Continuous Manufacturing of Oil in Water (O/W) Emulgel by Extrusion Process

Echanur, V. Anusha; Matadh, Anusha V.; Pragathi, S. G.; Sarasija, S.; Yeoh, Thean; Badruddoza, Abu Zayed Md; Shah, Jaymin; Kulkarni, Vijay; Ajjarapu, Srinivas; Reena, N. M.; Shivakumar, H.N.; Murthy, S. Narasimha

doi:10.1208/s12249-023-02530-x

Cited by 6 publications

(10 citation statements)

References 17 publications

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“…The prepared emulgels were characterized for pH, water activity, globule size distribution, and in vitro release rate. It was found that higher screw speed resulted in smaller globules and higher drug release from emulgels compared to emulgels prepared at lower screw speed 29 .…”

Section: Continuous Manufacturingmentioning

confidence: 96%

Novel Applications of Hot Melt Extrusion Technology

Samanthula

Kemisetti

Mandhadi

et al. 2023

J. Drug Delivery Ther.

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Hot melt extrusion (HME) technology was introduced to pharmaceuticals in the 1970s for manufacturing and product development. Since then, there were several developments in HME technology to utilize it effectively for the manufacturing of pharmaceuticals. Though the primary purpose of HME technology remains to be solubility enhancement through the preparation of amorphous solid dispersions, it also has various other applications like dry granulation, abuse-deterrent formulation, continuous manufacturing, film preparation, implants, sustained release formulations, etc. The purpose of this review article is to consolidate the information related to applications of HME technology in the pharmaceutical industry. Keywords: Hot melt extrusion, poorly soluble drugs, continuous manufacturing, solid orals, and applications.

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Section: Continuous Manufacturingmentioning

confidence: 96%

Novel Applications of Hot Melt Extrusion Technology

Samanthula

Kemisetti

Mandhadi

et al. 2023

J. Drug Delivery Ther.

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“…40 HME is known to impart just enough temperature and shear to consistently produce stable topical semisolid formulations like ointments, 22 gels, 41 creams, 42 and emulgels. 43 The processing conditions of HME can be easily customized to obtain the desired products. HME is known to perform melting and mixing in a single step and is therefore considered to be more effective compared to conventional preparation methods that are found to be more time-consuming.…”

Section: Extrusion Process For CM Of Topical Productsmentioning

confidence: 99%

“…Recently, we have explored the CM of an O/W emulgel of lidocaine by HME was investigated. 43 The effect of barrel temperature (25/60 °C) and screw speed (100, 300, and 600 rpm) on the globule size and in vitro drug release was elucidated. The studies indicated that the globules size did not differ significantly with change in the barrel temperature.…”

Section: Processing Parametersmentioning

confidence: 99%

“…As the rate of shear increased, it was found to decrease the consistency of the shear thinning system, thereby facilitating the spreadability of the creams as well. Recently, we have explored the CM of an O/W emulgel of lidocaine by HME was investigated . The effect of barrel temperature (25/60 °C) and screw speed (100, 300, and 600 rpm) on the globule size and in vitro drug release was elucidated.…”

Section: Extrusion Process For CM Of Topical Productsmentioning

confidence: 99%

“…50 Medium-chain triglyceride (MCT) 70 was used as an oil phase, while Sepineo P600 used as a emulsifier in production of O/W emulgel by HME. 43 Sepinneo P60 is an acrylamide sodium acryloyl dimethyl taurate copolymer, isohexadecane. The mixture of Sepineo P 600 and MCT 70 were kept under constant stirring before they are fed into the HME to produce a consistent and stable emulgel.…”

Section: Materials Attributesmentioning

confidence: 99%

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Can Continuous Manufacturing of Topical Semisolids by Hot Melt Extrusion Soon Be a Reality?

Matadh,

Echanur,

Suresh

et al. 2023

Mol. Pharmaceutics

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For more than five decades, pharmaceutical manufacturers have been relying heavily on batch manufacturing that is a sequential, multistep, laborious, and time-consuming process. However, late advances in manufacturing technologies have prompted manufacturers to consider continuous manufacturing (CM) is a feasible manufacturing process that encompasses fewer steps and is less tedious and quick. Global regulatory agencies are taking a proactive role to facilitate pharmaceutical industries to adopt CM that assures product quality by employing robust manufacturing technologies encountering fewer interruptions, thereby substantially reducing product failures and recalls. However, adopting innovative CM is known to pose technical and regulatory challenges. Hot melt extrusion (HME) is one such state-of-the-art enabling technology that facilitates CM of diverse pharmaceutical dosage forms, including topical semisolids. Efforts have been made to continuously manufacture semisolids by HME integrating the principles of Quality by Design (QbD) and Quality Risk Management (QRM) and deploying Process Analytical Technologies (PAT) tools. Attempts have been made to systematically elucidate the effect of critical material attributes (CMA) and critical process parameters (CPP) on product critical quality attributes (CQA) and Quality Target Product Profiles (QTPP) deploying PAT tools. The article critically reviews the feasibility of one of the enabling technologies such as HME in CM of topical semisolids. The review highlights the benefits of the CM process and challenges ahead to implement the technology to topical semisolids. Once the CM of semisolids adopting melt extrusion integrated with PAT tools becomes a reality, the process can be extended to manufacture sterile semisolids that usually involve more critical processing steps.

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