Investigation of effectiveness of inhalation intake of beta-caryophyllene (BCP) against vascular wall stiffening caused by smoking. - Investigation of effectiveness of inhalation intake of beta-caryophyllene (BCP) against vascular wall stiffening caused by smoking.

Start Date10 Dec 2022

Sponsor / Collaborator

Sunsho Pharmaceutical Co., Ltd.

JPRN-UMIN000048512 / Completed

Blood transfer confirmation test of beta-caryophyllene by single inhalation ingestion associated with smoking of beta-caryophyllene - Blood transfer confirmation test of beta-caryophyllene by single inhalation ingestion associated with smoking of beta-caryophyllene

Start Date01 Dec 2021

Sponsor / Collaborator

Sunsho Pharmaceutical Co., Ltd.

JPRN-UMIN000048510 / Completed

Randomized controlled trials to verify that inhalation of beta-caryophyllene improves vascular wall hardening and lowers baPWV - Randomized controlled trials to verify that inhalation of beta-caryophyllene improves vascular wall hardening and lowers baPWV

Start Date01 Sep 2021

Sponsor / Collaborator

Sunsho Pharmaceutical Co., Ltd.

100 Clinical Results associated with Towa Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Towa Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Towa Pharmaceutical Co., Ltd.

16 Aug 2024·Organic Process Research & Development

Development of a Safe and Environmentally Benign Manufacturing Process for Esomeprazole using an Iron Catalyst and Hydrogen Peroxide

Author: Ilies, Laurean ; Kouno, Takayoshi ; Izumi, Takuhiro ; Nishiguchi, Shigenobu ; Yamada, Tatsuya

The development of sustainable manufacturing processes for active pharmaceutical ingredients must address safety and environmental concerns.We successfully developed an environmentally benign process for the production of esomeprazole via asym. sulfoxidation using hydrogen peroxide as an oxidant in combination with an iron salt, a chiral Schiff base, and a carboxylate.This process uses 2.1 equiv of hydrogen peroxide as the oxidant, which poses safety issues for plant production owing to concerns surrounding the generation of oxygen and the hazards posed by the heat generated during the oxidation reaction.These issues can be mitigated by regulating the oxygen concentration with the nitrogen flow and maintaining the reaction temperature below the flash point of the solvent.Therefore, we evaluated the correlation between the addition rate of hydrogen peroxide, oxygen and heat flow profiles, and the heat accumulation properties.Based on this knowledge, we achieved the successful and safe manufacturing of esomeprazole at the kilo-lab and pilot production scales by optimizing the addition rate of hydrogen peroxide and nitrogen flow according to the reactor used.

01 May 2024·Pharmaceutical Research

Dissolution Profiles of Immediate Release Products of Various Drugs in Biorelevant Bicarbonate Buffer: Comparison with Compendial Phosphate Buffer

Article

Author: Higashino, Masaki ; Sugano, Kiyohiko ; Okamoto, Nanami ; Yamamoto, Hibiki

AbstractPurposeThe purpose of this study was to clarify the extent to which the dissolution profiles of immediate release (IR) products of various drugs differ between biorelevant bicarbonate buffer (BCB) and compendial phosphate buffer (PPB).MethodsThe dissolution profiles of the IR products of fifteen poorly soluble ionizable drugs were measured in BCB and PPB. BCB was set to be relevant to the small intestine (pH 6.8, 10 mM). The pH was maintained using the floating lid method. The Japanese pharmacopeia second fluid (JP2, 25 mM phosphate buffer, nominal pH 6.8) was used as compendial PPB. The compendial paddle apparatus was used for the dissolution tests (500 mL, 50 rpm, 37°C).ResultsIn 11/15 cases, a difference in dissolved% (< 0.8 or > 1.25-fold) was observed at a time point. In 4/15 cases, the ratio of the area under the dissolution curve was not equivalent (< 0.8 or > 1.25-fold). In the cases of free-form drugs, the dissolution rate tended to be slower in BCB than in JP2. In the case of salt-form drugs, a marked difference was observed for the cases that showed supersaturation. However, no trend was observed in the differences.ConclusionsMany IR products showed differences in the dissolution profiles between biorelevant BCB and compendial PPB. With the floating lid method, BCB is as simple and easy to use as PPB. Biorelevant BCB is recommended for dissolution testing.

13 Mar 2024·Chemical and Pharmaceutical Bulletin

Dissolution Profiles of Oral Disintegrating Tablet with Taste Masking Granule Polymer Coating in Biorelevant Bicarbonate Buffer

Article

Author: Sugano, Kiyohiko ; Higashino, Masaki

The current study aimed to explore the impact of buffer species on the dissolution behavior of orally disintegrating tablets (ODT) containing a basic polymer and its influence on bioequivalence (BE) prediction. Fexofenadine hydrochloride ODT formulations were used as the model formulations, Allegra^® as the reference formulation, and generic formulations A and B as the test formulations. Allegra^®, generic A, and generic B are ODT formulations that contain aminoalkyl methacrylate copolymers E (Eudragit^® E, EUD-E), a basic polymer commonly used to mask the bitter taste of drugs. Both generic A and generic B have been known to be bioequivalent to Allegra^®. The dissolution tests were conducted using a compendial paddle, with either bicarbonate (10 mM, pH 6.8) or phosphate buffer (25 mM, pH 6.8) as the dissolution media. A floating lid was employed to cover the surface of the bicarbonate buffer to prevent volatilization. Results indicated that in phosphate buffer, the dissolution profiles of Allegra and generic B significantly varied from that of generic A, whereas in the bicarbonate buffer, the dissolution profiles of Allegra, generic A, and generic B were comparable. These findings suggest that the use of bicarbonate buffer may offer a more precise prediction of human bioequivalence compared to phosphate buffer.

