Pharmaceutical Manufacturing Companies Research Articles

Kinetic and equilibrium studies on the biosorption of reactive black 5 dye by Aspergillus foetidus

An isolated fungus, Aspergillus foetidus had the ability to decolourize growth unsupportive medium containing 100 mg L −1 of reactive black 5 (RB5) dye with >99% efficiency at acidic pH (2–3). Pre-treatment of fungal biomass by autoclaving or exposure to 0.1 M sodium hydroxide facilitated more efficient uptake of dye as compared to untreated fungal biomass. Pre-equilibrium biosorption of RB5 dye onto fungus under different temperatures followed pseudo-second-order kinetic model with high degree of correlation coefficients ( R 2 > 0.99). Biosorption isotherm data fitted better into Freundlich model for lower concentrations of dye probably suggesting the heterogeneous nature of sorption process. Based on the Langmuir isotherm plots the maximum biosorption capacity ( Q 0) value was calculated to be 106 mg g −1 at 50 °C for fungal biomass pre-treated with 0.1 M NaOH. Thermodynamic studies revealed that the biosorption process was favourable, spontaneous and endothermic in nature. Recovery of both adsorbate (dye) and adsorbent (fungal biomass) was possible using sodium hydroxide. Recovered fungal biomass could be recycled number of times following desorption of dye using 0.1 M NaOH. Fungal biomass pre-treated with NaOH was efficient in decolourizing solution containing mixture of dyes as well as composite raw industrial effluent generated from leather, pharmaceutical and dye manufacturing company.

Customer relationship management in the contract pharmaceutical industry: an exploratory study for measuring success

Managing customer relationships is a very important issue in business-to-business markets. This research investigates the growing number of available resources defining Customer Relationship Management (CRM) efforts, and how they are being applied within the Contract Pharmaceutical Manufacturing industry. Exploratory study results using face-to-face and telephone questionnaires based on four criteria for rating a company's CRM efforts are presented. Data was collected from large Contract Pharmaceutical Manufacturing companies in the US market. The results and conclusions are discussed relating how the Contract Pharmaceutical Manufacturing industry is implementing CRM including some potential steps to take when considering a CRM initiative.

Incidence of allergy and allergy symptoms among workers exposed to laboratory animals

Background and Aims: Few studies have described relations between exposure to laboratory animals and the incidence of laboratory animal allergy (LAA). Studies that have found exposure-response relations have been cross...

A Two‐Way Cross‐Over Bioequivalence Study Comparing Two Products of Diclofenac Sodium Suppositories in Healthy Human Volunteers

This report presents the results of two treatment cross-over investigations on 20 healthy male volunteers to assess the bioequivalence of two suppository products of diclofenac sodium. The study was carried out under US Food and Drug Administration Guidelines. The two products were voltaren (100 mg) suppository (Ciba-Giegy), as a reference product, and Inflaban (100 mg) suppository (The Arab Pharmaceutical Manufacturing Company, Ltd. "APM"), as a test product. Both products were administered rectally as a single dose (100 mg) separated by a one-week wash-out period. Following drug administration, blood samples were collected over 12 hr, and serum harvested from the blood was analyzed for diclofenac sodium using a sensitive and specific high performance liquid chromatographic assay. The results of this investigation indicated that there were no statistically significant differences between the two products in either the mean concentration-time profiles or in the obtained pharmacokinetic parameters, including area under the serum concentration-time curve for 12 hr (AUC(0-12h)), lag time between product administration and first appearance of the drug in serum (T(lag)), peak serum concentration (C(max)), and time to reach this peak serum concentration (T(max)). Concerning the relative extent of absorption, assessed by the AUC ratio (Inflaban/Voltaren) for 12 hr, the average value was found to be 1.00+/-0.09 with a 95% confidence limits (C.L.) of 0.82-1.18. Thus, these findings clearly indicate that the two products are bioequivalent in terms of rate and extent of drug absorption.

The 1998 domestic state of development of cognitive enhancers

Recently, there is a great social problem that geriatric disorders, especially senile dementia, are growing rapidly with the increasing percentage of aged individuals in the total population. However, there is yet no drug that has reliable effects on senile dementia on the market. Therefore, society requires the development of new drugs that can support patients so that they can smoothly live their daily lives by themselves. In this study, we attempted to investigate the 1998 domestic state of development of cognitive enhancers by summarizing many publications and by gathering questionnaires from pharmaceutical, food, synthetic fiber and chemical manufacturing companies. There were 40 currently investigated cognitive enhancers in Japan as of the end of March, 1999 including 37 newly synthesized compounds and 3 new dosage forms or applications of additional effects. On the classification according to the mechanism of drug action, 12 of the investigated drugs are cholinomimetic agents, 12 are ameliorators of neuronal transmission, 1 is an intracellular mediative substance, 3 are neuropeptides, 2 are cerebral metabolic activators, 2 are cerebral circulation enhancers and 7 are neuronal cell protectors, and 1 is another type. For dementia of the Alzheimer's type, there are 1, 3, 10 and 2 drugs in prerecognition, phase late II, early II and I of clinical trials, respectively. For cerebrovascular dementia and cerebrovascular disease, there are 19 drugs being investigated. Seven of these compounds such as E2020 (donepedil HCl), DM-9384 (nefiracetam), TA-0910 (taltirelin), NS-3 (montirelin), TTC-909 (clinprost), DR-3305 (ebselen) and AVS (nicaraven) are at the prerecognition stage for marketing. It is important that effective cognitive enhancers will be supplied for clinical stage use as soon as possible.

