Effects of Processing on a Sustained Release Formulation Prepared by Twin-Screw Dry Granulation

Ye, Xingyou; Kallakunta, Venkataraman; Kim, Dong Wuk; Patil, Hemlata; Tiwari, Roshan V.; Upadhye, Sampada B.; Vladyka, Ron S.; Repka, Michael A.

doi:10.1016/j.xphs.2019.04.004

Cited by 17 publications

(4 citation statements)

References 41 publications

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“…Dry granulation of samples was carried out following Ye et al [35] with certain modifications and granules were passed twice through the mesh size 30. To eliminate produced aggregates, the sample was passed through a mesh No.…”

Section: Evaluation Of Granulesmentioning

confidence: 99%

Evaluation of Modified Date Palm (Phoenix dactylifera L.) Mucilage as a Potential Pharmaceutical Excipient

Pasha

Bukhari

Mustafa

et al. 2022

Journal of Food Quality

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Investigation on natural sources from plants, animals, and microorganisms that produce gums and mucilages goes on increasing day by day to check their pharmaceutical applications. Different mucilages have been studied for their pharmaceutical effects but the use of date palm (Phoenix dactylifera L.) mucilage as a pharmaceutical excipient is still under the cover. The aim of this study was therefore to evaluate and compare the flow property and binding ability of crude, purified, modified (hydrolyzed and grafted), green synthesized nanoparticles (Zinc oxide (ZnO), cuperic oxide (CuO), silver (Ag), and gold (Au)) of date palm mucilage with hydroxy propyl methyl cellulose (HPMC) and commercially available paracetamol tablets. Previously purified mucilage (with 58.4% yield) was subjected to modification (i.e., acidic, basic, and enzymatic), grafting (polyacrylamide), and green synthesis of nanoparticles. Flow properties of powdered (granular) crude, purified, modified, and nanoparticles were studied and compared with flow properties of HPMC and paracetamol tablet granules. Tablets were made using granules of all types of date palm mucilage (discussed above), HPMC, and granules of paracetamol tablets to study and compare weight uniformity, hardness, friability, dissolution rate, and disintegration time. When 100 mg/kg of mucilage sample was given to mice no oral toxicity was found. The results obtained during this study were within the acceptable ranges given in pharmacopeias. The pseudoplastic flow behavior, hygroscopic nature, increased solubility, and swelling index across the increase in temperature, hardness of the tablets, friability, and drug release behavior were found better than HPMC and the binders used in commercially available paracetamol, hence making the date palm mucilage (crude, purified, and modified) an excellent excipient to be used in pharmaceutical dosage forms.

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Section: Evaluation Of Granulesmentioning

confidence: 99%

Evaluation of Modified Date Palm (Phoenix dactylifera L.) Mucilage as a Potential Pharmaceutical Excipient

Pasha

Bukhari

Mustafa

et al. 2022

Journal of Food Quality

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“…It can be designed to greatly reduce material residence time at elevated temperatures, enabling higher process temperatures without causing API or excipient degradation. To reduce the risk of thermal degradation, granulation can be achieved by frictional heating only, referred to as twin-screw dry granulation [ 34 ]. Shear between the screws’ mixing sections and overflight regions results in very efficient mixing so that lower binder levels are required to achieve the same tablet strength and hydrophilic matrix gelling for sustained release, reducing the overall tablet size [ 13 ].…”

Section: Melt Granulation Process Options Particularly Twin-screw Melt Granulation (Tsmg)mentioning

confidence: 99%

Twin-Screw Melt Granulation for Oral Solid Pharmaceutical Products

2021

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This article highlights the advantages of pharmaceutical continuous melt granulation by twin-screw extrusion. The different melt granulation process options and excipients are described and compared, and a case is made for expanded use of twin-screw melt granulation since it is a flexible and continuous process. Methods for binder selection are profiled with a focus on rheology and physical stability impacts. For twin-screw melt granulation, the mechanism of granulation and process impact on granule properties are described. Pharmaceutical applications of melt granulation ranging from immediate release of soluble and insoluble APIs, taste-masking, and sustained release formulation are reviewed, demonstrating the range of possibilities afforded by twin-screw melt granulation.

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“…Ye et al (2019) used twin screw dry granulation to improve the flow property of moisture sensitive materials [ 68 ]. They produced dry granule formulations using four different APIs processed with Klucel TM , Ethocel TM , and magnesium stearate for sustained release.…”

Section: Twin Screw Granulationmentioning

confidence: 99%

Advances in Twin-Screw Granulation Processing

et al. 2021

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Twin-screw granulation (TSG) is a pharmaceutical process that has gained increased interest from the pharmaceutical industry for its potential for the development of oral dosage forms. The technology has evolved rapidly due to the flexibility of the equipment design, the selection of the process variables and the wide range of processed materials. Most importantly, TSG offers the benefits of both batch and continuous manufacturing for pharmaceutical products, accompanied by excellent process control, high product quality which can be achieved through the implementation of Quality by Design (QbD) approaches and the integration of Process Analytical Tools (PAT). Here, we present basic concepts of the various twin-screw granulation techniques and present in detail their advantages and disadvantages. In addition, we discuss the detail of the instrumentation used for TSG and how the critical processing paraments (CPP) affect the critical quality attributes (CQA) of the produced granules. Finally, we present recent advances in TSG continuous manufacturing including the paradigms of modelling of continuous granulation process, QbD approaches coupled with PAT monitoring for granule optimization and process understanding.

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Effects of Processing on a Sustained Release Formulation Prepared by Twin-Screw Dry Granulation

Cited by 17 publications

References 41 publications

Evaluation of Modified Date Palm (Phoenix dactylifera L.) Mucilage as a Potential Pharmaceutical Excipient

Evaluation of Modified Date Palm (Phoenix dactylifera L.) Mucilage as a Potential Pharmaceutical Excipient

Twin-Screw Melt Granulation for Oral Solid Pharmaceutical Products

Advances in Twin-Screw Granulation Processing

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