Abstract: A drug delivery system (10) includes a first capsule half (12) having an inner chamber (16) containing a drug (18) therein. A plug (28) is disposed in a passageway (26) of the capsule half (12) for plugging the opening (24) thereof. The plug (28) is releasable from the passageway opening (24) upon the application of pressure from within the inner chamber (16). A pump mechanism, reactive with the external environment of the capsule half (12), causes an increase in pressure within the inner chamber (16) and forces the plug (28) out of the passageway (26) to release the drug (18) from the inner chamber (16) and out of the passageway (26). Thusly, after initial release of drug from a second capsule half (14) releasably mounted on the first capsule half (12), the first capsule half (12) provides a second pulse of drug release at a predetermined time after initial ingestion of the capsule.

Abstract: A dosage form is disclosed comprising a wall that defines an injection-molded compartment housing a capsule comprising a drug formulation.

Abstract: Means for delivering a beneficial substance such as vitamin E to an animal, employing a pump means in the form of a device (10, 110 or 210) containing a material such as a silicate gel which swells by absorption of waer, for example from the digester in the case of a bolus, to apply pressure to an elastic container for the beneficial substance, whereby to cause the beneficial substance to be expelled through an exit orifice.

Abstract: A simulated capsule-like medicament comprising a subcoating of a mixture of a water-soluble, film-forming polymer, e.g. hydroxypropylmethyl cellulose and a hydrophobic plasticizer, e.g. castor oil, which promotes a smooth uniform and substantially bubble free outer coating, e.g. gelatin, for the capsule-like medicament; capsule-like medicaments which are slightly bowed in shape; and a process of making such medicaments.

Abstract: Provided are therapeutic compositions which provide high bioavailability of the active ingredients from the group of cyclosporin, at the same time permitting concentrations in dosage forms higher than 10%.

Abstract: A process for encapsulation of caplets in a capsule comprises the following steps: a. providing empty capsule parts; b. filling at least one of said capsule parts with one or more caplets; c. putting said capsule parts together; and d. treating the combined parts by cold shrinking. The solid dosage forms obtainable by such aprocess are tamper-proof in that they cannot be opened in a way to be reassembled without showing such opening process.

Abstract: A drug delivery system (10) includes a first capsule half (12) having an inner chamber (16) for containing a drug (18) therein. A plug (28) is disposed in a passageway (26) of the capsule half (12) for plugging the opening (24) thereof. The plug (28) is releasable from the passageway opening (24) upon the application of pressure from within the inner chamber (16). A pump mechanism, reactive with the external environment of the capsule half (12), causes an increase in pressure within the inner chamber (16) and forces the plug (28) out of the passageway (26) to release the drug (18) from the inner chamber (16) and out of the passageway (26). Thusly, after initial release of drug from a second capsule half (14) releasably mounted on the first capsule half (12), the first capsule half (12) provides a second pulse of drug release at a predetermined time after initial ingestion of the capsule.

Abstract: A dispenser for use in a fluid environment of use which is capable of the delivery of one or a plurality of discrete active agent-containing units in any desired delivery pattern or profile. It also can provide for the initially delayed delivery of an active agent to the environment of use and for high accuracy in the timing of delivery of the active agent.

Abstract: The present invention is directed to a fluid-imbibing drug delivery device which is useful for the initial delayed delivery of an active agent formulation to a fluid environment of use, the initial delay period to startup or activation of the device being of a predetermined length of time. The delivery of the agent formulation from the dispensing device is continued until essentially all of the active agent formulation is delivered as a result of the fluid inhibition into a fluid flow path in the housing of the device and the expansion of an expansion agent in the active agent delivery chamber.

Abstract: A delivery device for delivering an active substance to a patient at a predetermined time after administration comprises a male hydrogel plug engaged in the neck of a female body. An expandable excipient such as a hydrogel powder or a pharmaceutical disintegrant in powder, slug or tablet form is provided beneath the active substance. In contact with an aqueous medium, the excipient absorbs water and swells such as to rapidly expel the active substance and effectively deliver it from the device.

