Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Patent
1993-02-03
1999-03-02
Venkat, Jyothsna
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
424461, 424464, 424465, 424468, 424480, 424481, 424489, 424499, A61K 936
Patent
active
058767525
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
Interfacially-polymerized (IF) membranes which consist of a very thin, dense film are typically coated on a thick porous substrate and are used extensively in the reverse-osmosis desalination of brine. The technology for the formation of economically feasible IF membranes for reverse osmosis was developed by Cadotte et al. and continues to be improved. (Cadotte, J. E., R. S. King, R. J. Majerle, and R. J. Petersen, "Interfacial synthesis in the preparation of reverse osmosis membranes," J. Macromol. Sci.-Chem. A15, 727, 1981)
IF membranes made with siloxanes, alkoxsilyls, or aryloxysilylys have been employed in the separation of gaseous mixtures. (U.S. Pat. No. 4,781,733 "Semipermeable Thin-Film Membranes Comprising Siloxane, Alkoxsilyl, and Aryloxysilyl Oligimers and Copolymers," Bend Research, Inc. Nov. 1, 1989)
IF membranes have also been used to form microcapsules for the controlled release of active ingredients. Several patents have been issued in this area over the past 25 years. A partial list of patented IF microcapsule processes and/or formulations is included in Table 1. Typically these IF microcapsules have been used to facilitate controlled-release pesticide formulations, releasing encapsulated active ingredient by diffusion through the microcapsule walls or by the rupture of the microcapsules.
While the literature is replete with description of tablets, capsules, and multiparticulates which deliver active substances by diffusion or osmotic pumping, none have taught the use of delivering active substances from tablets, capsules, or multiparticulates coated with an IF membrane.
TABLE 1
U.S. Patents Utilizing Interfacially-Polymerized Membranes to Make
Microcapsules
Patent Number--Company--Patent Title
for Making Capsules by Interfacial Polymerization Polycondensation Microcapules by Interfacial Crosslinking of Emulsifier and Microcapsules Produced Thereby Co.--Microcapsule Insecticide Composition; Polyurea Shell, Pyrethroid, Antioxidant, Stabilizer, Solvent, Synergist Interfacial Polycondensation; Microcapsules Containing Agricultural Chemicals Microcapsules and Their Production; Polyureas, Polyurethanes Encapsulating Herbicides and Insecticides
SUMMARY OF THE INVENTION
It has now been found that a device for controlled release of one or more active substances into an environment of use, said device comprising a core of said substances, with or without one or more excipients, surrounded by a porous substructure and one or more IF membranes is feasible and practical.
A preferred feature of the device is a membrane to which is permeable and imperforate and where the release is either substantially by osmotic pumping or substantially by diffusion.
A second preferred feature of the device is a membrane which is permeable and perforate and where the release is either substantially by osmotic pumping or substantially by diffusion.
A third preferred feature is a device in which the IF membrane is a polymer such as polyamide, polyurea, polyester, or polyurethane formed by a condensation reaction.
A fourth preferred feature is a device in the form of a tablet, capsule or bead.
A fifth preferred feature is a device having a membrane which is semipermeable and imperforate, where the release is substantially by osmotic pumping and the device is in the form of a capsule, tablet or bead.
The present invention also includes a tablet, capsule or bead for administration to a mammal which releases one or more pharmaceutically active substances into said animal over an appreciable time interval which comprises a core of said active substance or substances, with or without one or more pharmaceutically acceptable excipients, said core being surrounded by a porous substructure and one or more IF membranes.
A preferred feature is a tablet, capsule or bead, wherein the administration is oral and the release is into the fluid of the gastrointestinal tract of said animal.
Preferred is a tablet, capsule or bead wherein the active substance is an antihypertensive agent. Especially p
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Herbig Scott Max
Korsmeyer Richard Wilker
Thombre Avinash Govind
Benson Gregg C.
Jones James T.
Pfizer Inc.
Richardson Peter C.
Venkat Jyothsna
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