摘要:

AbstractFour commercially available automatic weighing systems were comparatively evaluated with a Mettler H20T semimicro balance, manually operated, serving as a control.The approach to the study was to choose 50 test units randomly from five different products (tablets and capsules) with average weights ranging from as low as 125 mg per unit to as high as 750 mg per unit. Each unit from each product was assigned a number from 1 through 50 and was weighed on all five weighing systems in a random sequence. In a second series of measurements one unit of each product, selected randomly, was weighed 20 times on each of the five weighing systems. Data from both series were statistically analyzed and evaluated.Results were similar in both series of experiments and indicated that the Cahn automatic weighing system exhibited the most variability. The Scientech automatic weighing system was the second most variable followed by the other two automatic weighing systems; Sartorius and Mettler. The Mettler H20T, the control, was the least variable. The geometric averages for each product among the weighing systems were statistically different (P≤0.05); however, the magnitude of these differences was considered not large enough to be of any practical pharmaceutical interest.The important features of each of the automatic weighing systems are presented and an attempt is made to explain the variabilities observed.

ISSN:0363-9045    

DOI:10.3109/03639047909069226

出版商:Taylor&Francis    

年代:1979

数据来源: Taylor

摘要:

AbstractThe use of stability testing and expiration dating as a tool for assuring product integrity is generally accepted by pharmaceutical companies and governmental agencies alike. Equally accepted is the notion that it would be impossible for anyone to forward one simple stability testing formula or rule for reasonably assuring the integrity of every product of every manufacturer. In fact, within The Upjohn Company, widely differing concerns arise with respect to stability testing as a proposed new product matures into established product status. The purpose of this presentation is to discuss some of the objectives and operational procedures used at Upjohn with respect to the stability testing of a product at various stages in its existence.

ISSN:0363-9045    

DOI:10.3109/03639047909069227

出版商:Taylor&Francis    

年代:1979

数据来源: Taylor

摘要:

AbstractThree commercially available antacids, two of them labeled either to be taken intact or to be chewed, (Bisodol®, Maalox®No. 1) and one of them (Riopan®) available in two formulations, chew tablets and swallow tablets, were testedin vitrofor disintegration time, pressure resistance, acid consumption capacity and acid neutralizing capacity and in vivo in man using the Heidelberg Capsule. The total areas under thein vivopHversustime curves obtained with the intact and chewed tablets, respectively, corrected for the individual NaHCO3response test were determined. Also the time to reach pH 3 and the period of time for pHversustime curve above pH 3 were determined. The preparations were evaluated for extent of antacid capacity, efficacy and lag time. From the results obtained it becomes evident that by chewing rather than swallowing the antacid intact tablet, a quicker and more effective relief is obtained.

ISSN:0363-9045    

DOI:10.3109/03639047909069228

出版商:Taylor&Francis    

年代:1979

数据来源: Taylor

摘要:

AbstractThe performance of the air-jet sieve (AJS), for the particle size analysis of pharmaceutical powder, was evaluated and compared with the conventional sieve shaker (ESS). Two grades of acetaminophen (APAP) were used as test pharmaceutical powders. The particle size analysis by the AJS was simple, reproducible, efficient and accurate. The problematic powder, possessing excessive electrostatic charges and ranging in mean diameter from 17 nm to 800 nm (beyond the scope of ESS) could be evaluated accurately by AJS. The analysis time required by AJS was relatively less than that required by ESS. The accuracy of the determination by AJS was not affected by the sample size. Both the speed of rotation (vibrations and/or shaking) and the total time of sifting affected the results of the determination by ESS. The particle size value of APAP-special determined by ESS and AJS were 680.0±0.14 nm and 40.0±0.32 respectively, whereas the value assigned by the manufacturer was below 74 nm (-200 mesh). The precision of either method for particle size analysis of powder possessing excessive electrostatic charge was improved by the use of carbon black as an anti-static agent.

ISSN:0363-9045    

DOI:10.3109/03639047909069229

出版商:Taylor&Francis    

年代:1979

数据来源: Taylor

摘要:

AbstractFluidized bed coating with ethyl cellulose., polyethylene glycol mixtures has been utilized for prolongation of drug release from granules containing salicylic acid and caffeine as model drugs. Drug release from the coated granules followed first order kinetics.Particle size of the active material, granule composition and extraction medium pH did not affect the rate and kinetics of drug release. Increase in coat thickness decreased the release rate whereas elevation of the ratio of polyethylene glycol to ethyl cellulose enhanced the release rate to a degree related to the polyethylene glycol concentration. The permeability constants of salicylic acid and caffeine for the ethyl cellulose-polyethylene glycol coatings were of a similar order to those measured previously using solutions of the drugs with planar barrier films.

ISSN:0363-9045    

DOI:10.3109/03639047909069230

出版商:Taylor&Francis    

年代:1979

数据来源: Taylor

ISSN:0363-9045    

DOI:10.3109/03639047909069231

出版商:Taylor&Francis    

年代:1979

数据来源: Taylor

ISSN:0363-9045    

DOI:10.3109/03639047909069225

出版商:Taylor&Francis    

年代:1979

数据来源: Taylor