Development of an Ointment Formulation Using Hot-Melt Extrusion Technology

Abstract

Abstract. Ointments are generally prepared either by fusion or by levigation methods. The current study proposes the use of hot-melt extrusion (HME) processing for the preparation of a polyethylene glycol base ointment. Lidocaine was used as a model drug. A modified screw design was used in this process, and parameters such as feeding rate, barrel temperature, and screw speed were optimized to obtain a uniform product. The product characteristics were compared with an ointment of similar composition prepared by conventional fusion method. The rheological properties, drug release profile, and texture characteristics of the hot-melt extruded product were similar to the conventionally prepared product. This study demonstrates a novel application of the hotmelt extrusion process in the manufacturing of topical semi-solids.

Novel Gastroretentive Floating Pulsatile Drug Delivery System Produced via Hot-Melt Extrusion and Fused Deposition Modeling 3D Printing

“…Over the last three decades, its use in drug delivery and research has tremendously increased owing to the advantages associated with this technology, such as high efficiency, solvent-free, innovative applications, and continuous manufacturing [17]. Although HME is most widely used in the preparation of amorphous solid dispersions, it is also used in the development of many innovative applications, such as taste masking, abuse-deterrent formulations, chronotherapeutic systems, topical formulations, semi-solid dosage forms, and co-amorphous systems [18][19][20][21][22]. Recently, the interest of researchers has shifted to additive manufacturing of pharmaceutical dosage forms where HME is combined with three-dimensional (3D) printing.…”

Carboxyvinyl Polymer and Guar-Borate Gelling System Containing Natamycin Loaded PEGylated Nanolipid Carriers Exhibit Improved Ocular Pharmacokinetic Parameters

“…Texture analyses for NTM-PNLC-GEL was performed using Texture Analyzer model TA.XT2i (Texture Technologies Corp.) along with a 1 † diameter (TA-3), cylindrical, acrylic probe, and a soft matter kit (TA-275). 23 NTM-PNLC-GELs were placed in the soft matter fixture and placed below the TA-3 probe, and the texture analyses were performed according to the parameters specified in Table 3.…”

Effects of formulation composition on the characteristics of mucoadhesive films prepared by hot-melt extrusion technology

“…Although solvent casting is the most commonly used method for film preparation, it has many disadvantages, like multistep process, batch to batch variations, air entrapment and removal of solvent from the product is time‐consuming and tedious . On the contrary, HME is solvent free, adaptable to continuous manufacturing, and an economical process . HME involves heating the mixture of polymer blend and drug in a barrel and forcing it through a die to obtain granules or films .…”

“…[17] On the contrary, HME is solvent free, adaptable to continuous manufacturing, and an economical process. [18][19][20] HME involves heating the mixture of polymer blend and drug in a barrel and forcing it through a die to obtain granules or films. [21] The heat and the shear via the mixing elements ensure the mixing of all the components uniformly.…”