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).

  • Publication number: 20150017240
    Abstract: An oral pharmaceutical composition in unit dosage form comprising: (1) a first portion comprising: an active ingredient and a pH-dependent component, and (2) a second portion comprising a pH-raising agent is provided. Methods of administering the composition are also provided.
    Type: Application
    Filed: September 26, 2014
    Publication date: January 15, 2015
    Inventors: Manish S. Shah, Ray J. DiFalco
  • Publication number: 20150005334
    Abstract: Orally administrable pharmaceutical compositions, methods of administration, and methods of making the same are provided. The pharmaceutical compositions provide abuse deterrent properties.
    Type: Application
    Filed: September 12, 2014
    Publication date: January 1, 2015
    Inventors: Manish S. SHAH, Ray J. DiFalco, Stefan Aigner
  • Publication number: 20140377352
    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 12, 2014
    Publication date: December 25, 2014
    Inventors: Manish S. Shah, Ray J. DiFalco
  • Publication number: 20140271898
    Abstract: Orally administrable pharmaceutical compositions, methods of administration, and methods of making the same are provided. The pharmaceutical compositions provide abuse deterrent properties.
    Type: Application
    Filed: March 18, 2014
    Publication date: September 18, 2014
    Applicant: Inspirion Delivery Technologies, LLC
    Inventors: Manish S. Shah, Ray J. DiFalco, Stefan Aigner
  • Publication number: 20140275149
    Abstract: Orally administrable pharmaceutical compositions, methods of administration, and methods of making the same are provided. The pharmaceutical compositions provide abuse deterrent properties.
    Type: Application
    Filed: March 18, 2014
    Publication date: September 18, 2014
    Applicant: Inspirion Delivery Technologies, LLC
    Inventors: Manish S. Shah, Ray J. DiFalco, Stefan Aigner
  • Publication number: 20140275150
    Abstract: Orally administrable pharmaceutical compositions, methods of administration, and methods of making the same are provided. The pharmaceutical compositions provide abuse deterrent properties.
    Type: Application
    Filed: March 18, 2014
    Publication date: September 18, 2014
    Applicant: Inspirion Delivery Technologies, LLC
    Inventors: Manish S. Shah, Ray J. DiFalco, Stefan Aigner
  • Publication number: 20140271845
    Abstract: Pharmaceutical compositions in unit dose form comprising a hollow substrate and one or more coatings on the hollow substrate, wherein at least one coating comprises at least one active pharmaceutical ingredient, and methods of making the same are provided.
    Type: Application
    Filed: March 18, 2014
    Publication date: September 18, 2014
    Applicant: Cerovene, Inc.
    Inventors: Manish S. SHAH, Ray J. DiFalco
  • Publication number: 20140275148
    Abstract: Orally administrable, self-supporting, dissolving film dosage forms comprising an active ingredient and a polyvinyl alcohol-polyethylene glycol graft copolymer, and methods of orally administering the film dosage forms are provided.
    Type: Application
    Filed: March 18, 2014
    Publication date: September 18, 2014
    Applicant: Novus Pharma LLC
    Inventors: Manish S. SHAH, Ray J. DiFalco
  • Publication number: 20140275038
    Abstract: Orally administrable pharmaceutical compositions, methods of administration, and methods of making the same are provided. The pharmaceutical compositions provide abuse deterrent properties.
    Type: Application
    Filed: March 18, 2014
    Publication date: September 18, 2014
    Applicant: Inspirion Delivery Technologies, LLC
    Inventors: Manish S. Shah, Ray J. DiFalco, Stefan Aigner
  • Publication number: 20140271834
    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: October 16, 2013
    Publication date: September 18, 2014
    Applicants: Cerovene, Inc., Galderma S.A.
    Inventors: Jean-Pierre Etchegaray, Nathalie Wagner, Manish S. Shah, Ray J. Difalco
  • Publication number: 20140275039
    Abstract: Orally administrable pharmaceutical compositions, methods of administration, and methods of making the same are provided. The pharmaceutical compositions provide abuse deterrent properties.
    Type: Application
    Filed: March 18, 2014
    Publication date: September 18, 2014
    Applicant: Inspirion Delivery Technologies, LLC
    Inventors: Manish S. Shah, Ray J. DiFalco, Stefan Aigner
  • Publication number: 20140248344
    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: May 9, 2014
    Publication date: September 4, 2014
    Applicant: lnspirion Delivery Technologies, LLC
    Inventors: Manish S. SHAH, Ray J. DiFalco
  • Publication number: 20140248343
    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: May 9, 2014
    Publication date: September 4, 2014
    Applicant: Inspirion Delivery Technologies, LLC
    Inventors: Manish S. SHAH, Ray J. DiFalco
  • Patent number: 8652516
    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: Grant
    Filed: June 27, 2013
    Date of Patent: February 18, 2014
    Assignees: Cerovene, Inc., Galderma S.A.
    Inventors: Jean-Pierre Etchegaray, Nathalie Wagner, Manish S. Shah, Ray J. Difalco
  • Publication number: 20120244216
    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: June 7, 2012
    Publication date: September 27, 2012
    Inventors: Manish S. SHAH, Ray J. Difalco
  • Publication number: 20120164209
    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: February 29, 2012
    Publication date: June 28, 2012
    Applicant: INSPIRION DELIVERY TECHNOLOGIIES, LLC
    Inventors: Manish S. Shah, Ray Difalco
  • Publication number: 20120156277
    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: February 29, 2012
    Publication date: June 21, 2012
    Applicant: INSPIRION DELIVERY TECHNOLOGIES, LLC
    Inventors: Manish S. Shah, Ray J. Difalco
  • Publication number: 20110245967
    Abstract: The present invention is generally directed to a method of dispensing regulated items, particularly drugs, directly to the patient via a dispensing system, without pharmacist intervention, that reduces human error associated with dispensing regulated items wherein a manufacturer or distributor of a regulated item establishes a dispensing system in communication with a data base wherein a prescriber is registered and enters patient data such as which regulated item is prescribed for the patient, characteristics such as sex, age, height, weight, etc., any other drugs the patient is currently taking or has a prescription for, any allergies to any particular drugs, substances, components, etc.
    Type: Application
    Filed: April 6, 2010
    Publication date: October 6, 2011
    Inventors: Manish S. Shah, Ray J. Difalco
  • Publication number: 20110184007
    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: Application
    Filed: February 12, 2009
    Publication date: July 28, 2011
    Applicant: INSPIRION DELIVERY TECHNOLOGIES, LLC
    Inventors: Manish S. Shah, Ray J. Difalco
  • Publication number: 20110159090
    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: March 4, 2011
    Publication date: June 30, 2011
    Applicant: INSPIRION DELIVERY TECHNOLOGIES, LLC
    Inventors: Manish S. SHAH, Ray Difalco