Study on Relative Bioavailability of Famotidine Sustained-release Tablets in Healthy Volunteers

The relative bioavailability of famotidine sustained release (SR) tablets was studied in 16 healthy male volunteers. Famotidine plasma concentration was determined by HPLC method, and the plasma concentration time data were processed with the method provided by USP XXIII. For single dose administration the peak plasma concentration occurring at 8 13±0 34 h was 69 52±3 00 ng/ml and the relative bioavailability was 112 4±8 6%. For multiple dose administration the peak plasma concentration of SR tablet was 86 14±2 95 ng/ml and the degree of fluctuation (DF) was 140 6±13 5% at steady state. Two one sided tests were performed in bioequivalence assessment. The results showed that the sustained release tablets were basically bioequivalent to the immediate release (IR) tablets on sale.

泮托拉唑与法莫替丁预防术后应激性溃疡的疗效对比研究

探讨泮托拉唑和法莫替丁在应激性溃疡疗效中效果。方法 将80例手术患者分成对照、研究组,对照组选择法莫替丁治疗,研究组选择泮托拉唑药物,比较疗效。结果 研究组术后应激性溃疡预防效果、胃液PH值和生活质量改善效果较高,不良反应发生率较低,P<0.05。结论 对于手术后应激性溃疡预防,选择泮托拉唑药物可取得理想效果,安全性高。

Synergistic action of famotidine and chlorpheniramine on acetic acid-induced chronic gastric ulcer in rats

AIM： To assess the synergistic action of famotidine （FMD） and chlorpheniramine （CPA） on acetic acid-induced chronic gastric ulcer in rats. METHODS： Chronic gastric lesions were induced in male Sprague-Dawley （SD） rats by serosal application of the acetic acid. Forty SD rats were randomly divided into blank group （n = 8）, control group （n = 8）, FMD group （n = 8）, CPA group （n = 8）, and FMD＋CPA group （n = 8）. Each group was given intraperitoneally （i.p.） 0.5 mL/100 g distilled water, 9 g/L NaCl saline, 4 mg/kg FMD, 10 mg/kg CPA, 4 mg/kg FMD＋10 mg/kg CPA, respectively, daily for 10 d, On d 10, ulcer area was determined by planimetry, The level of myeloperoxidase （MPO） in the liver homogenation was determined by biochemical methods and the plasma levels of 6-ketoprostaglandin F1 alpha （6-keto-PGFla）and IL-8 were determined by radioimmunoassay. RESULTS： The synergistic effects of FMD＋CPA group on the lesion, IL-8, 6-keto-PGFla and MPO were confirmed. The effect of FMD＋CPA group was significantly different as compared to the control and FMD groups. The lesion （mm2） was reduced from 40.18±2.6 in control group to 6.83±2.97 in PMD＋CPA group, P〈0.01, and from 32.9 ±3.27 in FMD group to 6.83±2.97 in PMD＋CPA group, P〈0.01. The plasma levels of IL-8 decreased from 0.69± 0.11 ng/L in control group to 0.4±0.04 ng/L in PMD＋CPA group, P〈0.01, and from 0.51±0.08 ng/L in FMD group to 0.4±0.04 ng/L in PMD＋CPA group, P〈0.05. The level of 6-keto-PGF1, increased from 7.55±1.65 ng/L in control group to 16.62±0.97 ng/L in PMD＋CPA group,P〈0.01, and from 13.15±1.48 ng/L in FMD group to 16.62±0.97 ng/L in PMD＋CPA group,P〈0.05. The levels of MPO in the liver homogenate decreased from 9.12±2.05 u/Lin control group to 4.33±0.95 u/L in PMD＋CPA group, P〈0.01, and from 8.3±1.29 u/L in FMD group to 4.33±0.95 u/L, P〈0.01. CONCLUSION： The synergistic action of FMD and CPA on acetic acid-induced chronic gastric ulcer in rats decreases the incidence of ulcer and also enhances the healing of ulcer.

Fused deposition modeling 3D printed oral famotidine pulsatile release tablets

The aim of this study was to prepare pulsatile release tablets which provide different drug delayed-release time and realize personalized administration according to the needs of patients.Fused deposition modeling(FDM)3D printing technology was introduced into the field of pharmaceutics in this study,and the feasibility to prepare core-shell pulsatile release tablets was explored by combing 3D printing technology with the traditional manufacturing technology.The core of the pulsatile tablets was a commercial tablet obtained from the traditional technology,and the drug-free shell was prepared by the FDM 3D printing technology.Three kinds of tablet shells were designed using different parameters.Furthermore,the morphology,size,weight,hardness,and in vitro drug release of the 3D printed famotidine pusatile tablets were characterized and evaluated.The results showed that the 3D printed tablets appeared intact without any defects.Different parameters of outer shell affected the size,weight,hardness,and in vitro drug release of the tablets.The tablets achieved a personalized delayed release time varying from 5 to 7 h in vitro.In this way,a new method for preparing pulsatile release tablets and a new way for the personalized administration of pulsatile tablets were explored in this study.