Pharmaceutical oral dose formulation and composition of matter
OwnerDavid W. Throwerinventor
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Abstract
An apparatus and method for formulating low solubility, low permeability and/or p-glycoprotein efflux transporter substrate drugs or herbal extracts for increased intestinal absorption. The method utilizes a supercritical fluid, such as carbon dioxide to complex a low solubility, low permeability and/or p-glycoprotein efflux transporter substrate drug or herbal extract, the p-glycoprotein inhibitors quercitin and piperine, with a carbohydrate. The result is a micro-emulsion of the drug or herbal extract which has both higher solubility and permeability than if dosed alone; as well as resistance to p-glycoprotein mediated efflux, once absorbed into the intestinal lumen.
Claims4
A process for providing an oral pharmaceutical formulation for a low solubility, low permeability and/or p-glycoprotein efflux transporter substrate active pharmaceutical ingredient or herbal extract by complexing said a low solubility, low permeability and/or p-glycoprotein efflux transporter substrate active pharmaceutical ingredient or herbal extract with a carbohydrate using a supercritical fluid, the process comprising the steps of:
- a. placing the active pharmaceutical ingredient or herbal extract in an extraction processing tank on top of a filter apparatus;
- b. compressing said extraction processing tank to a pressure of no more than 1500 PSI a temperature of no more than 150° C. and a supercritical or liquid carbon dioxide solution;
- c. agitating said active pharmaceutical ingredient or herbal extract;
- d. compressing said carbon dioxide solution through said active pharmaceutical ingredient or herbal extract, followed by compression through a filtration apparatus at a flow rate of no more than 100 linear inches/min;
- e. loading an API:solvent to API:excipient processing tank processing tank with a carbohydrate excipient;
- f. equilibrating said API:solvent to API:excipient processing tank processing tank to a pressure of no more than 1500 PSI a temperature of no more than 42° C. and a supercritical carbon dioxide solution;
- g. pumping the active pharmaceutical ingredient or herbal extract and solvent into said excipient transfer processing tank;
- h. reducing the pressure in said excipient processing tank;
- wherein said API and carbohydrate fall out of solution and form an API:carbohydrate complex;
- i. removing spent carbon dioxide solvent, compressing said spent carbon dioxide solvent through a filter, re-compressing said spent carbon dioxide into a holding tank;
- j. removing said API:carbohydrate complex from said extraction processing tank;
- k. placing the quercitin extract in an extraction processing tank on top of a filter apparatus;
- l. compressing said extraction processing tank to a pressure of no more than 1500 PSI a temperature of no more than 42° C. and a supercritical or liquid carbon dioxide solution;
- m. agitating said active pharmaceutical ingredient or herbal extract;
- n. compressing said carbon dioxide solution through said active pharmaceutical ingredient or herbal extract, followed by compression through a filtration apparatus at a flow rate of no more than 100 linear inches/min;
- o. loading an quercitin:solvent to quercitin:excipient processing tank processing tank with a carbohydrate excipient;
- p. equilibrating said quercitin:solvent to quercitin:excipient processing tank processing tank to a pressure of no more than 1500 PSI a temperature of no more than 42° C. and a supercritical carbon dioxide solution;
- q. pumping the active pharmaceutical ingredient or herbal extract and solvent into said excipient transfer processing tank;
- r. reducing the pressure in said excipient processing tank;
- wherein said quercitin and carbohydrate fall out of solution and form an quercitin:carbohydrate complex;
- s. removing spent carbon dioxide solvent, compressing said spent carbon dioxide solvent through a filter, re-compressing said spent carbon dioxide into a holding tank;
- t. removing said quercitin:carbohydrate complex from said extraction processing tank;
- u. placing the piperine extract in an extraction processing tank on top of a filter apparatus;
- v. compressing said extraction processing tank to a pressure of no more than 1500 PSI a temperature of no more than 42° C. and a supercritical or liquid carbon dioxide solution;
- w. agitating said active pharmaceutical ingredient or herbal extract;
- x. compressing said carbon dioxide solution through said active pharmaceutical ingredient or herbal extract, followed by compression through a filtration apparatus at a flow rate of no more than 100 linear inches/min;
- y. loading an piperine:solvent to piperine:excipient processing tank processing tank with a carbohydrate excipient;
- z. equilibrating said piperine:solvent to piperine:excipient processing tank processing tank to a pressure of no more than 1500 PSI a temperature of no more than 42° C. and a supercritical carbon dioxide solution;
- aa. pumping the active pharmaceutical ingredient or herbal extract and solvent into said excipient transfer processing tank;
- bb. reducing the pressure in said excipient processing tank;
- wherein said piperine and carbohydrate fall out of solution and form an piperine:carbohydrate complex;
- cc. removing spent carbon dioxide solvent, compressing said spent carbon dioxide solvent through a filter, re-compressing said spent carbon dioxide into a holding tank;
- dd. removing said piperine:carbohydrate complex from said extraction processing tank;
- ee. blending said API:carbohydrate, said piperine:carbohydrate and said quercitin carbohydrate to the desired concentration.
Dependencies are inferred from the claim text.