Development and evaluation of an oral fast disintegrating anti-allergic film using hot-melt extrusion technology

Abstract

The main objective of this novel study was to develop chlorpheniramine maleate orally disintegrating films (ODF) using hot-melt extrusion technology and evaluate the characteristics of the formulation using in vitro and in vivo methods. Modified starch with glycerol was used as a polymer matrix for melt extrusion. Sweetening and saliva-simulating agents were incorporated to improve palatability and lower the disintegration time of film formulations. A standard screw configuration was applied, and the last zone of the barrel was opened to discharge water vapors, which helped to manufacture non-sticky, clear, and uniform films. The film formulations demonstrated rapid disintegration times (6–11 s) and more than 95% dissolution in 5 min. In addition, the films had characteristic mechanical properties that were helpful in handling and storage. An animal model was employed to determine the taste masking of melt-extruded films. The lead film formulation was subjected to a human panel for evaluation of extent of taste masking and disintegration.

Characterization of orodispersible tablets and orodispersible films

“…Pregledom literature je uočeno da se za ispitivanje brzine rastvaranja lekovitih supstanci iz ODF obično koriste ili aparatura sa lopaticom pri brzini obrtanja 50-100 rpm (10,54,55) ili aparatura sa korpicom (56). Osnovni problem se ogleda u tome što su ODF skloni flotiranju.…”

Hot Melt Extrusion: Highlighting Physicochemical Factors to Be Investigated While Designing and Optimizing a Hot Melt Extrusion Process

“…First developed and used in the plastics industry, hot melt extrusion (HME) has been applied in the pharmaceutical industry as a simple, reproducible, and fast method for producing many solid dosage forms of drugs [ 1 , 2 ] for different delivery routes, such as the oral route (granules, pellets, and tablets) [ 3 , 4 , 5 , 6 ], the transdermal and transmucosal route [ 7 ], and the subcutaneous route (implants) [ 8 , 9 , 10 ], some of the most widely developed applications are for: Taste masking [ 11 , 12 ] Improved dissolution of poorly soluble drugs [ 13 , 14 , 15 , 16 ] Sustained release formulations [ 17 , 18 ] and Preparation of nanosystems [ 19 , 20 , 21 , 22 ]. …”

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

“…Currently, solvent casting, printing, compression and hot‐melt extrusion (HME) are the various techniques used for preparation of films. 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 .…”

“…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. [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.…”