Medicine and Health Sciences Commons^™

Quality By Design Based Optimization Of Anti-Inflammatory Nanoemulgels For Local Treatment Of Burn Wounds, Leah Dickey

Electronic Theses and Dissertations

Burns are some of the most traumatizing and damaging skin injuries, with the potential of causing extensive internal damage that increases the risk of chronic wound development. Oral and topical analgesics in combination with antibiotics can provide temporary relief and improve wound healing progress for both mild and severe burns. However, recurrent systemic exposure to pain relievers and antibiotics has been associated with adverse side effects including nausea, drowsiness, abdominal pain, etc., and increased risk of new infections or even ulcers. Local and targeted drug delivery systems, such as nanomedicine, have gained attention as potentially more effective alternatives to improve …

Development Of A Combined Feedforward-Feedback Quality Control System For Extended-Release Granules Using A Quality By Design Approach, Yuxiang Zhao

Electronic Theses and Dissertations

Objectives

For a fluid bed film coating process to consistently deliver quality products, its control system needs to be robust against the variability of input materials and environmental disturbances. Presently, limited studies have been reported to understand the effects and interactions of the material attributes, environmental variables, and process parameters on the product in vitro drug dissolution. A control system can be developed with a proper understanding of the coating process, by adjusting the process parameters in feedback and feedforward manners to compensate for the undesired effect caused by disturbances, and ensure consistent product quality.

Methods

The control system was …

Optimization And Characterization Of Hot-Melt Extruded Anti-Inflammatory And Local Anesthetic Bio-Adhesive Semisolid Formulation Using Design Of Experiments (Doe), Rishi Chinmay Thakkar

Electronic Theses and Dissertations

Hot melt extrusion is a versatile continuous manufacturing process extensively investigated for its applications with production of oral solid dosage forms, the aim of this study was to venture the applicability of HME in continuous manufacturing of topical semi-solid ointment formulations. Novel combination of a topical corticosteroid (Triamcinolone Acetonide) and local anesthetic (Lidocaine hydrochloride) were selected to be formulated with a water-soluble ointment base consisting of PEG 4000, PEG 1500 and Propylene glycol after performing appropriate drug-excipient compatibility studies. To determine the ratios of the solid to liquid components of the macrogol base, ‘quality by design’ approach was employed by …

Application Of Quality By Design And Process Analytical Technology Towards Hot-Melt Extrusion Processes, Priyanka Thipsay

Electronic Theses and Dissertations

Solid self-emulsifying drug delivery systems were developed instead of a conventional liquid system. Solid surfactants was chosen to emulsify lipids with different HLB properties. Type of surfactant, type of lipid, Lipid/surfactant L/S ratio, feed rate, screw speed and screw configuration, were the formulation and process parameters evaluated. Solid self-emulsifying drug delivery systems were successfully developed on the hot-melt extruder for the first time which is a continuous processing technology.

Solubility Enhancement Via Melt Extrusion: Drug-Polymer Solubility, Physicochemical Characterization And Quality By Design, Ketaki Patwardhan

Electronic Theses and Dissertations

Many new drugs developed face oral delivery challenges and absorption due to poor biopharmaceutical properties. Formation of solid dispersions is a very widely applied technique for solubility enhancement of water insoluble drugs. In order to form stable solid dispersions it is important to select appropriate excipients that will maintain the drug in its amorphous form for an extended period of time. Selection of appropriate excipients is critical during the development of stable amorphous solid dispersions. The solubility parameter concept has been explored for theoretically identifying the excipients that will be suitable based on the structure of the active. In this …