Massachusetts Institute of Technology

Therics, Inc.

Aprecia Pharmaceuticals Company

Aprecia Pharmaceuticals LLC

Donald C. Monkhouse

Jill K. Sherwood

Jaedeok Yoo

Michael Cima

Donald C Monkhouse

Thomas George West

Henry Leon Surprenant

Jules S Jacob

Sandeep Kumar

Nemichand B Jain

Norman Coyle

Michael John Cima

Christopher M Gaylo

Chen-Chao Wang

Jill K Sherwood

Francis C Payumo

Lauren Beach

Qing Wen Liu

Peter A Materna

Thomas J Bradbury

Charles William Rowe

Timothy J Pryor

Esteban Bornancini

Alfred Anthony Litwak

Sunil Saini

Kathleen D Chesmel

Heather Ann Beam

Jennifer Patterson

Jae D Yoo

Henry L Surprenant

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.

Rapid disperse dosage form

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.

Rapidly dispersible dosage form of topiramate

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.

Rapid disperse dosage form containing levetiracetam

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.

Dosage form exhibiting rapid disperse properties, methods of use and process for the manufacture of same

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.

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.

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.

Dosage forms and methods of use thereof

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.

Method and form of a drug delivery device, such as encapsulating a toxic core within a non-toxic region in an oral dosage form

An engineered regenerative biostructure (erb) for implantation into a human body as a bone substitute, which includes an internal microstructure, mesostructure and/or macrostructure to provide improved bone in-growth, and methods for making the erb. Under one aspect of the invention, the biostructure has resorbable and nonresorbable regions. Under another aspect of the invention, the biostructure is constructed of hydroxyapatite, tricalcium phosphate and/or demineralized bone. Under yet another aspect of the invention, the porous biostructure is partially or fully infused with a resorbable, nonresorbable or dissolvable material.

Method and apparatus for engineered regenerative biostructures such as hydroxyapatite substrates for bone healing applications

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.

Rapid prototyping and manufacturing process

Dosage forms prepared by solid free form fabrication (SFF) provide release of medicament in multiple phases.

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Radnor, PA, United States of America

Donald C Monkhouse