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Objective:To investigate the in vitro release behavior and stability of diphenyl diester suspension. Methods:The dis-solution of biphenyl diester dry suspension was detected by HPLC, and the effects of different stirring speed (50, 75, 100 r·min-1 ) and different dissolution media (pH 6. 8 phosphate buffer, 0. 05 mol·L-1 hydrochloric acid solution,water,pH 4. 5 acetate buffer) on dissolution were investigated. The influencing factors testing ( high temperature, high humidity and strong light exposure) , accelerated stability testing[the temperature of (37 ± 5) ℃ and the relative humidity of 76％ ± 5％] and long-term stability testing[(25 ± 3) ℃and the relative humidity of 60％ ± 5 ％] of biphenyl diester dry suspension were carried out. Results:The dissolution behavior of bi-phenyl diester suspension in pH 6. 8 phosphate buffer (50 r·min-1 ) was faster and smoother. The results of influencing factors testing showed that biphenyl diester dry suspension should not be stored under the conditions of high temperature and high humidity. After the samples were stored under the conditions of accelerated testing and long-term stability testing for 6 months, the indicators did not change significantly. Conclusion:The in vitro release of prepared biphenyl diester dry suspension meets the requirements with promis-ing stability.
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Objective:To optimize the formula and preparation process of prepare sorafenib dry suspension and detect the content by HPLC. Methods:The influence of single factor including different fillers, suspending agents, adhesives and disintegrants on the sedimentation rate, redispersibility and drying shrinkage of sorafenib dry suspension was observed. Orthogonal design was used to opti-mize the formula and preparation process of the suspension, and HPLC was used to determine the content of sorafenib. The chromato-graphic column was Inertsil ODS-3 (250 mm × 4. 6 mm, 5μm), the mobile phase was 20 mmol·L-1 ammonium acetate buffer-aceto-nitrile(28 ∶72), the detection wavelength was 266 nm, the flow rate was 1. 0 ml·min-1, the column temperature was 40℃, and the sample size was 20 μl. Results:The optimal formula and preparation process were as follows:sucrose (48%) was used as the filler, xanthan gum (28%) and CMC-Na (12%) were the suspending agents, MCC (10%) was used as the disintegrant, and 6% PVP (in 50% ethanol) was the adhesive. The linear range of sorafenib was 1-100 μg·ml-1(r=0.999 8), and the recovery was 98.96%(RSD=0. 75%, n=9). Conclusion:The optimal formula and preparation process are repeatable. The HPLC method is simple and specific, which can be used to determine sorafenib.
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Objective:To optimize the formula of artesunate dry suspension, and evaluate the quality. Methods:With sedimenta-tion volume ratio, redispersibility and loss on drying as the indices, single factor and orthogonal test were adopted to study the variety and amount of fillers, suspending agents, binders and disintegrating agents to optimize the formula. HPLC was used to determine the content of artesunate in the preparation. Different media and speed were used to investigate the dissolution behavior of artesunate dry suspension. The stability of the preparation was studied under the conditions of temperature (30 ± 2) ℃ and relative humidity (75 ± 5) % for four months. Results:The optimal formula of artesunate dry suspension was as follows: sucrose as the filler, xanthan gum (8%) and CMC-Na (12%) as the suspending agent, MCC (15%) as the disintegrant and 6% PVP K30 (in 50% ethanol solution) as the adhesive. Totally 4 batches of samples were prepared with the optimal formula, and their label contents were all above 95%, the sedimentation volume ratios were all higher than 0. 9 and the dissolution was more than 80% in 20 min. All the indices of samples met the requirements without significant change in 4 months. Conclusion:The preparation process of artesunate dry suspension is simple, reproducible and stable.
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Dry suspension is commercial dry mixtures that require addition of water at the time of dispensing. The major consequence of the bitter taste is to restrict greatly the further development of oral preparations and clinical applications of these drugs. People wish to take effective drugs that have a nice taste can be administered easily. Accordingly, it is important to mask the unpalatable taste of a drug in order to improve the product quality. The solvent evaporation process is used for microencapsulation which is carried out in a liquid manufacturing vehicle. Eudragit L100 is used as taste masking agent. FT-IR study shows that there is no significant interactions occurring between drug and excipients. The suspension prepared was evaluated for various parameters like sedimentation volume, degree of flocculation, drug content and In-vitro dissolution time. All the parameters were found to be within limits. When the results were compared with marketed preparation suspension was found to be better with respect to marketed preparation.
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Since its introduction, amoxicillin dry suspension has been the mainstay for the antibacterial therapy for paediatric patients. But use of substandard preparation of antibiotic is one of the most important causes of microbial resistance. The present study has been carried out to evaluate the quality and stability status of 10 marketed amoxicillin dry suspensions of Bangladesh. All the brands were analyzed for their potency using chemical and microbiological methods described in the United States Pharmacopoeia and British Pharmacopoeia. Potency determination was done at three controlled temperatures - refrigerated, room and elevated (40C) showed that two samples were over potent but one sample was substandard out of the 10 samples. The initial potencies of the two samples were within USP range when freshly reconstituted but after 7 days, at room temperature, potencies deteriorated and came down to 90%. In refrigerated condition, all the samples remained in good condition and at 40C, a considerable loss of potencies in all the samples were observed. Results of microbiological assay also support the results of chemical assay. The study emphasizes the necessity of routine inspection, monitoring and evaluation of quality of formulations containing amoxicillin dry syrup.
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OBJECTIVE:To determine the titer of main component in kitasamycin tablets and acetylkitasamycin dry suspension.METHODS:Staphylococcus aureus was used as test organism and which were cultured at (37?0.5) ℃ for about 4～5 hours by adding 1.0%～1.5% kitasamycin and 2.0%～2.5% acetylkitasamycin,then the absorbance was determined at a wavelength of 530 nm.RESULTS:The linear range of kitasamycin was 0.5～4.0 IU?mL-1 and that of acetylkitasamycin was 0.45～6.3 IU?mL-1,and their recovery rates were 101.7%(RSD=1.9%,n=9) and 101.1%(RSD=2.1%,n=9),respectively.CONCLUSION:The established turbidimetry is sensitive,rapid yet with few influencing factors,thus it is applicable for the titer determination of main component in kitasamycin tablets and acetylkitasamycin dry suspension.
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OBJECTIVE:To prepare taste-masked cefprozil dry suspension and establish its quality control method. METHODS: The suspension was prepared with glyceryl monostearin used as taste-masked agent and cefprozil as principal agent. The content of cefprozil was determined by HPLC,meanwhile the dissolution rate of the preparation was determined. RESULTS: The preparation was off-white or yellowish granula and it was up to the relative standard specified in Chinese Pharmacopeia (2005 edition) in inspection. The linear ranges of cis-isomer and trans-isomer of cefprozil were 0.05～0.5 mg?mL-1(r=0.999 9) and 5.0～50 ?g?mL-1(r=0.999 9),respectively. The average recoveries were 99.7%(RSD=0.32%,n=6) and 100.7% (RSD=0.23%,n=6),respectively. The preparation had a good taste and its dissolution rate within 45 minutes was as high as about 100%. CONCLUSIONS: The taste-masked cefprozil dry suspension has been successfully prepared by this method mentioned above;furthermore,the quality indexes of the suspension are up to the standard.