Bupropion Hcl Case Study

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5. RESULTS AND DISCUSSION 5. RESULTS AND DISCUSSION The present study was undertaken to formulate a extended release tablet dosage form containing a core tablet on which polymeric layers are coated which extends the release. These polymeric layers undergo different rates of swelling and drug release by diffusion process. A) API Characterization: Table 5.1: Organoleptic properties of Bupropion HCl S.No. Properties Results 1 Description White powder 2 Taste and Odour Highly bitter & Odourless 3 Color Colorless Inference: By observing the Organoleptic properties, the given Bupropion HCl was found to be white powder, highly bitter, odourless and colorless. Determination of melting point. The melting point of the Bupropion HCl was determined…show more content…
The standard graph constructed conferred that the concentrations of drug ranging from 6 to 16 µg/ml obeyed the beer lambert principle. Moreover, the calibration curve of Bupropion HCl exhibited a good correlation between the concentrations and the absorbance in this range (R2 = 0.999). Solubility analysis Solubility data of Bupropion HCl Table 5.3 S.No. Medium Approximate pH Solubility (mg/ml) Dose/solubility Ratio 1 0.1N HCl 1.2 310.36 0.966 2 pH 4.5 Acetate Buffer 4.5 1197.58 0.250 3 pH 6.8 Phosphate Buffer 6.8 273.78 1.095 4 pH 7.4 Phosphate Buffer 7.4 364.56 0.822 5 Purified water 6.02 272.97 1.099 Inference;From the above data it was observed that Bupropion HCl was soluble over the observed pH (1.2 to 7.4). DRUG- EXCIEPIENT COMPATIBILITY STUDY Table No: 5.4Results of Compatibility study S.No Name of the Excipient Ratio API: Exp Initial Observation 50°C Final observation Conclusion 40°C/75% RH 2nd week 4th week 1 API (Bupropion hydrochloride) --- White ---- White White…show more content…
So go for second trail F2 (15% ER coating) F2 Trail also retards the release does not comply with the USP limits and innovator.So go for third trail (10% ER Coating) F3 trail shows burst release so increases the ER coating.F4 (12% ER coating) F4 Trail matches with the innovator.so for conformation go for another trail with the same percentage of coating.so go for another trail F5 to get the reproducability. There is no reproducability between F4 and F5 trail .Hence change the polymer grade from Ethylcellulose 10 cps toEthylcellulose 15 cps.Hence go for another trail F6 12%Coating of ethylcellulose 15 cps. F6 Shows retarded release hence decreases the % of coating hence go for another trail F7. F7 shows retarded release hence go for another trail F8 decreases the %of coating. F8 shows burst release hence go another trail F9.Increases the % of coating.F9 matches with the innovator.To get more reproducability go for another trail with % of coating with the same grade polymer. Fig 5.3 Both F9 and F10 shows reproducability both are compile wiith the
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