|
X. Parissaux(1), A. Joshi(2), A. Francois(1) and P. Lefevre (1)
(1) Roquette Frères, Lestrem, France
(2) Roquette America Inc., Keokuk, IA 52632
Introduction
Beginning with its roots in confectionary and breath-freshening applications, Orodispersible Films (ODFs) have advanced significantly as a novel drug-delivery system to treat sore throat, pain, gas/bloating, cough/cold etc. ODFs offer advantages of fast and precise systemic dosing in a safe and effective manner with added convenience and portability.
Most marketed ODFs have complex, patent-protected formulations, which differ significantly in their composition and behavior. In the absence of official tests to evaluate thin-films, this study was conducted to evaluate the specific properties related to the industrial manufacturing of marketed films and to compare those to films obtained using a novel polymer, LYCOAT®NG73.
Although all the marketed ODFs tested worked well within industrial production constraints, the data presented will show that the commercial film formulations exhibited very different behavior in film properties.
LYCOAT®NG73 is a novel, granular, hydroxypropyl starch polymer that has been designed especially for ODFs. It can be used as the sole film-forming polymer to formulate ODFs with excellent functionality without the need for additional filmforming agents.
LYCOAT®NG73 ODFs are comparable to the currently marketed ODFs and exhibit good functional and stability properties. The major advantages with LYCOAT®, are the simplicity of the formulation (needs very few excipients) and freedom from patent restriction in the development of thin-film drug delivery systems.
Summary and conclusions
ODFs are attractive dosage forms due to convenience and portability for patients.
Potent APIs are homogenously dispersed in a solid dispersion matrix, which improves the speed of dissolution. ODFs thus provide all the homogeneity advantages of a liquid formulation with the convenience and stability of a solid dosage form.
Further to the analysis of marketed ODFs, there is no single profile of properties that suits the constraints of an industrial equipment. Wide variation in the composition as well as thermal / mechanical properties of commercial ODFs remains compatible with industrial manufacturing constraints
LYCOAT®
-
Is a novel, granular hydroxypropyl starch specially designed for ODFs
-
Gives a homogenous solution as viscosity develops progressively by cooking thus preventing formation of lumps or agglomerates
-
Allows incorporation of thermolabile APIs after cooling
-
Films are easy to manufacture using commercial equipment even without the use of any organic solvents
-
Provides significant advantages:
- Simplistic ODF formulations using LYCOAT® as the sole polymer
- Formulations are free of patent restrictions, common with current ODFs
|
