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PubMed2002

Comparative stability studies of antipseudomonal beta-lactams for potential administration through portable elastomeric pumps (home therapy for cystic fibrosis patients) and motor-operated syringes (intensive care units).

The stability of antipseudomonal beta-lactams in concentrated solutions was examined in view of their potential administration by continuous infusion with external pumps (for intensive care patients) or with portable pumps carried under clothing (for cystic fibrosis patients). Aztreonam (100 g/liter), piperacillin (128 g/liter, with tazobactam), and azlocillin (128 g/liter) remained 90% stable for up to more than 24 h at 37 degrees C (mezlocillin [128 g/liter] was stable at 25 degrees C but not at 37 degrees C). Ceftazidime (120 g/liter), cefpirome (32 g/liter), and cefepime (50 g/liter) remained 90% stable for up to 24, 23.7, and 20.5 h at 25 degrees C but only for 8, 7.25, and 13 h at 37 degrees C, respectively. The control of temperature therefore appears to be critical for all three cephalosporins that cannot be recommended for use in portable pumps carried under clothes for prolonged periods for reasons of stability. Cefpirome and cefepime solutions developed an important color change (from light yellow to dark red) upon exposure when stored at 30 degrees C or higher. Degradation of ceftazidime was accompanied by the liberation of pyridine which, at 37 degrees C, was in excess of what is allowed by the U.S. Pharmacopeia, i.e., 1.1 mg/liter, after 8 and 12 h for drug concentrations of 12 and 8.3%, respectively. Imipenem and meropenem are too unstable (10% degradation at 25 degrees C after 3.5 and 5.15 h, respectively) to be recommended for use by continuous infusion. Faropenem, examined in comparison with imipenem and meropenem, proved as stable as aztreonam or piperacillin.

Anti-Bacterial Agents↗
PubMed1992

Development of a universal diluting fluid for membrane filtration sterility testing.

A universal diluting fluid (UDF) was developed for use in membrane filtration sterility testing. Diuting fluid is used to free the filter membrane of preservative residues which could inhibit microbial recovery. Current procedures employ one of several fluids described by the United States Pharmacopeia. UF was designed to utilize the neutralizing capabilities of a combination of inactivating agents while minimizing any inherent microbial toxicity. This formulation eliminates the need for multiple types of preservative-specific diluting fluids. Its neutralizing effectiveness was examined against several common preservative agents used in health care products. UDF provides significantly better microorganism recovery than dilution alone among a wide range of preservative classes.

Bacteria↗
PubMed2004

Therapy of falciparum malaria in sub-saharan Africa: from molecule to policy.

The burden of falciparum malaria remains as great as ever, and, as has probably always been the case, it is carried mainly by tropical Africa. Of the various means available for the control of malaria, the use of effective drugs remains the most important and is likely to remain so for a considerable time to come. Unfortunately, the extensive development of resistance by the parasite threatens the utility of most of the affordable classes of drug: the development of novel antimalarials has never been more urgently needed. Any attempt to understand the vast complexities of falciparum malaria in Africa requires an ability to think "from molecule to policy." In consequence, the review ambitiously tries to examine the current pharmacopeia, the process by which new drugs are developed and the ways in which drugs are actually used, in both the formal and informal health sectors. The informal sector is particularly important in Africa, where around half of all antimalarial treatments are bought from informal outlets and taken at home without supervision by health care professionals: the potential impact of adherence on clinical outcome is discussed. Given that the full costs are carried by the patient in a large proportion of cases, the importance of drug affordability is explored. The review also discusses the splicing of new drugs into national policy. The various parameters that feed into deliberations on changes in drug policy are discussed.

Adolescent↗
PubMed1994

History of medicine and nephrology in Asia.

