Abstract: A lyophilization promoting element to facilitate the transfer of heat between a lyophilizer and a pre-lyophilization solution. The element includes a base plate with a plurality of apertures. The base plate is made of a thermally conductive material and the apertures are regularly arranged within the base plate, each aperture being sized to receive a pharmaceutical vial container containing a pre-lyophilization solution. A method of lyophilizing includes inserting one or more pharmaceutical vial containers into the plurality of apertures of the lyophilization promoting element and placing the lyophilization promoting element holding the one or more pharmaceutical vial containers on a shelf of a lyophilizer.
Type:
Grant
Filed:
April 14, 2021
Date of Patent:
August 22, 2023
Assignee:
Navinta III Inc
Inventors:
Mahendra R. Patel, Sandipkumar Arvindbhai Patel
Abstract: Processes that use novel reagents for the removal of colored impurity during the preparation of Salcaprozic Acid and pharmaceutically acceptable salts thereof. The processes include hydrolysis of 8-(2,4-dioxo-1,3-benzoxazin-3-yl)octanoic acid ethyl ester in the presence of or by contacting it with benzotriazole, hydrazine and/or sodium borohydride.
Type:
Grant
Filed:
April 13, 2022
Date of Patent:
June 6, 2023
Assignee:
Navinta III Inc.
Inventors:
Pankaj Vasudev Parmar, Raja Jeyakumar John Muthiah, Vikas Kantilal Chauhan, Jagdish Kanjibhai Solanki
Abstract: Solid compositions having about 150 mg to about 245 mg Fosaprepitant that are stable after storage at about 25° C. for 6 months and processes for preparing solid Fosaprepitant compositions that are stable after long term storage at room temperature. The processes include freezing a Fosaprepitant solution in the primary packaging container at a first freezing temperature; applying vacuum at second temperature that is higher than the freezing temperature; fully stoppering the primary packaging container; and sealing the stoppered primary packaging container.
Abstract: A lyophilization promoting element to facilitate the transfer of heat between a lyophilizer and a pre-lyophilization solution. The element includes a base plate with a plurality of apertures. The base plate is made of a thermally conductive material and the apertures are regularly arranged within the base plate, each aperture being sized to receive a pharmaceutical vial container containing a pre-lyophilization solution. A method of lyophilizing includes inserting one or more pharmaceutical vial containers into the plurality of apertures of the lyophilization promoting element and placing the lyophilization promoting element holding the one or more pharmaceutical vial containers on a shelf of a lyophilizer.
Type:
Application
Filed:
April 14, 2021
Publication date:
October 21, 2021
Applicant:
Navinta III Inc
Inventors:
Mahendra R. Patel, Sandipkumar Arvindbhai Patel
Abstract: The present invention provides pharmaceutical formulations of lyophilized carmustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized carmustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with carmustine, such as neoplastic diseases.
Abstract: Solid compositions having about 150 mg to about 245 mg Fosaprepitant that are stable after storage at about 25° C. for 6 months and processes for preparing solid Fosaprepitant compositions that are stable after long term storage at room temperature. The processes include freezing a Fosaprepitant solution in the primary packaging container at a first freezing temperature; applying vacuum at second temperature that is higher than the freezing temperature; fully stoppering the primary packaging container; and sealing the stoppered primary packaging container.
Abstract: The present invention provides pharmaceutical formulations of lyophilized carmustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized carmustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with carmustine, such as neoplastic diseases.
Abstract: A kit for treating psychosis by administering a pharmaceutically acceptable liquid composition of Asenapine to oral mucosa includes a formulation having Asenapine, or a pharmaceutically acceptable salt or hydrate thereof, ethanol, and water and a multidose pump filled with the formulation. The Asenapine compositions are stable for an extended period of time at normal storage conditions.