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At least 127 records · Page 7Linked to original sources

Hermetic packaging of drugs: optimized sealing of foil pouches.

Factors affecting the sealing of foil packages were studied in the sealing of foil packages were studied in three laboratories. The relationship of sealing temperature (with machine speed and pressure kept constant) to the incidence of defective packages was determined. The maximum acceptable limit for defective pouches was 1%. Three tests were employed to detect defects: vacuum-dye, seal strength, and pressurized ammonia vapor. Only the last was sensitive enough to determine the optimum sealing conditions. This test also was capable of detecting leakage sites. Replacement of the cellophane layer of the foil laminate with polyvinylidene chloride-coated polyester improved the barrier properties of the package.

Ammonia↗

Tracing the source of illicit drugs through plastic packaging--a database

Common plastic drug packaging material available in Australia and in Asia was analyzed using a standard protocol including optical examination, UV-visible and Fourier transform infrared spectrometry. The aims were to determine whether there are significant differences between different sources, to establish the evidential value of these examinations, and to build a database of common packaging material. Visual examination was the most effective means for discriminating samples. Thickness and weight measurements provided useful information. Visualization of machining marks using crossed polarized light was found to be useful in the comparison process. UV-visible spectrophotometry has some value for distinguishing samples. Fourier transform infrared analysis was a good technique for determination of the polymer composition of the packaging. Significant differences were observed between Australian and overseas samples. The "Australian Database of Drug Packaging Materials" was created to systematically collate all of the collected data for application on personal computers. It is concluded that the properties of plastic packaging materials can be excellent indicators for identifying the specfic brand or origin of the packaging.

Journal Article↗

Prescription drug products; patient package insert requirements--Food and Drug Administration. Final rule.

The Food and Drug Administration(FDA) is amending its patient package insert regulations to make the distribution requirements for patient package inserts for drug products in unit-of-use containers the same as the requirements for products in bulk containers. The agency is also amending its antibiotic drug regulations to permit manufacturers and distributors of antibiotics to make changes in labeling to comply with the patient package insert regulations without advance approval by FDA. This action will conform the requirements for implementing FDA's patient package insert regulations for antibiotics to the requirements currently applicable to the other drugs in the program.

Drug Labeling↗

[Treatment of iron deficiency anaemia in pregnant, puerperal and gynaecological patients--different drugs, different approaches].

UNLABELLED: According to WHO about 50 per cent of women of fertile age have iron deficiency anaemia (IDA). Iron loss > 80 mg per month, with menstruation in 22 per cent of women cause a negative iron balance in the course of time. About 40 per cent of women have data of prelatent iron deficiency still before conception, and if the demands of occured pregnancy are added, IDA is quickly reached. Over 30 per cent of puerperal women are affected by anaemia. PURPOSE: To make a pharmacoeconomic assessment of peroral antianaemic drugs used for treatment of IDA in pregnant, puerperal and gynaecologically ill women. MATERIALS: There are presented- daily intake of drugs, number of drug package taken, the price of a drug package, value of treatment a month, reimbursement of the drugs below: Ferro Gradumet, Maltofer Fol, Sorbifer Durules, Tot'hema, Legofer, Ferro-Folgamma, Tardiferon. RESULTS: The survey made and the data of own studies show that the most important in treatment of IDA are the choice of iron- containing drug and the correct therapeutic approach. The choice of peroral iron- containing therapy is determined by: high "patient compliance"--good tolerance, independence on food intake, once daily intake, low frequency of adverse effects and treatment with low price (economic effect). CONCLUSION: The most suitable for treatment of IDA in pregnant and puerperal women are Maltofer Fol and Sorbifer Durules. Maltofer Fol is with the best correlation price: "patient compliance". Tot'hema and Legofer have a good tolerance, a few adverse effects, but they are with high price. Ferro folgamma has not a high "patient compliance" and it has comparatively high price. Ferro gradumet has a low price and low "patient compliance".