The beginning of Chinese medicine has been attributed to 3 mythical emperors who gathered herbs for medicines. During the 2nd century BC, Han dynasty physicians developed cranial trephining and sedation with wine and herbs for anesthesia. Chiang Chung-Ching (142-212 AD) used the appearance of rashes in diagnosis, treated infections with anthelmintics and asthma with ephedra, described the symptoms of diabetes mellitus and expanded medical ethics. The specialties of obstetrics, pediatrics, ophthalmology and dentistry were described in the records of the Han and Tang dynasties, and methods of setting fractures and treating trauma were comparable with those of Roman military doctors. Shen Tua (1031-1095 AD) compiled a pharmacopeia and studied acupuncture and the pulses. Forensic medicine was developed during the 10th century by Sung Tse, who also advocated hand washing with sulfur and vinegar to avoid infection during autopsies. The Daoist physicians used androgens and estrogens to treat hypogonadism with therapeutic preparations of placentas. They also had an advanced knowledge of alchemy, claiming to achieve 'immortality' by their preservation techniques. Qualifying examinations for physicians were conducted by the Chinese state as early as the 1st century AD, and later incorporated philosophy and art to conform with the Confucian ideal. Throughout these eras, Chinese medicine profited from contact with western Asia. In ancient Chinese medicine, the excretory function of the kidney was attributed to the bladder. 'Kidney weakness', which refers to somatized depression, was treated by acupuncture along the 'kidney channel'. Pulse examination was also used to give a measure of the imbalance of renal Yin and Yang.(ABSTRACT TRUNCATED AT 250 WORDS)

Alchemy↗
PubMed1994

Joseph Jacob Plenck (1735-1807).

Joseph Jacob Plenck (1735-1807) is considered to be the forerunner of modern European dermatology, who also compiled a list of about 800 plants with medicinal uses. Of these about 115 have diuretic properties and are currently included in various pharmacopeias. They were traditionally used to cure ascites of various causes, in urolithiasis, nephritis, cystitis, bladder ulcers, strangury, urinary retention and incontinence. Few of these plants have been fully investigated by modern medicinal chemists, and many are worthy of further study.

Austria↗
PubMed1994

Useful plants in renal therapy according to Pliny the Elder.

The Naturalis Historia of Pliny the Elder consists of 37 books, of which 16 are devoted to botany. About 900 plants are named, but many names are synonyms and identification is often impossible. Where identification is possible it is achieved by comparison of the actual names with the vernacular names in related languages or by indirect evidence from their medical use. In this way 130 plants used in renal therapy during Roman times can be identified. Many were eaten as part of the diet, and the distinction between medicinal and edible plants was not clearcut. Pliny was also the first author to comment that wild species are more active than cultivated ones. Most of the plants reported by Pliny are also mentioned by Dioscorides, and more than 30 of them were also listed by Plenck. Several are still quoted in modern pharmacopeias.

History, Ancient↗
PubMed1996

How accurate is serologic testing of plasma pools for hepatitis B virus surface antigen, anti-human immunodeficiency virus 1 and 2, and anti-hepatitis C virus?

OBJECTIVE: The European pharmacopeia prescribes that, during the manufacture of blood derivates, the first homogeneous pool of plasma (for example, after removal of cryoprecipitate) must be tested for hepatitis B virus surface antigen (HBsAg), for hepatitis C virus (HCV) antibodies and for human immunodeficiency virus (HIV) antibodies using test methods of suitable sensitivity and specificity, in order to reduce the residual risk of infection originating from blood products. The present study was performed to verify if commercially available immunoassays, which are licensed for the screening of single serum and plasma samples, are suitable for the determination of HBsAg, anti-HCV, and anti-HIV in plasma pools. DESIGN: Plasma tools originating from different countries were spiked with HBsAg- and anti-HCV-positive standards (National Institut für Biological Standards, Hertfordshire, UK) and anti-HIV-positive serum. For the determination of HBsAg with and without immune complex dissociation (ICD), anti-HCV and anti-HIV antibodies the Abbott (Delkenheim, Germany) IMx system was used. RESULTS: In contrast to the testing for anti-HIV and anti-HCV, the detection of HBsAg (0.125 IU/ml detection limit) was influenced by the presence of anti-HBs in plasma pools. Statistically significant differences could be observed between anti-HBs-positive plasma pools and anti-HBs-negative serum samples spiked with HBsAg. The kinetics of HBsAg-anti-HBs complex formation showed that in a plasma pool with a high anti-HBs (329.4 IU/ml) concentration HBsAg was not detectable after 5 h of incubation. After ICD, HBsAg was still detectable in the pool with high anti-HBs content. Anti-HIV antibodies could be detected up to a dilution of 1/480,000, anti-HCV up to a dilution of 1/80, both in a spiked negative serum. Overall, the divergences between spiked plasma and serum were relatively low for anti-HCV and anti-HIV detection. CONCLUSION: The Abbott IMx assay permits a highly sensitive detection of HBsAg (after ICD or immediately after thawing of anti-HBs-positive plasma pools), anti-HCV, and anti-HIV in plasma pools. However, in case of a contamination with donations originating from individuals with acute HBV, HIV, or HCV infection or with a poor humoral immune response, serologic testing for HBsAg, anti-HIV, and anti-HCV may fail to detect potentially infectious plasma pools.