Abstract: A medicament includes a caplet having a peripheral land which is inserted into mating capsule shell halves each with internally formed recesses defining external peripheral lands which align when the shell halves are fitted over the caplet. In one embodiment of the invention, the internal diameter of the capsule shells is selected such that the caplet will fit within the capsule cell regardless of its orientation, while in another embodiment the caplet land mates with the internal recesses of the capsule shells. In a preferred embodiment of the invention, the capsule shells have different lengths and diameters such that one overlaps the other and can be sealed.

Abstract: The present invention is directed to a fluid-imbibing drug delivery device which is useful for the initial delayed delivery of an active agent formulation to a fluid environment of use, the initial delay period to startup or activation being of a predetermined length of time. The dispensing device is formed of a first and second housing that are in reversibly sliding telescoping arrangement with each other. The first housing contains the active agent formulation and has an aspect ratio less than 1. The housings are preferably. ovoloid in shape.

Abstract: The present invention relates to novel compositions of and methods of manufacture of controlled release formulations obtained by mixing molten drugs with molten additives to produce homogeneous drug-additive composites.

Abstract: The present invention is directed to a fluid-imbibing drug delivery device which is useful for the initial delayed delivery of an active agent formulation to a fluid environment of use, the initial delay period to startup or activation of the device being of a predetermined length of time. The delivery of the agent formulation from the dispensing device is continued until essentially all of the active agent formulation is delivered as a result of the expansion of an expansion agent in the active agent delivery chamber.

Abstract: Encapsulated small articles such as medicines in caplet or cylindrical form are disclosed. Gelatin half capsules are formed on the pins of pin blocks and are delivered to a station at which they are trimmed and fitted over the opposite ends of the product to be encapsulated. The capsule halves are first dried to a condition in which they have about 20 wt. % moisture and are thereafter press fitted over the ends of the caplets and allowed to dry to shrink fit tightly onto the caplets making it virtually impossible to remove them from their gelatin coverings without leaving visible evidence of tampering. The finished product has a smoother outer surface which lends itself to overprinting with a precise color separation line between the two capsule halves if the capsule halves are distinctly differently colored.

Abstract: A controlled release capsule comprises a male plug (2) formed of a water swellable hydrogel which is engaged within a neck portion (4) of a female body (6). The capsule contains a pharmaceutically active material. In contact with an aqueous medium, such as in the gastrointestinal tract, the hydrogel plug swells and becomes disengaged from the body, thereby releasing the active material. In order to facilitate insertion of the male plug into the neck of the body, the body has a flared mouth portion (14) which is wider than the neck. The neck itself may be wider or narrower than the remainder of the body. A water-soluble cap (8) has detentes (18) which clip over the flared mouth portion so as to lock the cap thereto.

Abstract: A controlled release capsule comprises a male plug (2) formed of a water-swellable hydrogel which is engaged with a neck portion (4) of a female body (6). The capsule is intended to deliver two dosages of pharmaceutically active material at different times. A water soluble cap (8) is fitted over mouth (14) of the body, and defines a first volume (9) containing a first unit dosage (10). A second unit dosage (12) is contained within a second volume (11) defined by the plug and the female body. When the capsule is swallowed by a patient, the cap dissolves quickly in the aqueous medium within the gastro-intestinal tract and releases the first dosage. The aqueous medium then comes into contact with the hydrogel plug which swells and becomes disengaged from the body, usually in the intestine, thereby releasing the second dosage a predetermined time after the first dosage.

Abstract: This application discloses a method of inhibiting degradation of the antidepressant bupropion hydrochloride in a solid pharmaceutical formulation, so that the pharmaceutical formulation will maintain at least 80% of its initial bupropion potency after one year.

Abstract: Sucralfate preparation produced by melt granulating a mixture of a comminuted sucralfate powder and a water-soluble low-melting point wax, as well as a process for producing a sucralfate preparation comprising the steps of comminuting dry sucralfate into fine particles, mixing the finely divided particles with a water-soluble low-melting point wax and heating the mixture such that the wax is melted to effect melt (adhesion) granulation of the finely divided sucralfate particles are disclosed. Compared to conventional sucralfate preparations, the thus produced sucralfate preparation has a small dispersed particle size, exhibits high capability for binding to plasma proteins and thereby achieves marked improvements in administrability and protein binding capability.

Abstract: A dosage form is disclosed comprising a wall that surrounds a bilayer core with exit passageway for communicating with the bilayer core in the wall.

