Influence of Tartaric Acid on the Bioadhesion and Mechanical Properties of Hot-Melt Extruded Hydroxypropyl Cellulose Films for the Human Nail

• Published in: Drug development and industrial pharmacy Vol. 32; no. 9; pp. 1059 - 1066
• Main Authors: Mididoddi, P. K., Prodduturi, S., Repka, M. A.
• Format: Journal Article
• Language: English
• Published: Colchester Informa UK Ltd 01-10-2006; Taylor & Francis
• Subjects: Antifungal Agents - chemistry; Bioadhesion; Biological and medical sciences; Biomechanical Phenomena; Cellulose - analogs & derivatives; Cellulose - chemistry; General pharmacology; Hot-melt extrusion; Humans; In Vitro Techniques; Ketoconazole - chemistry; Materials Testing; Mechanical properties; Medical sciences; Molecular Weight; Nail; Nails; Pharmaceutical technology. Pharmaceutical industry; Pharmacology. Drug treatments; Tartaric acid; Tartrates - chemistry; Technology, Pharmaceutical; Thermogravimetric analysis (TGA); Thermogravimetry; Tissue Adhesives - chemistry; Water - chemistry; Human; Bioadhesion; Hot melt; Pharmaceutical technology; Film; Thermogravimetry; Mechanical properties; Tartaric acid; Hot-melt extrusion; Nail; Thermogravimetric analysis (TGA); Acids; Cellulose(hydroxypropyl); Extrusion
• ISSN: 0363-9045; 1520-5762
• DOI: 10.1080/03639040600683410

ABSTRACT
The objective of this study was to investigate the influence of tartaric acid (TTA) on the bioadhesive, moisture sorption, and mechanical properties of hot-melt-extruded (HME) hydroxypropyl cellulose (HPC) films containing polymer additives. Two Klucel® EF and LF batches (HPC, MW: 80000 and 95000, respectively) containing the model antifungal drug ketoconazole (one batch of each MW with and without TTA 4%) were prepared into films by HME using a Killion extruder (Model KLB-100). The bioadhesive properties of the HPC films, with and without TTA, were investigated ex vivo on the human nails. The parameters measured were work of adhesion and peak adhesion force (PAF). A statistically significant increase in both the area under the curve (AUC) and PAF was seen for the HME films containing TTA than those without TTA. Moisture content of hot-melt extruded HPC films was determined using thermogravimetric analysis (TGA). TGA data collected at the two-week interval (25°C/60% RH), measured higher moisture content for the TTA-containing films than those without TTA. Tensile strength and percent elongation were determined utilizing a TA.XT2i Texture Analyzer® equipped with a 50-kg load cell, TA-96 grips, and Texture Expert™ software. TTA functioned as an effective plasticizer, increasing percent elongation and decreasing tensile strength of the HPC films. TTA could potentially be a candidate for transnail applications in film devices prepared by hot-melt extrusion technology.