AIDS Serodiagnosis↗
PubMed1992

Antithrombotic efficacy of low-molecular-weight heparin in deep arterial injury.

Low-molecular-weight heparin subfractions more specifically inhibit factor Xa than thrombin, and they may have advantages over unfractionated heparin in arterial thrombosis. The antithrombotic efficacy of four dosages of a low-molecular-weight heparin (CY216 at 100, 200, 400, or 500 Institute Choay units/kg) was compared with unfractionated calcium heparin (100 US Pharmacopeia units/kg) and placebo during deep arterial injury produced by balloon dilatation of the carotid artery in the pig. The acute thrombotic end points were 111In-labeled platelet and 125I-labeled fibrinogen/fibrin deposition and macroscopic mural thrombosis; these were related to the anti-factor Xa and antithrombin effects of the heparin preparations. Platelet deposition in segments with deep arterial injury was 42 +/- 28, 22 +/- 5, 29 +/- 12, 9 +/- 2, 9 +/- 2, and 11 +/- 3 x 10(6)/cm2 (mean +/- SEM) for pigs treated with placebo, with 100, 200, 400, and 500 units/kg CY216, and with 100 units/kg unfractionated heparin, respectively. Fibrinogen/fibrin deposition was 35 +/- 8, 19 +/- 2, 19 +/- 4, 21 +/- 3, 14 +/- 4, and 12 +/- 3 molecules x 10(12)/cm2, respectively; deposition was significantly reduced in pigs given 100 units/kg unfractionated heparin compared with placebo (p less than 0.05). Mural thrombosis was present in 74%, 45%, 30%, 14%, 5%, and 9% of deeply injured arterial segments, respectively (p = 0.02). Plasma anti-factor Xa activity and prolongation of the activated partial thromboplastin time (aPTT) with 100 units/kg unfractionated heparin were similar to that produced by 200 units/kg and 500 units/kg CY216, respectively. Thus, low-molecular-weight heparin, which predominantly inhibits factor Xa activity, was only moderately effective at reducing platelet thrombus deposition. It was less effective than 100 units/kg unfractionated heparin, except at high dosages, producing similar prolongation of the aPTT and the thrombin time.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed1978

Human skin aryl hydrocarbon hydroxylase. Induction by coal tar.

Coal tar products, which are widely used in treating dermatologic disease, contain numerous polycyclic aromatic hydrocarbons, including 3,4-benzo[a]pyrene (BP). BP is among the most potent environmental chemical carcinogens and is known to evoke tumors in the skin of experimental animals and perhaps also of man. In this study the effect of cutaneous application of coal tar solution (U. S. Pharmacopeia) on aryl hydrocarbon hydroxylase (AHH) activity in the skin of patients usually treated with this drug was investigated. AHH, a cytochrome P-450 dependent carcinogen-metabolizing enzyme appears to play an important role in the activation of polycyclic hydrocarbons into reactive moieties that can bind to DNA and that may directly induce cancer. Application of coal tar solution to human skin caused a two to five-fold induction of cutaneous AHH in nine subjects. In further studies, the incubation of human skin with coal tar solution in vitro also caused variable induction of cutaneous AHH. Maximum responses in both systems occurred after 24 h and enzyme activity in vitro was time- and tissue- and substrate-concentration dependent. Studies in experimental animals showed that topical application of coal tar solution caused induction of AHH in skin and, after percutaneous absorption, in liver as well. Assay of several defined constituents of coal tar for AHH induction showed that BP was the most potent inducer of AHH tested. These studies indicate that topical application of coal tar solution in doses ordinarily used in treating dermatologic disease causes induction of AHH in human skin and suggest that such induced enzymatic activity could relate to carcinogenic responses to this agent in skin or, after percutaneous absorption, in other tissues as well.