News (Medical) associated with Towa Pharmaceutical Co., Ltd.

01 Aug 2022

·www.prnewswire.com

Breckenridge Announces Approval of its ANDA for Cabazitaxel Intravenous Solution (generic for Jevtana Kit®)

BERLIN, Conn., Aug. 1, 2022 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Cabazitaxel Intravenous Powder (generic for Jevtana Kit®). This product was developed in collaboration with Natco Pharma Limited. Breckenridge received final approval for the 60mg/1.5mL (40mg/mL) strength. Breckenridge and Natco are unable to make further comment regarding the launch date for the product, as that is confidential and cannot be disclosed at this time. According to industry sales data, Jevtana Kit generated annual sales of $303 million during the twelve months ending May 2022. About Breckenridge: Breckenridge Pharmaceutical, Inc., a subsidiary of Towa Pharmaceutical (Osaka, Japan), partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients. With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we strive to impact the health of the patients we and our customers serve. About Natco: Natco Pharma Limited is a global generic pharmaceutical research, development, manufacturing and marketing company. The company was established in 1981 in India. Natco supplies pharmaceutical products to over 50 countries across the globe, including the United States. Natco focuses on the development and manufacturing of oncology and other specialty pharmaceuticals. For further information, please contact: Breckenridge Pharmaceutical, Inc. Robert Gasparino, Associate Vice President – Business Development Tel: 860-828-8140 E-mail: [email protected] *All brand names and trademarks are the property of their respective owners. SOURCE Breckenridge Pharmaceutical, Inc.

01 Oct 2021

·www.biospace.com

Breckenridge Announces Launch of its 10mg strength for Everolimus Tablets (generic for Afinitor®)

BERLIN, Conn., Oct. 1, 2021 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announces today that it has launched the 10mg strength of Everolimus Tablets (generic for Afinitor®). The U.S. Food and Drug Administration previously granted final approval of this Abbreviated New Drug Application. This product was developed in collaboration with Natco Pharma Limited. According to industry sales data, the 10mg strength of Afinitor generated annual sales of $392 million during the twelve months ending July 2021. Breckenridge previously launched its Everolimus tablets in 2.5mg, 5mg and 7.5mg strengths during the second quarter of 2021. About Breckenridge: Breckenridge Pharmaceutical, Inc., the U.S. subsidiary of Towa Pharmaceutical (Osaka, Japan), markets and distributes quality, cost-effective generic pharmaceuticals in the United States. Our products are developed in our affiliated research and development centers, as well as through strategic partnerships nationwide and around the world. With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we improve the health and lives of the patients we and our customers serve. About Natco: Natco Pharma Limited is a global generic pharmaceutical research, development, manufacturing and marketing company. The company was established in 1981 in India. Natco supplies pharmaceutical products to over 50 countries across the globe, including the United States. Natco focuses on the development and manufacturing of oncology and other specialty pharmaceuticals. For further information, please contact: Breckenridge Pharmaceutical, Inc. Robert Gasparino, Associate Vice President – Business Development Tel: 860-828-8140 E-mail: rgasparino@bpirx.com *All brand names and trademarks are the property of their respective owners.

29 Sep 2021

·www.biospace.com

Breckenridge Announces Approval of its ANDA for Teriflunomide Tablets (generic for Aubagio®)

BERLIN, Conn., Sept. 29, 2021 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Teriflunomide Tablets (generic for Aubagio®). This product was developed in collaboration with PharmaZell GmbH, Germany. Breckenridge received final approval for the 7mg and 14mg strengths. Sanofi Aventis LLC and Breckenridge have entered into a Settlement Agreement that permits Breckenridge to launch its generic teriflunomide product on March 12, 2023. According to industry sales data, Aubagio generated annual sales of approximately $1.9 billion during the twelve months ending July 2021. About Breckenridge: Breckenridge Pharmaceutical, Inc., the U.S. subsidiary of Towa Pharmaceutical (Osaka, Japan), markets and distributes quality, cost-effective generic pharmaceuticals in the United States. Our products are developed in our affiliated research and development centers, as well as through strategic partnerships nationwide and around the world. With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we improve the health and lives of the patients we and our customers serve. About Pharmazell: The PharmaZell Group supplies the pharmaceutical industry with Active Pharmaceutical Ingredients and natural source materials. The Group operates production facilities in Germany, Italy and India and offers a focused portfolio of small molecule APIs combined with Custom Development and Manufacturing Services for the pharmaceutical industry worldwide. For further information, please contact: Breckenridge Pharmaceutical, Inc. Robert Gasparino, Associate Vice President – Business Development Tel: 860-828-8140 E-mail: rgasparino@bpirx.com *All brand names and trademarks are the property of their respective owners.

Small molecular drug

100 Deals associated with Towa Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Towa Pharmaceutical Co., Ltd.

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Pipeline Snapshot as of 07 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

NDA/BLA

Approved

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Trihexyphenidyl Hydrochloride ( mAChRs )	Dyskinesias More	Approved
Dihydrocodeine PhoSphate/dl-Methylephedrine Hydrochloride/Chlorpheniramine Maleate	Cough More	Approved
Ferric Chloride/Manganese Chloride/Zinc Sulfate Hydrate/Cupric Sulfate/Potassium Iodide	Nutrition Disorders More	Approved
Kallidinogenase(Towa Pharmaceutical) ( KNG1 )	Menopausal syndrome More	Approved
Ascorbic Acid/Calcium Pantothenate	Avitaminosis More	Approved

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