Formulation Development and Evaluation of Ubidecarenone Chewable Tablets

Rajesh Kumar, N (2012) Formulation Development and Evaluation of Ubidecarenone Chewable Tablets. Masters thesis, College of Pharmacy, Madras Medical College, Chennai.

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Aim: To formulate Ubidecarenone chewable tablet containing 400mg and to evaluate organoleptic characters such as taste and flavour along with in vitro release studies. Plan of the work: Pre-formulation studies Drug- Excipent compatability studies, Assay Water content In process Quality Control Checks for derived properties like Bulk Density, Tapped Density, Compressibility Index, Hausner’s Ratio and Angle of Repose for drug and blends to be determined. Optimization of concentration of ingredients such as Flavours, Sweeteners, Disintegrant, Wetting agent, Glidant and Lubricant. Formulation of Chewable tablets with optimized ingredients. Evaluation of chewable tablets for post compression parameters like Uniformity of Weight, Thickness, Hardness, Friability, Disintegration Time, Assay and in vitro drug release characteristics to be studied. Palatability test has to be done for the optimized batch. Accelerated Stability Studies of the Ubidecarenone chewable tablets packed in 75 cc Amber coloured HDPE Bottle with 33 mm PP Child Resistant Cap with Induction sealed having 1 g of 6 g / yard cotton as dunnage, and 2 no’s of 1 g Silica gel canister as desiccant; shall be determined at 40 ± 2°C / 75 ± 5% RH at one month interval for 3 months and the following are used as raiders for evaluation while comparing with Initial, Appearancem, Uniformity of weight,Thickness and Hardness, Disintegration Time, Water content, Assay . Dissolution studies SUMMARY AND CONCLUSION:The aim of the present study was to formulate Ubidecarenone chewable tablets and was achieved. Ubidecarenone raw material had poor flow characteristics. Hence, it was blended using directly compressible excipients which improve the flow property of the blend and chewable tablets were formulated by direct compression. The excipients used in the formulation were subjected to Drug- Excipient compatibility study and found that the excipients were compatible with the drug. Optimization study for flavouring agent was conducted and found that the Combination of Orange flavour (0.83%) and Mint flavour (0.21%) were found to be palatable. Optimization study for sweetening agent was conducted and as a result 1.66% of Aspartame and 0.42% of Saccharin Sodium were optimized and it was used to get good sweet taste. 5% of Crospovidone (Polyplasdone XL 10) was optimized to get a rapid disintegration of tablets. Poloxamer 407 (Lutrol Micro 127 in 0.83%) produced a drug release of 88.25% at the end of 45 minutes and it complies with USP limits. Thus it was optimized as good wetting agent. Colloidal Silicon Dioxide (Cabosil in 0.5%) and Sodium Stearyl Fumarate (Pruv in 0.5%) were optimized as the glidant and lubricant to produce tablets without sticking, picking and striation. The optimized formulation blend has a good flow property based on its angle of repose value. The optimized formulation blend (E III) was compressed by direct compression technique in 16 station tablet compression machine using 21 x 10 mm caplet shaped punches. The formulated chewable tablets were evaluated for post compression parameters and found that they were uniform in weight, thickness and hardness. The friability was within the limits. The disintegration time of chewable tablets for finalized batch (E III) was 1 minute 45 seconds. � The drug content of the chewable tablets was 98.14% and is within the USP limits (90-110%). Drug release of 88.25% was observed at the end of 45 minutes and 99.75% at the end of 90 minutes for optimized batch (E III) and it was within the USP limits. The formulated chewable tablets were subjected to accelerated stability studies and the tablets were found to be stable. The Ubidecarenone in the form of chewable tablets (400mg) will improve the compliance of Parkinsonism patients.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Ubidecarenone Chewable Tablets
Subjects: PHARMACY > Pharmaceutics
Depositing User: Ravindran C
Date Deposited: 02 Feb 2018 11:54
Last Modified: 02 Feb 2018 11:54

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