Animals↗
PubMed1979

Some effects of the administration of endotoxin in mice. Specific cleavage of serum albumin by an acid protease and the generation of amyloid serum component.

Endotoxin has been shown to induce amyloidosis in mice and to result in the appearance in serum of large amounts of amyloidrelated protein (SAA). After injection of 300 mug lipopolysaccharide Escherichia coli, SAA behaves as an acute phase reactant with levels reaching a peak of >600 mug/ml at 18-22 h and returning to base line (<50 mug/ml) by 48 h in each of four strains tested; only the endotoxin-resistant C3H/HeJ strain showed a smaller response. Lesser, though significant, elevations were also found after subcutaneous injection of 25 mg of casein, bovine serum albumin, ovalbumin, or monomeric immunoglobulin G, whereas pyrogen-free human serum albumin/U. S. Pharmacopeia failed to raise SAA levels. SAA generation may thus be a result of endotoxin contamination of these protein preparations. Also present in equivalent amounts in acidified serum from endotoxin-treated mice, but barely detectable in control sera, was a 3,000-dalton molecule whose amino acid sequence is identical to the amino terminal 24 residues of mouse albumin. The appearance of SAA and the amino terminal albumin fragment after endotoxin were unaffected by pretreatment with cobra venom factor, and equivalent levels were found in C5-deficient mice. Pretreatment with pepstatin in vivo, or before acidification in vitro, prevented the appearance of the albumin fragment but had no effect on the appearance of SAA, whereas leupeptin and antipain did not affect the appearance of either SAA or the albumin fragment. These studies suggest that the generation of SAA after endotoxin administration does not involve complement activation or intravascular proteolytic activity, whereas the liberation of a specific peptic-like cleavage product of albumin appears to be the consequence of an acid protease.

Amino Acid Sequence↗
PubMed1990

L-tryptophan implicated in human eosinophilia-myalgia syndrome causes fasciitis and perimyositis in the Lewis rat.

Tryptophan-associated eosinophilia-myalgia syndrome (L-TRP-EMS) is a newly described syndrome which occurred in epidemic fashion in the United States in the summer and fall of 1989. Epidemiologic data has linked the syndrome to intake of L-tryptophan (L-TRP) from one specific manufacturer, but the precise etiologic compound(s) must be established by replication of the syndrome in an appropriate animal model. In this study, implicated L-TRP, United States Pharmacopeia (USP) grade L-TRP, or vehicle was administered by gavage in a blinded fashion for 38 d to female Lewis rats at doses comparable with those ingested by patients who developed the eosinophilia-myalgia syndrome. Animals receiving implicated L-TRP, but not those receiving USP grade L-TRP or vehicle, developed histologic signs consistent with fasciitis and perimyositis, specific pathologic features of human L-TRP-EMS. Peripheral blood eosinophilia was not observed. Hypothalamic corticotropin releasing hormone mRNA levels were lower and plasma corticosterone levels tended to be lower in the animals that received implicated L-TRP. Plasma L-kynurenine was higher in both L-TRP-treated groups compared to the vehicle-treated animals. The female Lewis rat is known to be susceptible to a wide variety of inflammatory diseases. Identification of specific inflammatory changes in this rat following exposure to implicated L-TRP indicates that this animal model will be important in subsequent investigations into the etiology, pathogenesis, and treatment of human L-TRP-EMS.

Animals↗
PubMed1975

Medical practice without antianxiety drugs.

The benzodiazepines and hydroxyzine were removed from a statewide Medicaid pharmacopeia. Barbiturate sedatives, hypnotic and antipsychotic medication, and tricyclic antidepressants remained available, but no substitution was made for about two-thirds of the deleted ataractic medications. The authors conclide that most physicans regard ataractics as unique and do not use them interchangeably with the other drugs.

Attitude of Health Personnel↗
PubMed2005

Oxymetazoline solutions inhibit middle ear pathogens and are not ototoxic.

