Abstract: A high dose rapidly dispersing three-dimensionally printed dosage form comprising a high dose of water soluble drug in a porous matrix that disperses in water within a period of less than about 15 seconds is disclosed. Also disclosed are methods of preparing the dosage form and of treating a condition, disease or disorder that is therapeutically responsive to the drug.

Abstract: A taste-masked rapidly dispersible dosage form of topiramate is provided. Wax coated particles of topiramate are included within a porous bound matrix. The topiramate retains its taste-masked form after dispersion in the mouth of a subject even though the particles are not coated with a polymeric material. The dosage form disperses in saliva or water in less than 2 min even though it has a high content of wax. It can be used to treat diseases or disorders that are therapeutically responsive to topiramate or a derivative thereof.

Abstract: A high dose rapidly dispersing three-dimensionally printed dosage form comprising a high dose of levetiracetam in a porous matrix that disperses in water within a period of less than about 15 seconds is disclosed. Also disclosed are methods of preparing the dosage form and of treating a condition, disease or disorder that is therapeutically responsive to levetiracetam.

Abstract: A taste-masked rapidly dispersible dosage form of topiramate is provided. Wax coated particles of topiramate are included within a porous bound matrix. The topiramate retains its taste-masked form after dispersion in the mouth of a subject even though the particles are not coated with a polymeric material. The dosage form disperses in saliva or water in less than 2 min even though it has a high content of wax. It can be used to treat diseases or disorders that are therapeutically responsive to topiramate or a derivative thereof.

Abstract: A rapidly dispersing dosage form is described. The dosage form releases its active ingredients within a period of less than about ninety seconds. These dosage forms exhibit a three-dimensional shape that is retained for adequate storage but is readily dispersed in the presence of excess moisture. Also disclosed are methods of administration of a medicament and a process for the preparation of rapidly dispersing dosage forms.

Abstract: A high dose rapidly dispersing three-dimensionally printed dosage form comprising a high dose of levetiracetam in a porous matrix that disperses in water within a period of less than about 10 seconds is disclosed. Also disclosed are methods of preparing the dosage form and of treating a condition, disease or disorder that is therapeutically responsive to levetiracetam.

Abstract: A rapidly dispersing dosage form is described, which releases its active ingredients within a period of less than about ninety seconds. These dosage forms exhibit a three-dimensional shape that is retained for adequate storage but is readily dispersed in the presence of excess moisture. Also disclosed are methods of administration of a medicament and a process for the preparation of rapidly dispersing dosage forms.

Abstract: Pharmaceutical dosage forms with external or internal features to complicate counterfeiting and support authentication are described. External features include surface texture, surface markings defined by patterns of physical or chemical markers, or complex interlocking shapes. Internal features also include physical or chemical markers in two or three-dimensional patterns observable after sectioning, or after breaking along designed fracture lines. Methods of manufacture using solid freeform fabrication (SFF) techniques such as three-dimensional printing (3DP) are described. Method of authentication using dosage form patterns and batch codes are also described.

Abstract: A drug delivery device such as an oral dosage form (ODF) with a toxic or potent core encapsulated by a non-toxic region. The non-toxic region may be a region including multiple layers, coatings, shells, and combinations thereof, which provides protection to and isolation from the toxic or potent core. The drug in the toxic or potent core is incorporated into the dosage form via, for example, three-dimensional printing, as a solution, solubilization or suspension of solid particles in liquid, rather than by the more conventional handling and compressing of dry powder. This minimizes the likelihood of creating airborne particles of the toxic drug during manufacturing, hence controlling and minimizing the exposure of manufacturing personnel to the hazardous substance. Wet dispensing of the toxic or potent drug further provides greater bioavailability of the drug to the patient.

Abstract: A drug delivery device such as an oral dosage form (ODF) with a toxic or potent core encapsulated by a non-toxic region. The non-toxic region may be a region including multiple layers, coatings, shells, and combinations thereof, which provides protection to and isolation from the toxic or potent core. The drug in the toxic or potent core is incorporated into the dosage form via, for example, three-dimensional printing, as a solution, solubilization or suspension of solid particles in liquid, rather than by the more conventional handling and compressing of dry powder. This minimizes the likelihood of creating airborne particles of the toxic drug during manufacturing, hence controlling and minimizing the exposure of manufacturing personnel to the hazardous substance. Wet dispensing of the toxic or potent drug further provides greater bioavailability of the drug to the patient.

