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Vonoprazan (Preformulation Study)

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128 views2 pages

Vonoprazan (Preformulation Study)

Uploaded by

Orbit Pharmaceuticals Ltd
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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PRODUCT DEVELOPMENT DEPARTMENT Navana Pharmaceuticals Ltd.

PREFORMULATION STUDY Rupshi, Narayanganj, Bangladesh

Product Name Vonoprazan Fumarate Tablet


01
Generic Name Vonoprazan fumarate Equivalent to Vonoprazan
02

03 Dosage Form Tablet

04 Strength 10 mg and 20 mg

05 Category First in class potassium competitive acid blocker


Available Market Innovator: Takecab (Takeda Pharmaceutical Company Limited)
06 Sample Local:

Packaging Mode Innovator: Plastic Bottle, Alu -PVC/PVDC


07 of the Market Local:
Sample
Details description White to off white ,crystalline powder .
08
of API
8.1 Chemical C21H20 FN3O6S
Formula
8.2 Chemical
Structure

8.3 Molecular 461.46


Weight
8.4 Functional Amine, Carboxylic
Group
8.5 CAS Number 1260141-27-2

8.6 Hygroscopicit Low Hygroscopicity


y
8.7 Light Less Light sensitive
Sensitivity
8.8 Solubility Soluble in dimethyl sulfoxide , Slightly soluble in methanol, water .very slightly soluble in
ethanol
9 Metabolism Hepatic, by cytochrome P450 (3A4, 2B6, 2C19, 2D6)

10 Half Life 7.7 hours

11 Excretion Renal

12 Drug Interaction Atazanivir, Rilpivirine, Clarithromycin, Digoxin, Methyldigoxin,Itraconazole,Gefitinib,Nilotinib,


erlotinib, Nelfinavir

Page 1 of 2
PRODUCT DEVELOPMENT DEPARTMENT Navana Pharmaceuticals Ltd.
PREFORMULATION STUDY Rupshi, Narayanganj, Bangladesh

14 Certificate of Present
Analysis of API
15 Method of INN
Analysis (For INN
16 Material)
Chemical Active No information Available
Incompatibility Incompatibility:

Active-
Excipients
Incompatibility: No information Available

Formulation in Vonaprazan Fumarate , D-Mannitol, Microcrystalline Cellulose, Cros carmellose Sodium,


17 International Hydroxypropylcellose, Fumaric Acid, Magnesium Stearate,Hypromellose, Macrogol 6000,
Market titanium oxide, yellow ferric oxide (only in 10 mg tablet), red ferric oxide ( only in 20 mg tablet)

18 Proposed
Formulation Vonaprazan Fumarate ,Mannitol, Microcrystalline Cellulose, Cros carmellose Sodium,
Pregelatinized Strach

19 Others N/A

Prepared By:………………….Checked By:………………… Approved By:………………..

Page 2 of 2

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