Emisphere Technologies, Inc.

Novartis Ag

Patheon Softgels Inc.

Novo Nordisk North America Operations A/s

Shingai Majuru

Halina Levchik

Brahma N Singh

Michael M Goldberg

William Elliott Bay

JoAnne P Corvino

Satej Bhandarkar

Jamila Harris

Nikhil Dhoot

Steven Minh Dinh

Simon David Bateman

Rajesh K Agarwal

Joseph Ault

Joseph Sikora

Subash Patel

Rebecca F Yang

Joseph Zielinski

Kiran Chaudhary

Moise Azria

William Elliot Bay

Doris C O'Toole

Aqeel A Fatmi

Tatyana Dyakonov

Ehud Arbit

Saujanya L Gosangari

Halina Leuchyk

Moses O Oyewumi

Derek Bush

Navnit Hargovindas Shah

Wantanee Phuapradit

Jun Liao

Chue Yang

Martin Howard Infeld

Puchun Liu

Bruce Variano

Lewis H Bender

John J Weidner

Hashim Ahmed

Zhongshui Yu

JoAnne P Russo

Mosise Azria

Mehmet Tahir Gurler

Lynn Sheilds

Lynn Shields

Amy C Adams

Yang Hue Chue

Michael Goldberg

Doris C O'toole

Joanne P Corvino

Bruce F Variano

Joanne P Russo

Joseph Murray Ault

Joseph L Zielinski

Rebecca Fai-Ying Yang

Prateek N Bhargava

Amy Adams

The present invention relates to crystalline polymorphic forms of monosodium N-[8-(2-hydroxybenzoyl)amino] caprylate ('SNAC'), including two hydrates, a methanol solvate, and an ethanol solvate, of SNAC. More specifically, the present invention provide six polymorphic forms of SNAC (hereafter referred to as Forms I-V). The present invention also provides an amorphous form of SNAC.

Crystalline polymorphic forms of monosodium n-[-8-(2-hydroxybenzoyl)amino]caprylate

The present invention relates to crystalline polymorphic forms of monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate ('SNAC'), including two hydrates, a methanol solvate, and an ethanol solvate, of SNAC. More specifically, the present invention provide six polymorphic forms of SNAC (hereafter referred to as Forms I-VI). The present invention also provides an amorphous form of SNAC.

Crystalline polymorphic forms of monosodium N-[-8-(2-hydroxybenzoyl)amino]caprylate

A hard or soft capsule is disclosed comprising a shell and a fill material, wherein the shell comprises an interpenetrating network comprising a silk polymer and a film-forming natural polymer. A method of making a hard or soft capsule is also disclosed, comprising dissolving a silk protein in a solvent system to form a solubilized silk protein solution; mixing the solubilized silk protein solution with a film-forming natural polymer to form a homogenous shell material; and encapsulating a fill material with the homogenous shell material.

Silk-based capsules

The present invention provides novel solid pharmaceutical dosage forms for oral administration comprising a bisphosphonate, or a pharmaceutically acceptable salt thereof, which bisphosphonate is present in an amount not therapeutically effective when the bisphosphonate is orally administered alone, and a modified amino acid carrier, or a pharmaceutically acceptable salt thereof, which modified amino acid carrier is present in an amount effective to facilitate absorption of the bisphosphonate in the gastrointestinal tract such that the bisphosphonate is therapeutically effective. The ratio of bisphosphonate to modified amino acid carrier is from about 1:30 to about 1:1, respectively. These novel solid pharmaceutical dosage forms are useful in the treatment or control of bone diseases and particular disorders in calcium metabolism, including, for example, osteoporosis, hypercalcaemia of cancer, and the treatment of metastatic bone pain. The present invention also provides a method for treating these diseases employing the solid pharmaceutical dosage forms and a method for preparing the pharmaceutical dosage forms.

Solid pharmaceutical dosage forms comprising bisphosphonates and modified amino acid carriers

The present invention relates to stable pharmaceutical formulations that include a delivery agent and/or pharmaceutically acceptable salt thereof.

Gallium nitrate formulations

The present invention relates to crystalline polymorphic forms of the di-sodium salt of N-(5-chlorosalicyloyl)-8-aminocaprylic acid, pharmaceutical compositions containing the same, methods of preparing the same, and methods for facilitating the delivery of active agents with the same.

Crystalline forms of the di-sodium salt of N-(5-chlorosalicyloyl)-8-aminocaprylic acid

Methods for treating impaired glucose tolerance and early and late stage diabetes in mammals, for prophylactically sparing &#x3b2;-cell function, aiding in preventing &#x3b2;-cell death, preventing the onset of overt diabetes in a mammal with type 2 diabetes, treating the current level of glycemic control dysfunction of a mammal with impaired glucose tolerance or diabetes, comprising orally administering insulin and a delivery agent that facilitates insulin absorption from the gastrointestinal tract at the time of or shortly before mealtime, e.g., within about 10 minutes prior to ingestion of a meal, on a chronic basis. The methods also comprise, in addition to administering a rapid-acting insulin to provide a first insulin peak, administering a slow acting insulin to provide a second insulin peak occurring at a later time but of a longer duration. These methods achieve improved glycemic control without the risks of hypoglycemia, hyperinsulinemia and weight gain and the need for frequent blood glucose monitoring that are normally associated with insulin therapy.

Oral insulin therapies and protocol

The present invention relates to an acyclovir formulation having improved bioavailability resulting in better efficacy and/or requiring less frequent administration.

Acyclovir formulations

Oral insulin formulations and processes for preparing oral insulin formulations are provided.

Formulations for delivering insulin

The inventors have discovered that the disodium salt of certain delivery agents has surprisingly greater efficacy for delivering active agents than the corresponding monosodium salt. Furthermore, the inventors have discovered that the disodium salts of these delivery agents form solvates with ethanol and hydrates with water. Preferred delivery agents include, but are not limited to, N-(5-chlorosalicyloyl)-8-aminocaprylic acid (5-CNAC), N-(10-[2-hydroxybenzoyl]amino)decanoic acid (SNAD), and sodium N-(8-[2-hydroxybenzoyl]amino)caprylate (SNAC). The invention also provides methods of preparing the disodium salt, ethanol solvate, and hydrate and compositions containing the disodium salt, ethanol solvate, and/or hydrate.

Disodium salts, monohydrates, and ethanol solvates for delivering active agents

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Brewster, NY, United States of America

Shingai Majuru