OBJECTIVES: This study was performed to explore the antimicrobial activity of two commercially available oxymetazoline hydrochloride preparations against the common pathogens of otitis media and to demonstrate the lack of ototoxicity of these agents and of United States Pharmacopeia (USP) oxymetazoline in a standard animal model. METHODS: Disc diffusion assays and minimum inhibitory concentration studies against American Type Culture Collection reference strains of common middle ear pathogens were used to evaluate the antimicrobial activity of oxymetazoline solutions and fluoroquinolone drops, and outer hair cell counts were performed on scanning electron micrographs of guinea pig basal cochlear segments after chronic exposure to oxymetazoline solutions and positive and negative controls. RESULTS: Oxymetazoline nasal spray and eyedrops had activity against all species tested except Haemophilus influenzae and Pseudomonas aeruginosa. The USP oxymetazoline had limited antimicrobial activity. Oxymetazoline nasal spray, oxymetazoline eyedrops, and USP oxymetazoline had ototoxicity profiles indistinguishable from that of the saline solution control. CONCLUSIONS: Commercially available oxymetazoline solutions are active against several of the common pathogens of otitis media. This antimicrobial activity is not due to oxymetazoline, and is more likely due to preservatives present in the solutions. The solutions tested are not ototoxic to guinea pig outer hair cells. Oxymetazoline solutions are potential substitutes for broad-spectrum antibiotic drops after tympanostomy tube placement.

Adrenergic alpha-Agonists↗
PubMed2006

Lipid injectable emulsions: 2006.

Lipid injectable emulsions are an essential source of fatty acids, as well as a daily source of calories. They have been used in the clinical setting for almost 40 years, but despite this, there are no established official standards governing pharmaceutical quality. After 15 years of development, the United States Pharmacopeia (USP), which writes such standards for all FDA-approved pharmaceuticals, is poised to adopt an official monograph for lipid injectable emulsions that sets pharmaceutical requirements on all manufacturers placing limits on pH, free fatty acid concentrations and globule size (both mean droplet size and the population of large fat globules larger than 5 micrometers). Recent animal data has shown pathophysiologic changes in vital organs for lipids that fall outside the USP-proposed globule size limits. From a clinical perspective, newer lipid injectable emulsions show great promise in certain patient settings, most notably in the intensive care unit in both adults and infants. The clinical use of alternative oils, such as medium-chain triglycerides, fish oil and olive oil show benefits over conventional soybean oil formulations. In adults, for example, the administration of omega-fatty acids via soybean oil-based lipids produces a heightened inflammatory response via production of 2-series prostaglandins, whereas substitution of a portion of the lipid with omega-3 fatty acids via fish oil can favorably dampen the inflammatory response. In infants, for example, substitution of soybean oil with fish oil has recently been shown to reverse parenteral nutrition-associated liver disease. These advances should lead to safer infusion therapy in patients receiving lipid injectable emulsions.

Animals↗
PubMedDate not supplied

Compounding TPN admixtures: then and now.

Compounding TPN admixtures has significantly developed since the first clinical reports by Dr. Dudrick and colleagues from the University of Pennsylvania approximately 35 years ago. Today, the responsibility for the compounding of sage parenteral nutrition admixtures for patients incapable of oral or enteral nutrition primarily rests with the pharmacy department. Although others may influence the desirable components to be contained therin, no one is more qualified to deal with the physicochemical issues and aseptic technique compounding requirements than a registered pharmacist. In fact, the United States Pharmacopeia (USP) , the official drug compendium in the US since 1906, has published Chapter 797 entitled "Pharmaceutical Compounding--Sterile Preparations", enforceable by the FDA, and makes clear the role of the pharmacist in the compounding of safe parenteral admixtures. Ultimately, after careful pharmaceutical review of the final formulation, the composition of the final admixture for infusion will be determined based on the ability to safely compound the prescribed additives in the desired quantities of a specified volume of sterile fluid. There will always be instances, where, for example the patient's needs cannot be safely met through the TPN admixture, primarily because of stability, compatibility and/or sterility issues. When this occurs, suitable alternative methods of delivering the additives in question must be sought so as not to compromise the safety issues of the final TPN infusion. Although there have been many advances in the development of nutritional additives, compounding devices, and containers, significant safety issues continue to arise necessitating further modification of paretneral nutrition protocols. ASPEN, through periodic reviews of tis published guidelines, such as the 1998 Safe Practices for Parenteral Nutrition Formulations, is in a key position to keep nutrition support clinicians abreast of the central issues affecting the safety of TPN therapy.(Journal of Parenteral and Enteral Nutrition

Drug Compounding↗
PubMed1988

Comparative dissolution performance of internationally available piroxicam products.

