Study of excipients quantities influencein the composition of the powder in sachet packages

Тригубчак, О. В.; Gureyeva, Svetlana; Yuryeva, Olga

doi:10.15587/2519-4852.2018.122007

Cited by 2 publications

(1 citation statement)

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“…Significant influence is demonstrated by the factors x 7 and x 4 . The lowest pH values were observed with the addition of 0.0820 g of calcium phosphate, 0.1210 g of sodium citrate, 0.2085 g of lemon-lime flavour, and 0.0014 g of titanium dioxide [37].…”

Section: Medical Researchmentioning

confidence: 91%

Development Of Formulation and Technology of Combined Generic Powder for Oral Solution in Sachets Based on the Quality by Design Approach

Panysheva¹

2022

GJMR

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Using quality by design approaches (dispersion analysis and random balance method), the formulation and technology of powder for oral solution in sachets were developed. It includes paracetamol, ascorbic acid, phenylephrine hydrochloride, and pheniramine maleate. The influence of 27 excipients from 5 functional groups on 11 quality attributes was established by the dispersion analysis. The preferred excipients were selected using the utility function. The quantities of preferable excipients (7 quantitative factors at three levels) were researched by the random balance method. Their influence on 11 pharmaco-technological parameters of the powder and the physical properties of the solution studied. The optimal composition of the powder for the oral solution established. 9 sequences of introducing components were analyzed by dispersion analysis. The optimal technology of the powder for oral solution in sachets byroll compaction is established.

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Section: Medical Researchmentioning

confidence: 91%

Development Of Formulation and Technology of Combined Generic Powder for Oral Solution in Sachets Based on the Quality by Design Approach

Panysheva¹

2022

GJMR

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Substantiation of technology for obtaining capsules of a multi-component drug with neurotropic action

Almakaiev

Sidenko²

2021

SR: PS

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The aim of the work. Theoretical and experimental substantiation of a rational technology for obtaining a preparation in the form of capsules based on uridine-5-monophosphate of disodium salt, cytidine-5-monophosphate of disodium salt, vitamin B6, thioctic acid and magnesium lactate dihydrate, determination of process parameters that can affect critical quality characteristics active pharmaceutical ingredients in the product and establishing acceptance criteria for each critical process parameter to be used in batch production and process control. Materials and methods. Objects of the research: masses for encapsulation, granulates and the finished product - capsules with the conventional name “Neuronucleos”. To obtain capsules, active pharmaceutical ingredients (API) were used: uridine-5-monophosphate disodium salt and cytidine-5-monophosphate disodium salt (Shanghai Oripharm Co. Ltd., China), thioctic acid (Shanghai Modern Pharmaceutical Co., Ltd..”, China), pyridoxine hydrochloride (“DSM Nutritional Products GmbH”, Germany), magnesium lactate (“Moes Cantabra S.L.”, Spain). The quality indicators were studied: description, average mass of content and uniformity of mass, uniformity of dosage units, dissolution, accompanying impurities, quantitative content of API. Methods of liquid chromatography and complexometric titration were used. Results. It has been established that the use of the direct mixing method does not allow obtaining a mass for encapsulation corresponding to the indicator "Bulk density". The use of the wet granulation method in a fluidized bed has been substantiated. It has been shown that it is difficult to perform granulation in a fluidized bed of an API mixture containing thioctic acid. It has been established that it is rational to obtain a mass for encapsulation in two stages: obtaining a granulate from magnesium lactate dihydrate and pyridoxine hydrochloride with a moisturizer solution (sorbitol + uridine-5-monophosphate disodium salt + cytidine-5-monophosphate disodium salt) and then obtaining a mass for encapsulation from granulate, thioctic acid, anhydrous colloidal silicon dioxide and magnesium stearate by the direct mixing method. Conclusions. On the basis of the performed technological research and analysis of the quality of the obtained capsules, a method for obtaining a capsule mass using the method of wet granulation in a fluidized bed was chosen. The granulation mode was substantiated and the optimal parameters for obtaining a high-quality product were selected, the acceptance criteria for each critical parameter of the technological process were established

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Study of excipients quantities influencein the composition of the powder in sachet packages

Cited by 2 publications

References 1 publication

Development Of Formulation and Technology of Combined Generic Powder for Oral Solution in Sachets Based on the Quality by Design Approach

Development Of Formulation and Technology of Combined Generic Powder for Oral Solution in Sachets Based on the Quality by Design Approach

Substantiation of technology for obtaining capsules of a multi-component drug with neurotropic action

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