Abstract: An oral dosage form that provides for the controlled release of an analgesic wherein the dosage form comprises a core containing an analgesic that is coated with a mixture of an enteric polymer, a water insoluble polymer and a lubricant.

Abstract: An analgesic controlled release dosage form containing: (a) 40-80 weight percent of an analgesic; (b) 10-30 weight percent of a pharmaceutically acceptable filler; and (c) 10-30 weight percent of a carrier base wherein the carrier base is formed from a high molecular weight hydroxypropyl methylcellulose, a water soluble binder and optionally a water insoluble binder.

Abstract: A pharmaceutical composition of omeprazole for oral administration is described which consists essentially of: (a) a tabletted core component containing a therapeutically effective amount of omeprazole, a surface active agent, a filler, a pharmaceutically acceptable alkaline agent and a binder; and (b) a single layer of coating on said core which comprises a layer of an enteric coating agent.

Abstract: The invention provides a delayed-pulse controlled release pharmaceutical tablet having:(a) from 20 to 60 wt. % of a low molecular weight hydroxypropyl cellulose having a number average molecular weight of 70,000 to 90,000;(b) from 4 to 10 wt. % of a high molecular weight hydroxypropyl cellulose having a number average molecular weight of 1,100,000 to 1,200,000;(c) a pharmacologically acceptable amount of a medicament; and(d) an inert solid diluent.

Abstract: A controlled release antihyperglycemic tablet that does not contain an expanding polymer and comprising a core containing the antihyperglycemic drug, a semipermeable membrane coating the core and at least one passageway in the membrane.

Abstract: A pharmaceutical composition of omeprazole for oral administration is described which consists essentially of:(a) a pellet comprising an inert core component, a therapeutically effective amount of omeprazole, a surface active agent, a filler, a pharmaceutically acceptable alkaline agent and a binder; and(b) a single layer of coating on said pellet which comprises a layer of an enteric coating agent.

Abstract: A pharmaceutical composition of omeprazole for oral administration is described which consists essentially of:(a) a pellet comprising an inert core component, a therapeutically effective amount of omeprazole, a surface active agent, a filler, a pharmaceutically acceptable alkaline agent and a binder; and(b) a single layer of coating on said pellet which comprises a layer of an enteric coating agent.

Abstract: A controlled release dosage form which comprises:(a) a homogeneous compressed core which comprises a compressed granulation of:(i) particles of a calcium channel blocker compound coated with an enteric polymer that are dispersed onto a solid pharmaceutical filler; and(b) a continuous compressed outer layer around said homogeneous compressed core which comprises a compressed granulation of:(i) one or more pharmaceutically acceptable polymers which form a hydrogel in which calcium channel blocker compound is dispersed.

Abstract: A controlled release nifedipine tablet which comprises:(a) a homogeneous compressed core which comprises:(i) a medicament;(ii) a water soluble osmotic compound(iii) one or more osmotic polymers; and(b) a membrane coating which completely covers said core tablet which comprises a mixture of:(i) a water insoluble pharmaceutically acceptable polymer; and(ii) an enteric polymer.

Abstract: A once-a-day controlled release diltiazem formulation is described which includes:(a) from 20 to 50% by weight of enteric polymeric membrane coated pellets comprising a polymer membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of diltiazem and a polymeric binder; and a second layer which comprises a membrane comprising a pH dependent polymeric material; and(b) from 50% to 80% by weight of delayed pulse polymeric membrane coated pellets comprising a polymeric membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of diltiazem and a polymeric binder and a second layer which comprises a polymeric membrane which will substantially maintain its integrity in the varying pH conditions of the gastrointestinal tract but is permeable to diltiazem; and(c) a unit dose containment system.

Abstract: A once-a-day diltiazem dosage form which comprises: (a) a core element which is a compressed tablet which contains a therapeutic dose of diltiazem and an amount of a solubility modulating substance that controls the release of said diltiazem in order to provide a therapeutic level over a period of about 24 hours; and (b) on the outer surface of the core element, a sufficient amount of an enteric coating that causes the diltiazem to release at a rate that permits the use of once-a-day dosing to maintain steady state therapeutic levels of diltiazem.

Abstract: A controlled release pharmaceutical tablet is disclosed which is based on:(a) a compressed core which contains:(i) a medicament;(ii) at least 23% to 55% by weight, based on the total weight of the core, of a water soluble osmotic agent;(iii) a water soluble pharmaceutically acceptable polymeric binder;(iv) a water-swellable pharmaceutically acceptable polymer;(v) a conventional pharmaceutical excipient; and(b) a membrane coating around said core tablet which consists essentially of:(i) a modified water insoluble pharmaceutically acceptable polymer; and(ii) a pharmaceutically acceptable water soluble polymer.

