Development and optimization of ketoconazole oral strips by means of continuous hot-melt extrusion processing.
نویسندگان
چکیده
OBJECTIVES The aim of this study was to develop mucoadhesive oral strips using hot-melt extrusion as a continuous manufacturing process. METHODS Powder blends of ketoconazole, a water-insoluble drug - either hydroxypropyl methylcellulose (HPMC) or soluplus (SOL), sorbitol (SRB) and magnesium aluminometasilicate (MAS) were extruded to manufacture thin strips with 0.5-mm thickness. The presence of the inorganic metasilicate facilitated smooth processing of the extruded strips as it worked as an absorbent directly impacting on the extensive mixing of the drug/excipients inside the extruder barrel. KEY FINDINGS The use of MAS also favoured the rapid hydration, swelling and eventual disintegration of the strips. Differential scanning calorimetry and transmission X-ray diffraction analysis revealed the existence of the amorphous drug within the extruded strips. Scanning electron microscopy and energy dispersive X-ray undertaken on the formulations showed a homogeneous drug distribution within the extruded strips. CONCLUSION The strips produced via continuous hot-melt extrusion processing showed significantly faster release of ketoconazole compared to the bulk drug substance.
منابع مشابه
Hot-Melt Extrusion Technique: A Review
Hot-melt extrusion is one of the most widely applied processing technologies in the plastic, rubber and food industry. Today this technology has found its place in the array of pharmaceutical manufacturing operations. Melt extrusion process are currently applied in the pharmaceutical field for the manufacture of a variety of dosage forms and formulations such as granules, pellets, tablets, supp...
متن کاملHot-Melt Extrusion Technique: A Review
Hot-melt extrusion is one of the most widely applied processing technologies in the plastic, rubber and food industry. Today this technology has found its place in the array of pharmaceutical manufacturing operations. Melt extrusion process are currently applied in the pharmaceutical field for the manufacture of a variety of dosage forms and formulations such as granules, pellets, tablets, supp...
متن کاملHot melt extrusion technology, approach of solubility enhancement: A brief review
During the developmental process, there is an estimated 40 to 70% incidence of delay or failure for new drug entities due to poor biopharmaceutical properties such as poor solubility, poor permeability and poor chemical stability. Hot melt extrusion (HME) technology may provide the answer. HME, a solid-dispersion technology, has gained popularity in the pharmaceutical industry as a means of imp...
متن کاملNumerical study and genetic algorithm optimization of hot extrusion process to produce rectangular waveguides
Rectangular waveguide is one of the earliest types of transmission lines. Rectangular waveguide can be produced by hot extrusion process. In this paper, the hot extrusion process of CuZn5 rectangular waveguide was investigated by Finite Element Method (FEM). In addition, Genetic Algorithm (GA) was used to optimize the die geometry and process conditions to achieve the lowest magnitude of extrus...
متن کاملHot Melt Extrusion Technique
Various approaches have been adopted to address this including preparation of solid dispersions and solid solutions. Hot-melt extrusion is an efficient technology for producing solid molecular dispersions with considerable advantages over solvent-based processes such as spray drying and co-precipitation. Hot-melt extrusion has been demonstrated to provide sustained, modified, and targeted drug ...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- The Journal of pharmacy and pharmacology
دوره 68 7 شماره
صفحات -
تاریخ انتشار 2016