group consisting of a practically insoluble drug, very slightly soluble drug, slightly soluble drug, or sparingly soluble drug;
• and
• (b) a secondary vehicle comprising
• (i) a hydrophilic water soluble component, and
• (ii) a texturizing agent,
• wherein the drug in said oral transmucosal dosage form has increased permeability across a transmucosal membrane relative to a drug in a dosage form not comprising the CIA.

An oral transmucosal dosage form comprising

• (a) a primary vehicle comprising
• (i) a hydrophilic crystallization inhibition agent,
• (ii) a lipophilic crystallization inhibition agent,
• (iii) an amphiphilic crystallization inhibition agent, and
• (iv) testosterone;
• and
• (b) a secondary vehicle comprising
• (i) a hydrophilic water soluble component, and
• (ii) a texturizing agent,
• wherein said oral transmucosal dosage form weighs about 250 mg to about 5000 mg, said oral transmucosal dosage form erodes in about 5 to about 60 minutes, but does not disintegrate, and said oral transmucosal dosage form is solid at 37° C.

A method of making an oral transmucosal dosage form comprising the steps of

• i) providing a crystallization inhibition agent selected from the group consisting of a hydrophilic crystallization inhibition agent, an amphiphilic crystallization inhibition agent, or a lipophilic crystallization inhibition agent;
• ii) apply heat to melt said crystallization inhibition agent, and mixing to create a molten mixture;
• iii) adding a drug to said molten mixture, and mixing said drug and said molten mixture;
• iv) cooling said molten mixture and milling said molten mixture to form a powder primary vehicle;
• v) adding a secondary vehicle to said powder primary vehicle and mixing;
• and
• vi) compressing said secondary vehicle and powder primary vehicle into an oral transmucosal dosage form,
• wherein said transmucosal dosage form is about 250 mg to about 5000 mg, erodes in about 5 to about 60 minutes, but does not disintegrate, and is solid at 37° C.

A method of making an oral transmucosal dosage form comprising the steps of

• i) melting a single or a mixture of one or more crystallization inhibition agents selected from the group consisting of hydrophilic crystallization inhibition agents, lipophilic crystallization inhibition agents, amphiphilic crystallization inhibition agents, or combinations thereof;
• ii) adding appropriate stabilizing agent(s) if necessary;
• iii) adding drug or active pharmaceutical ingredient to molten crystallization inhibition agent(s), and mixing;
• iv) mixing appropriate components of the secondary vehicle with the molten mixture in either elevated or room temperature;
• v) cooling the resultant mixture if necessary;
• vi) milling the resultant mixture through a mill to form a powder, which serves as the primary vehicle;
• vii) mixing the remaining portion of the secondary vehicle with the primary vehicle;
• viii) compressing said secondary vehicle and powder primary vehicle into an oral transmucosal dosage form;
• wherein said transmucosal dosage form is about 250 mg to about 5000 mg, erodes in about 5 to 60 minutes, but does not disintegrate and is solid at 37° C.

A method of making an oral transmucosal dosage form comprising the steps of:

• i) mixing drug or active pharmaceutical ingredient with one or more hydrophilic crystallization inhibition agent(s);
• ii) solubilizing this mixture in an appropriate solvent or a mixture of solvents;
• iii) mixing the solution with the hydrophilic water soluble component(s) of the secondary vehicle;
• iv) evaporating the solvent(s) using oven, obtaining a dispersion of the drug in hydrophilic crystallization inhibition agent(s) mixed uniformly with hydrophilic water soluble portion of the secondary vehicle, which will act as the primary vehicle;
• v) milling the primary vehicle using a mill to form a powder;
• vi) mixing the powder from the previous step with the remaining portion of the secondary vehicle;
• and
• vii) compressing said secondary vehicle and powder primary vehicle into an oral transmucosal dosage form;
• wherein said transmucosal dosage form is about 250 mg to about 5000 mg, erodes in about 5 to 60 minutes, but does not disintegrate and is solid at 37° C.

An oral transmucosal dosage form comprising:

• (a) a primary vehicle comprising
• (i) a crystallization inhibition agent, and
• (ii) a drug, wherein the drug is selected from the group consisting of a practically insoluble drug, very slightly soluble drug, slightly soluble drug, or sparingly soluble drug;
• and
• (b) a secondary vehicle comprising
• (i) a hydrophilic water soluble component, and
• (ii) a texturizing agent,
• wherein said oral transmucosal dosage form weighs about 250 mg to about 5000 mg and is solid at 37° C., and wherein said crystallization inhibition agent facilitates decrystallization of said drug, and during dissolution of said oral transmucosal dosage form said crystallization inhibition agent prevents recrystallization of said drug.