Customized polypills having high drug loads

Abstract

Patient-specific polypills, or similar drug products with potential to benefit from reduced need for bulking agent and preferably having multiple active ingredients, producible via appropriately adapted “micro-dosing” technologies not requiring fluid-jet or like substrate and solvent dependent approaches, having less need for excipient, particularly filler, so that the products may contain a larger number of different drug substances having a lower overall number or amount of excipient materials and/or may contain drug substances having comparatively less need for formulation development or pre-production processing and/or may contain fewer potential causes of side effects.

What is claimed is: 
     
         1 . A customized multiple-unit-dose drug product, comprising:
 two or more solid-form drug substances combined in one directly or indirectly ingestible drug product, at respective dose levels specific to one particular patient, wherein at least one drug substance is not blended or otherwise formulated with a non-functional diluent, said non-functional diluent being an ingredient for augmenting mass or volume to accommodate ease of processing and accuracy of measurement, and wherein said at least one drug substance is not on a sheet or other substrate; and   a barrier limiting contact between at least two of said two or more drug substances.   
     
     
         2 . The product of  claim 1 , wherein said drug substances are contained within respective compartments of a multi-compartment capsule, thereby achieving said barrier. 
     
     
         3 . The product of  claim 1 , wherein a drug substance(s) is contained within a first capsule shell that is contained within a second capsule shell containing another substance(s), thereby achieving said barrier. 
     
     
         4 . The product of  claim 1 , wherein a drug substance(s) is formulated with an excipient whose presence reduces contact between drug substances, thereby achieving said barrier. 
     
     
         5 . The product of  claim 1 , wherein said at least one drug substance is present as encapsulated granule or bead particles comprising functional excipient(s), the encapsulation achieving said barrier. 
     
     
         6 . The product of  claim 1 , wherein said at least two of said two or more drug substances are present as solidified beads, such that contact between said at least two of said two or more drug substances is limited to essentially said beads' surfaces, thereby achieving said barrier. 
     
     
         7 . The product of  claim 6 , wherein said beads are of a kind producible by any known fluid bed pelletization or spray-drying technolog(ies). 
     
     
         8 . The product of  claim 7 , wherein said beads are at least about 75 percent active ingredient. 
     
     
         9 . The product of  claim 8 , wherein said beads comprise matrix-type pellets. 
     
     
         10 . The product of  claim 9 , wherein said pellets are microspheres having a functional coating, and wherein said drug substances are encapsulated in a capsule shell or other envelopment that is directly ingestible. 
     
     
         11 . A customized multiple-unit-dose drug product, comprising:
 two or more drug substances whose respective identities and dose levels are customized for a particular patient and combined in a single ingestible or otherwise orally-administrable drug product, wherein at least one of said drug substances is not in formulation with a non-therapeutic excipient, said non-therapeutic excipient being an ingredient that is not intended to directly or indirectly facilitate pharmacokinetics or pharmacodynamics in vivo, and wherein said at least one of said drug substances is not on a sheet or other substrate; and   a barrier for limiting in vitro contact between at least two of said two or more drug substances.   
     
     
         12 . The product of  claim 11 , wherein at least one drug substance is combined with an excipient that was selected for said particular patient. 
     
     
         13 . The product of  claim 11 , wherein at least one drug substance is a solid, and wherein the drug product is designed to be directly swallowable without chewing or mixing or sprinkling or dissolving, and wherein the drug product is packaged in compliance packaging. 
     
     
         14 . The product of  claim 11 , wherein at least one drug substance is a pure raw active pharmaceutical ingredient. 
     
     
         15 . The product of  claim 11 , wherein no drug substance is formulated with a glidant or flow enhancer. 
     
     
         16 . A customized multiple-unit-dose drug product, comprising:
 two or more drug substances at dose levels essentially as prescribed for a particular patient, combined in one drug product having an enteral or otherwise non-intravenous route of administration, wherein at least one drug substance is present without significant functional or non-functional excipient, said at least one drug substance not having been deposited as a liquid onto an intermediary substrate; and   a barrier for restricting contact between at least two drug substances.   
     
     
         17 . The product of  claim 16 , wherein said at least one drug substance is in particles having sufficient uniformity such that each particle contributes an approximately equal amount of active ingredient to the drug product. 
     
     
         18 . The product of  claim 16 , wherein an inactive pharmaceutical ingredient or a nutriceutical ingredient is present in the drug product but not in formulation with any active pharmaceutical ingredient. 
     
     
         19 . The product of  claim 16 , wherein a drug substance(s) exists in formulation with an excipient that is medically appropriate for at least a portion of patients who use said drug substance(s), and wherein the drug product is prepared for an oral route of administration. 
     
     
         20 . The product of  claim 16 , wherein a drug substance(s) is formulated with at least one functional excipient serving either a bioavailability-enhancing purpose in vivo or a stability-enhancing purpose in vitro.