Anemia, Iron-Deficiency↗

Internally concealed cocaine: analytical and diagnostic aspects.

Thirty persons arrested at Frankfurt airport for smuggling internally concealed cocaine in 1993/1994 were investigated. An X-ray examination (in all 30 cases), immunochemical examination of urine (in 27 cases) and of saliva (in 20 cases) was performed in parallel. An X-ray examination gave positive results in all examined persons. EMIT cocaine metabolite assay (cut off 300 ng benzoylecgonine (BE)/mL) was positive in eight urine samples. After reducing the cut off to 150 ng BE/mL urine, eleven samples were classified as positive. The results were confirmed by means of chromatographic determinations. These findings showed limited role of immunological examination of urine as a screening test in suspected smuggling of internally concealed drugs. All saliva samples showed negative immunochemical results. The number of concealed containers ranged from 44 to 135 per person. The amount of cocaine hydrochloride found in particular cases ranged from 242 to 1050 g net weight, divided into containers weighing from 5.7 to 13.8 g. Drug packages were obviously machine-made. The packages smuggled by a particular person were uniform. However, a distinct interpersonal variability in drug packages was observed, in regard to the number of protective layers (4-7), size, weight, and cocaine purity. This may be helpful for the identification of production site. The leaching of cocaine from selected containers was investigated in a stirring bath and was independent of the conditions applied.

Adult↗

Improvements in the packaging of drugs and chemicals may reduce the likelihood of severe intentional poisonings in adults.

Because of the inconvenience and longer time required to punch out the tablets, strip packaging may reduce the number of tablets that can be readily swallowed by adults with self-poisonings. In fact, hospital-based studies of paracetamol poisoning in the U.K. and Hong Kong have shown that blister packs were associated with fewer tablets being ingested and large overdoses were mostly from loose preparations. In Australia, following the change in packaging for carbamazepine from bottles of tablets to blister packs, a marked decrease in the reported number of tablets ingested by patients was seen. Reducing the maximum number of tablets that can be available in individual preparations or prescriptions may also reduce the likelihood of severe poisonings. In France, but not in the UK, the content of each pack of paracetamol has been legally limited to 8 g. This was thought to be one reason why severe liver damage and deaths after paracetamol poisonings are less common in France than in the UK. Medicated oils containing methyl salicylate pose the threat of rapid-onset, severe salicylate poisoning if swallowed. To reduce the amount of methyl salicylate that can be readily swallowed, the methyl salicylate content and the size of the bottle and its opening should be restricted. In adults with Dettol poisoning, serious complications such as pulmonary aspiration are more likely if a large amount is ingested. Similarly, the risk may be reduced by restricting the size of bottle and its opening.

Acetaminophen↗

Composition and cost of drugs stored at home by elderly patients.

BACKGROUND: Elderly people often have multiple chronic diseases, are frequently treated by several physicians, and also use over-the-counter medications. Excessive prescribing, imperfect therapeutic adherence, treatment modifications after hospitalization, and oversized drug packages result in home storage of leftover drugs, resulting in a waste of healthcare resources. PATIENTS AND METHODS: All patients aged >/=75 years hospitalized for >24 hours during a 6-month period in an urban teaching hospital in Switzerland were eligible for inclusion in a study collecting sociodemographics, medical, functional, and psychosocial characteristics. Six months later, a research nurse visited the patients at home and recorded the names, number of tablets, and expiration dates of all open or intact drug packages, and the doses actually taken. Acquisition costs of these drugs were computed. RESULTS: One hundred ninety-five patients were included (127 women; mean age 82.2 +/- 4.8 y, range 75-96). They had a total of 2059 drugs (mean per patient 10.3 +/- 6.7, range per patient 1-42), corresponding to a total cost of (US) $62 826 (mean per patient 322 +/- 275, range per patient 10-1571). Self-reported drug intake was regular for 36% of the drugs (46.5% of total costs) and occasional for 11% (6.1%), whereas 35.7% (30.1%) had been stopped during the last month. Cardiovascular drugs amounted to 36.6% of the drugs and 55.5% of the costs. None of the patients' characteristics was significantly associated with a greater number of drugs and higher costs. CONCLUSIONS: Drugs stored at home by elderly patients were worth about $320 per patient. Only about one-third of these drugs were regularly taken. In the context of resources shortage, innovative solutions should be found to reduce the waste linked with drugs stopped in previous months.

