Patents by Inventor Manish S. Shah

Manish S. Shah has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).

  • Patent number: 10688055
    Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.
    Type: Grant
    Filed: May 9, 2014
    Date of Patent: June 23, 2020
    Assignee: INSPIRION DELIVERY SCIENCES, LLC
    Inventors: Manish S. Shah, Ray J. DiFalco
  • Patent number: 10688054
    Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.
    Type: Grant
    Filed: March 4, 2011
    Date of Patent: June 23, 2020
    Assignee: INSPIRION DELIVERY SCIENCES LLC
    Inventors: Manish S. Shah, Ray Difalco
  • Patent number: 10688051
    Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.
    Type: Grant
    Filed: March 4, 2011
    Date of Patent: June 23, 2020
    Assignee: INSPIRION DELIVERY SCIENCES LLC
    Inventors: Manish S. Shah, Ray Diflaco
  • Patent number: 10675246
    Abstract: Orally administrable compositions comprising calcium, methods of administration, and methods of making the same.
    Type: Grant
    Filed: March 15, 2014
    Date of Patent: June 9, 2020
    Assignee: CEROLIFE LLC
    Inventors: Manish S. Shah, Ray J. DiFalco
  • Patent number: 10420726
    Abstract: Orally administrable pharmaceutical compositions, methods of administration, and methods of making the same are provided. The pharmaceutical compositions provide abuse deterrent properties.
    Type: Grant
    Filed: March 18, 2014
    Date of Patent: September 24, 2019
    Assignee: INSPIRION DELIVERY SCIENCES, LLC
    Inventors: Manish S. Shah, Ray J. Difalco, Stefan Aigner
  • Publication number: 20190209480
    Abstract: An oral pharmaceutical composition comprising a drug and one or more pharmaceutically acceptable excipients in a monolithic dosage form, wherein the dosage form is configured such that when the dosage form is divided into more than one piece and at least one of the pieces is administered to a subject the Cmax, AUC, and/or rate of drug released after administration is substantially the same or lower and the Tmax is higher than the Cmax, AUC, rate of drug released, and/or Tmax after administration of: (1) a comparable composition in intact dosage form of equal drug dosage of the administered at least one piece; (2) a bioequiva lent drug composition in an intact dosage form of equal drug dosage to the administered at least one piece; and (3) a divided piece of a bioequivalent drug composition, wherein the divided piece comprises a drug dosage equal to the dosage of the administered piece of the oral composition. Methods of making the same and methods of using the same are also provided.
    Type: Application
    Filed: March 21, 2019
    Publication date: July 11, 2019
    Inventors: Manish S. SHAH, Ray J. DIFALCO
  • Patent number: 10314788
    Abstract: An oral pharmaceutical composition comprising a drug and one or more pharmaceutically acceptable excipients in a monolithic dosage form, wherein the dosage form is configured such that when the dosage form is divided into more than one piece and at least one of the pieces is administered to a subject the Cmax, AUC, and/or rate of drug released after administration is substantially the same or lower and the Tmax is higher than the Cmax, AUC, rate of drug released, and/or Tmax after administration of: (1) a comparable composition in intact dosage form of equal drug dosage of the administered at least one piece; (2) a bioequivalent drug composition in an intact dosage form of equal drug dosage to the administered at least one piece; and (3) a divided piece of a bioequivalent drug composition, wherein the divided piece comprises a drug dosage equal to the dosage of the administered piece of the oral composition. Methods of making the same and methods of using the same are also provided.
    Type: Grant
    Filed: February 12, 2009
    Date of Patent: June 11, 2019
    Assignee: INSPIRION DELIVERY SCIENCES LLC
    Inventors: Manish S. Shah, Ray J. Difalco
  • Publication number: 20180082553
    Abstract: The present disclosure provides devices, systems and methods for monitoring unauthorized access into a container or bottle, and alerting the authorized user, or someone designated by the authorized user, of any unauthorized access.