Piroxicam is a widely used nonsteroidal antiinflammatory drug available worldwide under various trade names by several manufacturers. Only one brand of piroxicam (Feldene) is currently marketed in the U.S., and the United States Pharmacopeial Convention established an official dissolution requirement for piroxicam in 1985. The purpose of this study was to evaluate and compare the dissolution performance of several internationally available piroxicam products using the United States Pharmacopeia (USP) dissolution test for piroxicam capsules. Of 25 brands of piroxicam capsules evaluated, 72 percent of the brands failed to meet the USP requirement, several by a wide margin. Although there is no specific USP dissolution test for tablets, the test for capsules was applied to five different brands of piroxicam tablets, and 80 percent of the tablet brands tested failed to meet the USP requirement. Although comparative bioavailability studies would be required to establish any definitive relationship between dissolution test performance and bioavailability, the failure of most of these products to meet the USP requirement for dissolution indicates formulation differences that could result in altered bioavailability. The substantial differences in dissolution performance observed among the piroxicam oral dosage forms tested have implications concerning the equivalency and standards of multisource products available on the international market, and should be taken into account by health care providers worldwide.

Biological Availability↗
PubMedDate not supplied

Development of a questionnaire for detecting potential adverse drug reactions.

OBJECTIVE: To develop a comprehensive list of symptoms categorized by body system as part of a questionnaire for detecting potential adverse drug reactions. DATA SOURCES: A preliminary list of symptoms in lay terminology was extracted from the "Side Effects" section of all drug monographs contained in the United States Pharmacopeia Dispensing Information (USP DI) computerized database (Volume II, Advice for the Patient) using natural language processing software. The list was sorted alphabetically and duplicate terms were eliminated. Symptoms were then categorized by body system or anatomic region. A preferred term for each symptom was selected when multiple synonyms and related words were listed. Finally, all of the symptom terms were incorporated into a thesaurus from which the questionnaire was derived. RESULTS: The questionnaire will be used as part of a computer-assisted interview, developed to solicit information from patients regarding their medication regimens and to systematically query them regarding the presence of salient symptoms or complaints. The computer system will eventually interface with the USP DI database to identify drugs from a patient's regimen that may be associated with adverse symptoms. The symptom thesaurus will provide the link to the USP DI database. Preliminary experience with the questionnaire in a limited number of patients has been encouraging. CONCLUSIONS: The questionnaire can assist clinicians in identifying drug-related symptoms including unreported adverse clinical effects of newly marketed or investigational therapeutic agents. When the questionnaire is computerized and linked to a comprehensive database, it can be more widely used to alert healthcare providers of potential adverse drug reactions that may otherwise go undetected.

Adverse Drug Reaction Reporting Systems↗
PubMed1993

Comparative studies on the in vitro drug dissolution profiles for hydroxyzine hydrochloride tablets.

OBJECTIVE: A significant practical problem in the standardization of dissolution testing is addressed. In vitro releasing characteristics of hydroxyzine hydrochloride tablets are presented to further the documentation of bioequivalency criteria. DESIGN: The assessment model compares the official United States Pharmacopeia disintegration approach for dissolution analysis with that of the Food and Drug Administration's recommended rotating paddle technique for inducing aqueous disruption of the solid oral dosage form. RESULTS: The rationale and significance of the study focuses attention on the variation in release of the active ingredient observed relative to the four formulation strengths. With differences in the extent of dissolution noted and official standards in mind, emphasis is placed on the development of an alternate test protocol. CONCLUSIONS: Dissolution data derived via ultraviolet spectrophotometry revealed statistically significant differences in the amount of hydroxyzine hydrochloride being released from its coated structure, the extent of which was found to be dependent on the acid nature of the simulated gastric dissolution medium used and intensity of mixing action employed.

Hydroxyzine↗