Aged↗

Premixed intravenous admixtures: a positive development for hospital pharmacy.

The development of premixed intravenous admixtures is reviewed in a historical context, and its effects on hospital pharmacy practice are discussed. As pharmaceutical manufacturers introduce more i.v. medications in ready-to-use containers, the same complaints that were voiced by pharmacists about unit dose packaging and ready-to-dispense tablets and capsules are being aired. But premixed i.v. admixtures are a logical extension of the basic unit dose principle of providing a readily identifiable and ready-to-administer dose. The time and cost savings these products offer are needed in hospital pharmacies. Some of the disadvantages of these products--including storage and freezer space and multiplicity of administration systems--are overcome by proper planning and education of personnel. If fewer personnel are now needed to prepare i.v. admixtures, then those personnel should be used to improve patient care in other ways. The use of premixed i.v. admixtures is a positive technological advance in drug packaging. Its advantages outweight its disadvantages, and it will soon be become the universally accepted form of i.v. drug packaging.

Drug Combinations↗

[Problems of geriatric patients with managing drug containers].

The purpose of the study was to measure the prevalence of difficulties in elderly inpatients in opening a range of common commercial drug packagings, in breaking a bar-scored tablet, and in reading medication instructions. Sixty-seven patients (female: 47; male: 20, mean age: 81.6 +/- 6.1) who reported that they had managed their medication independently before hospital admission, underwent a comprehensive geriatric assessment. They were also asked to remove tablets and drops from various commercial drug packagings and a "dosett", to break a tablet, and to read medication instructions enclosed in the packings. Only 21 patients (31%) were able to perform all tasks. Thirty-one patients (46.3%) failed in opening the "push and turn" bottle and 44 patients (65.7%) were unable to open the flip-top container. There were significant differences (p < 0.05) in age, cognitive capacity, handgrip, and manual dexterity between the patients who were able to perform all tasks, and those who were not able to do so. Many of the common medication packagings impede a reliable management of drugs by elderly patients.

Aged↗

Short-term chronoamperometric screening of chlorpromazine-package interactions.

A new electroanalytical method has been developed to measure and predict solute sorption interactions with solid surfaces. By maximizing surface-to-volume ratios, this method significantly reduces the study time of drug-package interactions and allows prediction of possible long-term effects. Chronoamperometry experiments were run in 40 microL drops of solution containing drug placed on a solid substrate disk of about 7 mm diameter in a sample cell designed to accommodate a miniaturized three-electrode setup. Logarithmic current signatures obtained by computing Delta(ln i)/Delta(ln t) were used to define the experimental conditions necessary to avoid the kinetic complications of chlorpromazine oxidation in the interpretation of the results of the chronoamperometric analysis. Results of sorption studies of chlorpromazine to glass, polypropylene, high density polyethylene, poly(ethylene terephthalate), ethylene vinyl acetate, and poly(vinyl chloride) are presented. The small volume sorption experiments demonstrated that chlorpromazine interacts most quickly with PVC and HDPE and least with glass and polypropylene. Long term stability tests confirmed these predictions, thereby indicating that the small volume method makes drug-package interaction studies feasible in early development. The generation and analysis of Delta(ln i)/Delta(ln t) signature curves extends the usefulness of the electroanalytical method to other systems by accurately identifying the appropriate time domains for steady state or Cottrell behavior.

Chemistry, Pharmaceutical↗