Abstract: The invention provides a controlled release pharmaceutical unit dose composition for oral administration which comprises: (a) an internal phase which comprises captopril or a prodrug of captopril in admixture with a hydrogel forming agent; and (b) an external phase which comprises a coating which resists dissolution in the stomach.

Abstract: A controlled release pharmaceutical tablet having at least one passageway, said tablet having:(a) a compressed core which comprises:(i) a medicament;(ii) an amount of a water soluble osmotic agent which is effective to cause the medicament to be delivered from said passageway in the presence of aqueous media;(iii) a water-swellable pharmaceutically acceptable polymer; and(b) a membrane coating around said core tablet which comprises a water insoluble pharmaceutically acceptable polymer.

Abstract: A once-a-day controlled release diltiazem formulation is described which includes:(a) from 20 to 50% by weight of enteric polymeric membrane coated pellets comprising a polymer membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of diltiazem and a polymeric binder; and a second layer which comprises a membrane comprising a pH dependent polymeric material; and(b) from 50% to 80% by weight of delayed pulse polymeric membrane coated pellets comprising a polymeric membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of diltiazem and a polymeric binder and a second layer which comprises a polymeric membrane which will substantially maintain its integrity in the varying pH conditions of the gastrointestinal tract but is permeable to diltiazem; and(c) a unit dose containment system.

Abstract: A controlled release pharmaceutical tablet is disclosed which is based on:(a) a compressed core which contains:(i) a medicament;(ii) from 5 to 20% by weight of a water soluble osmotic agent based on the total weight of the compressed core;(iii) a water soluble pharmaceutically acceptable polymeric binder;(iv) a conventional pharmaceutical excipient; and(b) a dual layer membrane coating around said core which consists essentially of:(i) a first inner coating layer for sustained release of the medicament, said inner coating layer consisting essentially of a plasticized water insoluble pharmaceutically acceptable polymer and a pharmaceutically acceptable water soluble polymer, and;(ii) a second outer coating layer for immediate release of a medicament, said outer coating layer consisting essentially of an effective amount of a medicament and a water soluble polymer.The controlled release formulation is suitable for the once-a-day administration of medicaments.

Abstract: A novel method of treating wounds has been discovered that is based on the system and/or topically administration of an effective amount, of para-amino benzoic acid or its derivatives, to a patient who has a wound, the healing of the wound will be promoted and scar formation will be reduced. In addition, it has been discovered that by systemically and/or topically administering an effective amount of para-amino benzoic acid or its derivatives, to a patient who has scar tissue or keloids, the scar tissue and/or keloid tissue will regress and/or soften to allow the skin in the area of the scar or keloid to become more flexible.

Abstract: A unit dosage form of capsule, tablet or the like is composed of a large number of pellets made up of two or more populations of pellets or particles. Each pellet contains a core containing the therapeutic drug and a water soluble osmotic agent. A water-permeable, water-insoluble polymer film encloses each core. Incorporated into the polymer film is a hydrophobic, water insoluble agent which alters the permeability of the polymer film. The film coating of each population of pellets differs from the coating of every other population of pellets in the dosage form in the rate at which water passes through to the core and the rate at which drug diffuses out of the core. The osmotic agent dissolves in the water, causing the pellet to swell and regulating the rate of diffusion of drug into the environment of use. As each population of pellets releases its drug into the environment sequentially, the effect is to provide a series of pulsatile administrations of the drug from a single dosage form.

Abstract: Unit dosage form for delivering drugs into the body in a series of sequential, pulsatile releasing events employs conventional pharmaceutical equipment and processes for optimum economy, reliability, and bioavailability. The system can be used with drugs which cannot be released by diffusion through a porous coating, such as water insoluble drugs. A plurality of populations of pellets is provided within a unit dosage form such as a capsule (8) or tablet. The pellets are composed of a core containing the drug (3) and a swelling agent (4) which expands in volume when exposed to water. The core is enclosed within a membrane or coating which is permeable to water. The membrane is composed of a water insoluble and permeable film forming polymer, a water soluble film forming polymer (11) and a permeability reducing agent (14). When the unit dose releases the pellets into the digestive tract, water diffuses through the coating and into the core.

Abstract: The present invention is directed to a controlled release dosage form which may be made using an osmotic core which contains a drug containing phase which includes a water swellable component and a continuous coating which comprises a major amount of a water resistant polymer and a minor amount of a non-toxic, water soluble, pharmaceutically acceptable compound.