Abstract: A method of making a drug delivery system (10) includes the steps of filling a first water permeable capsule half with a drug and an osmotic agent and plugging an open-end (24) of the capsule (12). The method further includes the steps of disposing a water permeable film (30) over the capsule (12) and plug (28), filling a second capsule half (14) with a drug (18), and releasably mounting an open end (34) of the second capsule half (14) over the plugged end (24) of the first capsule half (12).

Abstract: The present invention relates to a hard capsule made from a material such as gelatin, starch or a hydrophilic polymer. The capsule of the present invention is formulated into a delivery system which incorporates pharmacologically active components in three or more distinct compartments. When three compartments are utilized in the capsule, the outer compartment incorporates a drug and excipients into a layer which coats the outer part of the capsule. This layer represents the rapid release portion of the delivery system. The intermediate compartment comprises a powder formulation comprised of a drug and excipients which represents the intermediary speed release portion of the delivery system. The innermost compartment incorporates the active ingredient or ingredients in a multiparticulate form, such as small pellets, and represents the slow release component of the delivery system.

Abstract: A simulated capsule-like medicament comprising a subcoating of a mixture of a water-soluble, film-forming polymer, e.g. hydroxypropylmethylcellulose and a hydrophobic plasticizer, e.g. castor oil, which promotes a smooth uniform and substantially bubble free outer coating, e.g. gelatin, for the capsule-like medicament; capsule-like medicaments which are slightly bowed in shape; and a process of making such medicaments.

Abstract: Capsules (such as hard gelatin, cellulose and plastic capsules) containing pharmaceutical powders which are administered to a patient via inhalation are treated so as to increase the effective amount of the pharmaceutical agent reaching the respiratory system of the patient. The capsules are coated internally with a lubricant during manufacture and in one aspect, the method involves exposing the lubricant-coated inner surface of the capsule to a pharmaceutically acceptable solvent which dissolves the lubricant. Generally, the solvent is volatile, and bactericidal (e.g. ethanol). The pharmaceutical powder is inserted in the capsule following this washing procedure. Alternatively, the lubricant-coated capsule is dusted internally with a dusting agent such as a salt (e.g. sodium chloride) or a sugar (e.g. lactose, mannitol, trehalose or sucrose) prior to inserting the pharmaceutical powder inside the capsule.

Abstract: An empty medicinal and food capsule includes a cap member containing a cap circumferential slot disposed on the upper portion and at least one raised member disposed on the inner surface thereof, the cap circumferential slot having a triangular slot formed on the outer surface thereof, and a body member containing a body circumferential slot disposed on the upper portion thereof whereby the cap member and the body member can be slidably locked with each other by slidably locking the cap circumferential slot with the body circumferential slot, at the time, the triangular slot prevents from semi-locking or final locking in a prelocking state, and prevents from separating the cap member form the body member in a final locking state, and the capsule is not deformed.

Abstract: An osmotic bursting device for dispensing a beneficial agent to an aqueous environment. The device comprises a beneficial agent and osmagent surrounded at least in part by a semipermeable membrane. Alternatively the beneficial agent may also function as the osmagent. The semipermeable membrane is permeable to water and substantially impermeable to the beneficial agent and osmagent. A trigger means is attached to the semipermeable membrane (e.g., joins two capsule halves). The trigger means is activated by a pH of from 3 to 9 and triggers the eventual, but sudden, delivery of the beneficial agent. These devices enable the pH-triggered release of the beneficial agent core as a bolus by osmotic bursting.

Abstract: The drug consists of a two-part gelatine capsule filled with a non-toxic substance, low on burnable ingrediants, which enlarges its volume when set free in the stomach. The filling can be dissolved within the digestive tract of the human body, e.g. compressed cellulose. The person taking the drug experiences through the volume enlargement in the stomach for a certain time a feeling of fulness, hencely making it easier to lose weight.

Abstract: A capsule contains a unit dose of a medicament and is formed by a small container with a cup-shaped hollow bottom. The bottom has a top portion connected by a flexible strip to a cover of a suitable matching shape. A catch is provided for maintaining the cover on the cup-shaped bottom. The catch is easily operated for opening the capsule containing the unit dose. The capsule cannot be closed again once open.