Abstract: A method and apparatus for controlling the migration of binder liquid in a bulk powder. The bulk powder may be deposited in a powder bed and contains at least two different substances, each in powder form. One substance gives the printed part its bulk properties, forms most of the powder, and preferably is either insoluble or not significantly soluble in the binder liquid. The other powder substance is a migration control substance. Upon interaction with the binder liquid, this substance may absorb the binder liquid and form a gel or dissolve into the binder liquid increasing viscosity thereby inhibiting binder migration. No chemical reactions occur between the binder liquid and any of the substances in the powder bed. In another embodiment of the instant invention, binder migration may be further controlled by first printing a barrier region in the powder bed containing the migration control substance.

Abstract: A fabrication method to rapidly fabricate different prototypes of drug delivery systems, medical devices, pharmaceutical dosage forms, tissue scaffolds or other bioaffecting agents in small batches or individual forms using a computer-guided system to vary the composition and structure in order to optimize the product and the manufacturing process. The process is immediately scalable. An Expert System can be used with the method to recommend different compositions and designs of the prototypes, devices, dosage forms, tissue scaffold or other bioaffecting agents.

Abstract: A rapidly dispersing dosage form is described, which releases its active ingredients within a period of less than about ninety seconds. These dosage forms exhibit a three-dimensional shape that is retained for adequate storage but is readily dispersed in the presence of excess moisture. Also disclosed are methods of administration of a medicament and a process for the preparation of rapidly dispersing dosage forms.

Abstract: A fabrication method to rapidly fabricate different prototypes of drug delivery systems, medical devices, pharmaceutical dosage forms, tissue scaffolds or other bioaffecting agents in small batches or individual forms using a computer-guided system to vary the composition and structure in order to optimize the product and the manufacturing process. The process is immediately scalable. An Expert System can be used with the method to recommend different compositions and designs of the prototypes, devices, dosage forms, tissue scaffold or other bioaffecting agents.

Abstract: A rapidly dispersing dosage form is described, which releases its active ingredients within a period of less than about ninety seconds. These dosage forms exhibit a three-dimensional shape that is retained for adequate storage but is readily dispersed in the presence of excess moisture. Also disclosed are methods of administration of a medicament and a process for the preparation of rapidly dispersing dosage forms.

Abstract: A drug delivery device such as an oral dosage form (ODF) with a toxic or potent core encapsulated by a non-toxic region. The non-toxic region may be a region including multiple layers, coatings, shells, and combinations thereof, which provides protection to and isolation from the toxic or potent core. The drug in the toxic or potent core is incorporated into the dosage form via, for example, three-dimensional printing, as a solution, solubilization or suspension of solid particles in liquid, rather than by the more conventional handling and compressing of dry powder. This minimizes the likelihood of creating airborne particles of the toxic drug during manufacturing, hence controlling and minimizing the exposure of manufacturing personnel to the hazardous substance. Wet dispensing of the toxic or potent drug further provides greater bioavailability of the drug to the patient.

Abstract: The crystalline anhydrous form of [3S-[3.alpha.(Z), 4.beta.]]-3-[[(2-amino-4-thiazolyl) [(1-carboxy-1-methylethoxy)imino]acetyl]amino]-4-methyl-2-oxo-1-azetidines ulfonic acid is prepared.

Abstract: A steroid formulation is provided which is preferably in the form of a lotion or cream and contains a steroid, such as halcinonide, a polyol vehicle therefor, such as polyethylene glycol, and dipotassium ethylenediaminetetraacetic acid which is soluble in the polyol vehicle and inhibits metal catalyzed degradation of the steroid.

Abstract: A lyophilized pharmaceutical composition comprising a prostaglandin of the E-series and an excipient selected from the group consisting of sodium chloride, cyclodextrin, succinic acid and polyvinylpyrrolidone.

Abstract: A lyophilized pharmaceutical composition comprising a prostaglandin of the E-series and an excipient selected from the group consisting of sodium chloride, cyclodextrin, succinic acid and polyvinylpyrrolidone.