#TITLE_ALTERNATIVE#

• Main Author: WIDYASTUTI NIM: 20715028, INDAH
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/28028
• Institution: Institut Teknologi Bandung

During manufacturing process of dosage forms, the physical properties of active <br /> <br /> pharmaceutical ingredients is very influencing on the quality, safety, and efficacy. <br /> <br /> Many active pharmaceutical ingredients were reported to be in the form of <br /> <br /> hydrates. Ciprofloxacin hydrochloride can exist on form of anhydrate and <br /> <br /> monohydrate. Water content cause on hydrolysis, hygroscopisity, bonding, and <br /> <br /> crystal properties of the active pharmaceutical ingredient. Ciprofloxacin <br /> <br /> hydrochloride is widely used in the world as an antibacterial agent, it can be <br /> <br /> assigned to Biopharmaceutics Classification Systems (BCS) Class IV and must be <br /> <br /> conducted on bioequivalence study. Ciprofloxacin hydrochloride can be <br /> <br /> formulated into tablet dosage forms with the 500 mg strength. Characterization it <br /> <br /> carryout in order to observe the physicochemical character of ciprofloxacin <br /> <br /> hydrochloride monohydrate after thermal energy, mechanical and solvents. The <br /> <br /> aim of this study was studying the physicochemical characterization of two <br /> <br /> different sources of ciprofloxacin hydrochloride monohydrate. Ciprofloxacin <br /> <br /> hydrochloride monohydrate were characterized by infrared spectroscopy, <br /> <br /> differential scanning calorimetry (DSC), Thermal gravimetri analysis (TGA), and <br /> <br /> powder X-ray diffraction (PXRD) method. Besides, it also done the termination of <br /> <br /> water content by Karl Fischer, crystal habit, powder flow properties, elastic <br /> <br /> modulus, solubility and dissolution testing. To understand the influence of thermal <br /> <br /> energy, ciprofloxacin hydrochloride monohydrate was heated in 40, 110 and <br /> <br /> 180°C. On the otherside, to understand the effect of the mechanical energy was <br /> <br /> grinding for 180 minutes and compressed in 4.9, 19.6 and 24.5 kN compression <br /> <br /> force. The effect of solvent was studied by recrystallization under it from water <br /> <br /> and ethanol 96%. After treatment was characterized by DSC and PXRD method, <br /> <br /> and also determination of crystal habit, water content and dissolution testing. <br /> <br /> There was no difference in physicochemical characteristic between two different <br /> <br /> sources of ciprofloxacin hydrochloride monohydrate. Both material of <br /> <br /> ciprofloxacin hydrochloride monohydrate were relatively stable at 40, 110 and <br /> <br /> 180°C. Ciprofloxacin hydrochloride anhydrate was not formed after heating <br /> <br /> because during cooling ciprofloxacin hydrochloride absorbed water vapour from <br /> <br /> environment and became ciprofloxacin hydrochloride monohydrate. <br /> <br /> iv <br /> <br /> Grinding induced particle size reduction and decreased crystallinity. There was <br /> <br /> change the water content of ciprofloxacin hydrochloride monohydrate. <br /> <br /> Compression force induced increased the water content and sintering. There was <br /> <br /> no change hydrate transformation during recrystallization in water and ethanol <br /> <br /> 96%. After room temperatur, the water content of ciprofloxacin hydrochloride <br /> <br /> monohydrate changed. Dissolution rate was affected after recrystallization and <br /> <br /> compression process. Therefore API source, solvent and humidity during process <br /> <br /> must be controlled. <br /> <br />