Abstract: A pharmaceutical tablet containing diltiazem hydrochloride suitable for once daily oral administration comprising by weight not less than 30 percent diltiazem hydrochloride and from 30 percent to 70 percent hydroxypropyl methylcellulose having a number average molecular weight of at least 50,000. A two piece hard gelatin capsule containing a plurality of such tablets.

Abstract: The invention relates to a method for making and administering a blinded oral dosage form and the blinded oral dosage form therefor, used for disguising the identity of tableted medications. The method includes making a blinded oral dosage form by placing a tableted medication within a capsule have a diameter greater than its height. The blinded oral dosage form is the combination of the above-described capsule and the tableted medication.

Abstract: The invention relates to a method for making and administering a blinded oral dosage form and the blinded oral dosage form therefor, used for disguising the identity of tableted medications. The method includes making a blinded oral dosage form by placing a tableted medication within a capsule have a diameter greater than its height. The blinded oral dosage form is the combination of the above-described capsule and the tableted medication.

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: An oral nutritional supplement, i.e., a dietary adjunct, for livestock which includes incompatible live microbial cultures, and vitamin and mineral supplements, each separated from the other via multiple encapsulation. The microbial cultures include gastrointestinal bacteria, yeasts or fungi. A method of delivering incompatible compounds in vivo, a method of preparing shelf-stable compositions of incompatible substances, and a system for delivering oral nutritional supplements to livestock are also provided.

Abstract: The present invention is directed to a fluid-imbibing dispensing device for the extended or protracted delivery of an active agent following an initially delayed startup of the delivery to a fluid environment of use.

Abstract: A tamper-resistant, caplet like medicament that masks the taste of poor tasting drugs and possesses an improved lubricity for easier swallowing is produced by shrinking a gelatin-based capsule about a caplet-shaped tablet of the medicament at specific temperatures, pressure and relative humidity.

Abstract: A tamper-resistant dosage form capsule for the oral administration of therapeutic agents comprises a two-part capsule which is shrunk around a caplet so that the outer wall of the caplet is bound to the inner walls of both parts of the capsule. The caplet is placed into the capsule, and the dosage form is then subjected to relatively high humidity and temperature conditions, followed by drying the dosage form in a lower humidity environment, so that the capsule is shrunk to conform to the contours of the caplet and both parts of the capsule are bonded to the caplet.

Abstract: A hard capsule for pharmaceutical drugs comprises a water-soluble cellulose derivative as a capsule base, a gelatinizing agent and an auxiliary for gelation. The hard capsule is prepared by preparing an aqueous solution of a capsule base containing a water-soluble cellulose derivative, a gelatinizing agent and an auxiliary for gelation, immersing a capsule molding pin in the aqueous solution of the capsule base, subsequently drawing out the molding pin from the aqueous solution of the capsule base, subjecting the aqueous solution of the capsule base attached to the outer surface of the molding pin to gelate at room temperature, and forming a capsule film on the outer surface of the molding pin.

Abstract: There are disclosed herein a gelatin coating composition which comprises succinated gelatin as the main component and polyethylene glycol, and a hard gelatin capsule formed from said gelatin coating composition. The hard gelatin capsule has sufficient mechanical strength for filling operation. Moreover, it does not become insoluble due to reaction with a special drug having an aldehyde group filled therein. Therefore, it can be used for various drugs, especially macrolide antibiotics for which conventional hard gelatin capsules are inadequate.

Abstract: Disclosed is a novel simulated capsule medicament consisting of a solid core covered with two shrink-wrapped, hard-shell gelatin capsule halves. The solid cores are covered with the hard-shell gelatin capsule halves by individually shrink-wrapping onto first one end of the core a first hard-shell gelatin capsule half and then individually shrink-wrapping onto a second end of the core a second hard-shell gelatin capsule half.

Abstract: An osmotic system is disclosed for delivering a beneficial agent formulation to an environment of use. The osmotic system comprises (a) an outside semipermeable wall, (b) a middle osmotically active layer, (c) a capsule comprising a beneficial agent, and (d) a passageway for dispensing the beneficial agent from the osmotic system.