    Type: Application
    Filed: June 3, 2016
    Publication date: March 22, 2018
    Inventors: Richard J. DIFALCO, Manish S. SHAH
  • Publication number: 20160106764
    Abstract: The present invention is directed to a pharmaceutical composition in unit dose form for orally delivering doxycycline to a human, the pharmaceutical composition comprising: a capsule, wherein the capsule is coated with a delayed release layer; wherein the delayed release layer comprises about 4 to 6 mg of doxycycline monohydrate and a binding agent, and wherein the delayed release layer is coated with an enteric coating; wherein the enteric coating dissolves at pH of about 5 to 6, and wherein the enteric coating is coated with an immediate release layer; wherein the immediate release layer comprises about 32 mg of doxycycline monohydrate and a binding agent, wherein the relative mean Cmax of the pharmaceutical composition is within 80.00% to 125.00% of a Cmax value of 510±220.7 ng/mL, after administration of a single dose of the pharmaceutical composition to humans in a fasting state; and wherein the relative mean AUC(0-?) of the pharmaceutical composition is within 80.00% to 125.
    Type: Application
    Filed: December 29, 2015
    Publication date: April 21, 2016
    Inventors: Jean-Pierre Etchegaray, Nathalie Wagner, Manish S. Shah, Ray J. Difalco
  • Publication number: 20160074383
    Abstract: Orally administrable pharmaceutical compositions and methods of administration are provided. The pharmaceutical compositions provide abuse deterrent properties.
    Type: Application
    Filed: September 15, 2014
    Publication date: March 17, 2016
    Inventors: Manish S. Shah, Ray J. DiFalco, Stefan Aigner
  • Publication number: 20160022586
    Abstract: Orally administrable compositions comprising calcium, methods of administration, and methods of making the same.
    Type: Application
    Filed: March 15, 2014
    Publication date: January 28, 2016
    Inventors: Manish S. Shah, Ray J. DiFalco
  • Publication number: 20150245998
    Abstract: The present invention is directed to a pharmaceutical composition in unit dose form for orally delivering doxycycline to a human, the pharmaceutical composition comprising: a capsule, wherein the capsule is coated with a delayed release layer; wherein the delayed release layer comprises about 4 to 6 mg of doxycycline monohydrate and a binding agent, and wherein the delayed release layer is coated with an enteric coating; wherein the enteric coating dissolves at pH of about 5 to 6, and wherein the enteric coating is coated with an immediate release layer; wherein the immediate release layer comprises about 32 mg of doxycycline monohydrate and a binding agent, wherein the relative mean Cmax of the pharmaceutical composition is within 80.00% to 125.00% of a Cmax value of 510±220.7 ng/mL, after administration of a single dose of the pharmaceutical composition to humans in a fasting state; and wherein the relative mean AUC(0-?) of the pharmaceutical composition is within 80.00% to 125.
    Type: Application
    Filed: May 13, 2015
    Publication date: September 3, 2015
    Inventors: Jean-Pierre Etchegaray, Nathalie Wagner, Manish S. Shah, Ray J. Difalco
  • Publication number: 20150104505
    Abstract: Pharmaceutical compositions in unit dose form comprising a hard or soft capsule containing a fill consisting of one or more inert ingredients, and one or more coatings on the capsule, wherein at least one coating comprises at least one active pharmaceutical ingredient.
    Type: Application
    Filed: September 30, 2014
    Publication date: April 16, 2015
    Inventors: Manish S. SHAH, Ray J. DiFalco
  • Publication number: 20150071995
    Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.
    Type: Application
    Filed: November 7, 2014
    Publication date: March 12, 2015
    Inventors: Manish S. Shah, Ray J. DiFalco
  • Publication number: 20150071998
    Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.
    Type: Application
    Filed: November 7, 2014
    Publication date: March 12, 2015
    Inventors: Manish S. Shah, Ray J. DiFalco
  • Publication number: 20150064245
    Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.
    Type: Application
    Filed: November 7, 2014
    Publication date: March 5, 2015
    Inventors: Manish S. Shah, Ray J. DiFalco
  • Publication number: 20150064247
    Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.
    Type: Application
    Filed: November 7, 2014
    Publication date: March 5, 2015
    Inventors: Manish S. Shah, Ray J. DiFalco
  • Publication number: 20150064248
    Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.
    Type: Application
    Filed: November 7, 2014
    Publication date: March 5, 2015
    Inventors: Manish S. Shah, Ray J. DiFalco
  • Publication number: 20150064246
    Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.
    Type: Application
    Filed: November 7, 2014
    Publication date: March 5, 2015
    Inventors: Manish S. Shah, Ray J. DiFalco
  • Publication number: 20150044282
    Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.
    Type: Application
    Filed: September 23, 2014
    Publication date: February 12, 2015
    Inventors: Manish S. SHAH, Ray J. DiFalco