Delving into the Latest Updates on Alogliptin Benzoate/Metformin Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

ALOGLIPTIN AND METFORMIN HYDROCHLORIDE, ALOGLIPTIN/METFORMIN HYDROCHLORIDE, Alogliptin/metformin

+ [10]

Target

DPP-4 x PRKAB1

Mechanism

DPP-4 inhibitors(Dipeptidyl peptidase IV inhibitors), PRKAB1 activators(Protein kinase AMP-activated non-catalytic subunit beta 1 activators)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication-

Originator Organization

Takeda Pharmaceutical Co., Ltd.

Active Organization

Teijin Pharma Ltd.

Takeda Pharmaceutical Co., Ltd.Takeda Pharma A/S

+ [1]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (25 Jan 2013),

Diabetes Mellitus, Type 2

Regulation-

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Structure

Molecular FormulaC4H12ClN5

InChIKeyOETHQSJEHLVLGH-UHFFFAOYSA-N

CAS Registry1115-70-4

View All Structures (2)

Different simple spectrophotometric methods were developed for simultaneous determination of alogliptin and metformin manipulating their ratio spectra with successful application on recently approved combination, Kazano® tablets. Spiking was implemented to detect alogliptin in spite of its low contribution in the pharmaceutical formulation as low quantity in comparison to metformin. Linearity was acceptable over the concentration range of 2.5-25.0μg/mL and 2.5-15.0μg/mL for alogliptin and metformin, respectively using derivative ratio, ratio subtraction coupled with extended ratio subtraction and spectrum subtraction coupled with constant multiplication. The optimized methods were compared using one-way analysis of variance (ANOVA) and proved to be accurate for assay of the investigated drugs in their pharmaceutical dosage form.

01 Feb 2017·Die PharmazieQ4 · MEDICINE

Comparative study between UHPLC-UV and UPLC-MS/MS methods for determination of alogliptin and metformin in their pharmaceutical combination.

Q4 · MEDICINE

Article

Author: Mowaka, S. ; Ayoub, B. M.

A new UPLC-MS/MS method (method A), for simultaneous determination of alogliptin (ALN) and metformin (MET) in their recently approved pharmaceutical combination Kazano® tablets, was developed and compared to a new UHPLC-UV method (method B). Concerning method A, separation was achieved on Hypersil gold 50 mm × 2.1 mm (1.9 μm) column, using acetonitrile and 0.2 % formic acid aqueous solution as the mobile phase with a gradient elution. Electrospray ionization (ESI) source was operated in positive ion mode. Selected reaction monitoring (SRM) mode on a triple quadropole mass spectrometer was used to quantify the drugs utilizing the transitions of 340.33 → 116.32 (m/z) and 130.12 → 71.32 (m/z) for ALN and MET, respectively. Concerning chromatographic separation using UV detection in method B, it was achieved on a Symmetry® C18 column 100 mm × 2.1 mm (2.2 μm) applying an isocratic elution based on methanol - water (10:90, v/v) at pH 3 as a mobile phase. The photodiode array detector was operated at 210 nm. Method A showed good linearity over the concentration ranges of 5-400 ng mL-1 and 25-2000 ng mL-1 for ALN and MET, respectively, while method B showed satisfactory results using ranges of 0.25-8 μg mL-1 and 5-50 μg mL-1 for ALN and MET, respectively. The optimized validated methods are suitable for QC labs but the UPLC-MS/MS method offered the advantage of shorter analytical times and higher sensitivity and selectivity.

01 Dec 2016·Die PharmazieQ4 · MEDICINE

A guide for using experimental design in chromatographic method development: applied to the analysis of selected anti-diabetic pharmaceutical combinations.

Q4 · MEDICINE

Article

Author: Ayoub, B. M. ; Abdel-Aziz, O.

A guide experimental design in chromatographic method development was described and applied successfully to the analysis of different recently approved anti-diabetic pharmaceutical combinations. Enhancement of UHPLC analysis of alogliptin benzoate either with pioglitazone hydrochloride or with metformin hydrochloride was achieved. The optimal chromatographic conditions were not attained by trial and error that requires a large number of experiments. Alternatively, a computer program was used as a systematic optimization strategy for the design of the experiment which accurately predicts the combined effect of different factors simultaneously. Resolution between peaks was studied by the proposed fractional factorial design approach performed by the Minitab® Program using screening and optimization steps. Application of the central composite design was implemented. A Pareto chart was used to exclude the insignificant variables. Linearity ranges were found to be 0.5-40 μg ml-1, 1-20 μg ml-1 and 1-32 μg ml-1 for alogliptin benzoate, pioglitazone hydrochloride and metformin hydrochloride, respectively. The proposed method is applicable for the analysis of six pharmaceutical dosage forms namely, Nesina®, Actos®, Glucophage®, Oseni®, Kazano® and Actoplus MET® tablets.

100 Deals associated with Alogliptin Benzoate/Metformin Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10BD13	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	US	Takeda Pharmaceuticals U.S.A., Inc.	25 Jan 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 1	MY	Takeda Pharmaceutical Co., Ltd.	27 Aug 2013
Diabetes Mellitus, Type 2	Phase 1	KR	Takeda Pharmaceutical Co., Ltd.	27 Aug 2013
Diabetes Mellitus, Type 2	Phase 1	CN	Takeda Pharmaceutical Co., Ltd.	27 Aug 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02276274 (CTgov)	Phase 3	-	12	SYR-322-MET (SYR-322-MET Fasted)	fcscvkpoxx(mcqfnmkzex) = qtwlnmnmrb lyqdnvbtob (xtiojndvqu, bnzedvcxhj - jkujvmxjum) View more	-	29 Jun 2015
				SYR-322-MET (SYR-322-MET Fed)	fcscvkpoxx(mcqfnmkzex) = clqpvnpwvx lyqdnvbtob (xtiojndvqu, oxcljtznks - xuhjgzsobj) View more