Liver damage in pharmaceutical industry workers.

A group of workers who were employed at a pharmaceutical manufacturing company and who participated in the entire production cycle were studied. Numerous substances, including iodo-chloro-oxyquinoline, erythromycin, disinfectants, small amounts of cortisones, and preserving agents (prevan and parabenzoates), were used in the manufacturing processes. A control group comprised individuals who were not exposed to hepatotoxic substances. This investigation was designed to determine the risk of hepatotoxicity in the pharmaceutical industry, and a protocol was used that allowed for ease of screening. In the presence of a physician, all subjects completed a clinical history questionnaire. They all underwent a general clinical examination, and specific blood chemistry tests were performed. Certain liver indices that were correlated with cytotoxicity were significantly higher in the pharmaceutical workers than among the controls. The findings confirmed that there was a problem of hepatic involvement among workers in this sector, indicating that the clinical-biohumoral screening protocol used in this study was valid for identifying subjects at risk of hepatotoxicity.

Pharmacoeconomic Analysis of Drug Therapy.

Pharmacoeconomics has become a topic of great interest throughout the world. It broadens the analysis of drug products beyond safety and efficacy issues and evaluates the costs and consequences (outcomes) of drug products. It goes beyond focusing primarily on drug product acquisition cost and evaluates the total costs and benefits to the health care system. The four types of pharmacoeconomic analysis are cost-minimization, cost-effectiveness, cost-utility, and cost-benefit. These four methodologies differ in their measurement of the costs (inputs) and outcomes (outputs) of drug therapy. These methodologies are useful in determining the highest quality of care for the money spent. Pharmacists, physicians, hospitals, insurance companies, pharmaceutical manufacturing companies, and governments are interested in pharmacoeconomic analysis in order to provide efficient outcomes and cost-effective assessments. Direct costs describe health care resources used in providing a product or service. Indirect costs describe the loss of human productivity that may be seen from lost work because of illness or its treatment. Intangible costs describe costs such as pain or quality of life issues. The study perspective (viewpoint) significantly determines how costs and benefits are evaluated, such as governments, hospitals, insurance providers, or pa.-dents. Sensitivity analysis is important to determine the effectand extent of analysis uncertainties. Common pharmacoeconomics uses and a description of methodologies are reviewed.

Establishing a Rehabilitation Program for Impaired Pharmacists

The Texas Pharmaceutical Association (TPA) rehabilitation program for impaired pharmacists and pharmacy students is described. Since its inception in 1983, the TPA Pharmacists Rehabilitation Program has provided assistance to impaired pharmacists and pharmacy students, as well as their families, friends, customers, and coworkers. The program uses a carefully developed intervention process designed to assist impaired pharmacists and pharmacy students in obtaining evaluation and treatment of their condition. After a referral, an appointment is made for the impaired person at 1 of 15 regional evaluation and referral centers across the state, where arrangements for appropriate treatment are made. After treatment, the Committee on Pharmacists Rehabilitation aids the pharmacist or student in reentering the profession or returning to school. Intervenors are pharmacists registered in the state of Texas who have participated in TPA's training sessions; TPA also provides an intervenor's workbook. Amendments to the Texas Pharmacy Act passed in 1983 and 1985 provide protection for intervenors who are working with pharmacists and pharmacy students with impairment problems. Referrals are made by means of a 24-hour, toll-free hotline funded by a pharmaceutical manufacturing company. Other funding comes from individual donors, member associations affiliated with TPA, chain drugstores, wholesalers, and the Texas State Board of Pharmacy. A successful rehabilitation program for impaired pharmacists and students must be carefully designed and implemented, with attention paid to legal, financial, and intervention-related issues associated with substance abuse.

Filter-Down Theory: Location and Technology in the UK Pharmaceutical Industry

This paper presents an examination of filter-down theory in relation to the location and technological sophistication of manufacturing establishments within the UK pharmaceutical industry. By means of data drawn from a survey of eighty-three pharmaceutical manufacturing companies, the paper considers the technological sophistication both of firms and of plants according to their location as defined by settlement size, degree of urbanization, and their broader centre-periphery regional setting. Given the overall location of the UK pharmaceutical industry, it is shown that there is no significant technological bias in favour of firms or plants located in larger settlements, in more urbanized areas, or within more centrally located regions. In part this result was associated with the decentralized location of manufacturing units controlled by large technologically advanced corporate organizations. The survey data also revealed that on an intracorporate basis there was no evidence that more distant plants, in relation to their main innovation or headquarters location, tended to be less technologically sophisticated.

The Development of a Decision Making Framework For Logistics Management

An Aid to Decision Making Following on from the earlier article in the previous issue of this Journal, when the systems approach to logistics decision making was introduced, this second and final part describes the development of a set of heuristic rules. Using these as a formalised aid to everyday decision making by manufacturing companies, the total logistics analysis may be simplified. The development and testing of these decision rules were carried out as part of a programme of research work amongst a number of pharmaceutical manufacturing companies.

The Development of a Decision Making Framework for Logistics Management: I. The Systems Approach

Consideration of logistics, or distribution, operations in their total corporate context usually involves too complex an analysis for use in everyday decision making. During a research programme recently carried out amongst pharmaceutical manufacturing companies, a set of rules was developed as an aid to decision making, which would simplify such an analysis. The details of this step forward in formalised decision making for logistics management are set out in a two‐part article, the first of which appears here.