Development of a HPLC-DAD stability-indicating method and compatibility study of azathioprine and folic acid as a prerequisite for a monolayer fixed-dose combination

2021 ◽  
Vol 13 (11) ◽  
pp. 1422-1431
Author(s):  
Edvin Brusač ◽  
Mario-Livio Jeličić ◽  
Daniela Amidžić Klarić ◽  
Biljana Nigović ◽  
Sabina Keser ◽  
...  
Keyword(s):  
Folic Acid ◽  
Process Control ◽  
Quality Assessment ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Compatibility Study ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Dose Combination ◽  
Active Substances

Physicochemical compatibility of active substances confirmed using multiple techniques and a stability-indicating method developed for quality assessment and in-process control.

scholarly journals Fixed-Dose Combination of NSAIDs and Spasmolytic Agents in the Treatment of Different Types of Pain—A Practical Review

2021 ◽  
Vol 10 (14) ◽  
pp. 3118
Author(s):  
Magdalena Janczura ◽  
Małgorzata Kobus-Moryson ◽  
Szymon Sip ◽  
Marcin Żarowski ◽  
Agnieszka Wareńczak ◽  
...  
Keyword(s):  
De Novo ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Common Disease ◽  
Therapeutic Principles ◽  
Spasmolytic Agents ◽  
Dose Combination ◽  
Disease Entities ◽  
Active Substances ◽  
Significant Therapeutic Effect

This review presents the most common disease entities in which combinations of NSAIDs and spasmolytic drugs are used to reduce pain. The benefits of fixed-dose combination products (FDCs) are that they improve the response in people with insufficient monotherapy. Using the synergy or additive effect of drugs, it is possible to obtain a significant therapeutic effect and faster action with the use of smaller doses of individual drugs. In addition, one active ingredient may counteract adverse reactions from the other. Another essential aspect of the use of FDCs is the improvement of medical adherence due to the reduction in the pill burden on patients. It is also possible to develop a fixed-dosed combination product de novo to address a new therapeutic claim and be protected by patents so that the manufacturer can obtain exclusive rights to sell a particular FDC or a formulation thereof. The proposed fixed-dose combinations should always be based on valid therapeutic principles and consider the combined safety profile of all active substances included in the medicinal product. This review aims to identify which combinations of NSAIDs and spasmolytics have been developed and tested and which combinations are still under development.

scholarly journals A rapid stability-indicating, fused-core HPLC method for simultaneous determination of β-artemether and lumefantrine in anti-malarial fixed dose combination products

2013 ◽  
Vol 12 (1) ◽  
pp. 145 ◽  
Author(s):  
Sultan Suleman ◽  
Kirsten Vandercruyssen ◽  
Evelien Wynendaele ◽  
Matthias D’Hondt ◽  
Nathalie Bracke ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
Hplc Method ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Stability Indicating ◽  
Dose Combination

scholarly journals Innovative stability-indicating LC-Corona CAD method for simultaneous determination of assay in Artesunate and Mefloquine hydrochloride fixed-dose combination product

2021 ◽  
pp. 103657
Author(s):  
Wilson Camargo ◽  
Diogo Dibo ◽  
Monique Silva dos Santos ◽  
Ivone de Jesus do Nascimento Lopes ◽  
Flávia Furtado de Mendonça de Sousa ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Combination Product ◽  
Stability Indicating ◽  
Dose Combination ◽  
Corona Cad

scholarly journals COMPATIBILITY STUDY BETWEEN PRAVASTATIN AND EZETIMIBE, AND PHARMACEUTICAL EXCIPIENTS USED IN FIXED-DOSE COMBINATION TABLET

2021 ◽  
pp. 84-89
Author(s):  
KANG MIN KIM
Keyword(s):  
High Performance ◽  
Physical Stability ◽  
Drug Formulation ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Compatibility Study ◽  
Scanning Calorimetry ◽  
Combination Tablet ◽  
Tg Analysis ◽  
Dose Combination

Objective: The purpose of this study was to qualitatively predict drug-excipient binding interactions for stable drug formulation of a pravastatin and ezetimibe fixed-dose combination (FDC) tablet. Methods: Drug impurity-excipient interactions under accelerated conditions (40°C/75% relative humidity) for 4 weeks were confirmed by high-performance liquid chromatography, X-ray diffraction (XRD), differential scanning calorimetry (DSC) and thermogravimetric (TG) analysis. Results: Pravastatin impurity was affected by four excipients under accelerated conditions for 4 weeks. Ezetimibe was affected by two excipients. Any other results were within the acceptance criteria. XRD analysis for physical stability revealed characteristic peaks of pravastatin and ezetimibe at a diffraction angle of 2θ (pravastatin: 4.1–24.4°, and ezetimibe: 13.62–29.59°) without a change in the crystalline form after 4 weeks. DSC and TG analysis showed evidence of stability in Alu-Alu foil. Conclusion: Thus, the tested excipients were confirmed to be compatible with pravastatin and ezetimibe and can be used in FDC bi-layer tablets.

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