Abstract: A drug delivery system includes a first capsule half having an inner chamber for containing a drug therein. A plug is disposed in a passageway of the capsule half for plugging the opening thereof. The plug is releasable from the passageway opening upon the application of pressure from within the inner chamber. A pump mechanism causes an increase in pressure within the inner chamber and forces the plug out of the passageway to release the drug from the inner chamber and out of the passageway thereby providing a second pulse of drug release at a predetermined time after initial ingestion of the capsule. The invention further provides a method of manufacturing the drug delivery system and method by which the drug delivery system provides the drug to the body.

Abstract: An osmotic bursting device for dispensing a beneficial agent to an aqueous environment. The device comprises a beneficial agent and osmagent surrounded at least in part by a semipermeable membrane. Alternatively the beneficial agent may also function as the osmagent. The semipermeable membrane is permeable to water and substantially impermeable to the beneficial agent and osmagent. A trigger means is attached to the semipermeable membrane (e.g., joins two capsule halves). The trigger means is activated by a pH of from 3 to 9 and triggers the eventual, but sudden, delivery of the beneficial agent. These devices enable the pH-triggered release of the beneficial agent core as a bolus by osmotic bursting.

Abstract: A novel fungicide derived from a neem seed extract comprising neem oil which is substantially free of azadirachtin, said neem oil being prepared by extracting dried, coarsely ground neem seeds with a non-polar, hydrophobic solvent to obtain a neem oil extract, and then removing the solvent to obtain the neem oil. These neem oil fungicides exhibit the ability to control various fungi.

Abstract: Novel devices for the controlled release of active materials especially pharmaceutical are formed from at least two interpenetrating pieces. The male piece is water swellable and swells to disengage the female piece. The female piece is preferably formed from a thermoplastic, e.g. LDPE or from a soluble material such as gelatin which is rendered impermeable by an external coating of a hydrophobic material such as PVC. The devices find particular application as oral dosage forms for use in man.

Abstract: An osmotic system is disclosed for delivering a beneficial agent formulation to an environment of use. The osmotic system comprises (a) an outside semipermeable wall, (b) a middle osmotically active layer, (c) a capsule comprising a beneficial agent, and (d) a passageway for dispensing the beneficial agent from the osmotic system.

Abstract: The invention relates to a method for making and administering a blinded oral dosage form and the blinded oral dosage form therefor, used for disguising the identity of tableted medications. The method includes making a blinded oral dosage form by placing a tableted medication within a capsule have a diameter greater than its height. The blinded oral dosage form is the combination of the above-described capsule and the tableted medication.

Abstract: The present invention is directed to a fluid-imbibing drug delivery device which is useful for the initial delayed delivery of an active agent formulation to a fluid environment of use, the initial delay period to startup or activation being of a predetermined length of time. The delivery of the agent formulation from the dispensing device, once begun, is continued over a predetermined prolonged period of time.

Abstract: An oral nutritional supplement, i.e., a dietary adjunct, for livestock which includes incompatible live microbial cultures, and vitamin and mineral supplements, each separated from the other via multiple encapsulation. A method of delivering incompatible compounds in vivo, a method of preparing shelf-stable compositions of incompatible substances, and a system for delivering oral nutritional supplements to livestock are also provided.

Abstract: A cosmetic product is provided that stores a cosmetic composition in a capsule having a spheroidal body with hollow chamber forming a major portion of the capsule, a tab forming a minor portion of the capsule, and a neck section connecting the tab with the spheroidal body. At least two wings are positioned along opposite sides of the spheroidal body perpendicularly extending outward therefrom. Upon twisting, the neck can be broken to allow release of cosmetic composition from within the chamber.

Abstract: A hard capsule for pharmaceutical drugs comprises a water-soluble cellulose derivative as a capsule base, a gelatinizing agent and an auxiliary for gelation. The hard capsule is prepared by preparing an aqueous solution of a capsule base containing a water-soluble cellulose derivative, a gelatinizing agent and an auxiliary for gelation, immersing a capsule molding pin in the aqueous solution of the capsule base, subsequently drawing out the molding pin from the aqueous solution of the capsule base, subjecting the aqueous solution of the capsule base attached to the outer surface of the molding pin to gelate at room temperature, and forming a capsule film on the outer surface of the molding pin.