Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “PHARMACOPEIA”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 631 records · Page 35Linked to original sources
PubMed1995

A new bioassay for insulin in conscious rabbits by continuous measurement of glycemic responses.

Because of the substantial variability often observed in the determination of insulin potency by the United States Pharmacopeia (USP) bioassay method, a large number of rabbits are required in order to attain an accuracy of +/- 6% and each bioassay needs 2-3 weeks to be completed. In this report, an improved bioassay method has been developed. This bioassay was conducted in conscious healthy rabbits. The decline in blood glucose levels, following intravenous injection of an insulin preparation, was monitored (in uninterrupted manner) by the continuous glucose monitoring system developed. A glucose response curve was generated, and from this response curve, various pharmacodynamic parameters were easily determined. The whole procedure could be completed in 1 day and also achieved an accuracy where upon only one rabbit is needed to determine accurately the insulin potency. To validate the method, a total of nine healthy rabbits were studied to determine the inter- and intra-animal reproducibility. The values of insulin potency determined from four pharmacodynamic parameters were compared, and the potency calculated from the ABGC (area of the blood glucose response curve under baseline) was found to be the most accurate: a mean (+/- SEM) value of 102.3(+/- 1.2)% was determined by inter-animal study (n = 9) and a value of 100.6(+/- 1.3)% by intra-animal study (n = 4). The inter-bioassay variability among the random-dose bioassays was 1.2% for inter-animal and 1.3% for intra-animal studies. The insulin potency in an insulin sample determined by this bioassay had attained an overall mean (+/- SEM) value of 101.6(+/- 0.8)% (n = 17).(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed2005

Micellar electrokinetic chromatography for simultaneous determination of six corticosteroids in commercial pharmaceuticals.

We have developed a micellar electrokinetic chromatography (MEKC) method using bile salts for the simultaneous determination of six corticosteroids, including betamethasone, cortisone, prednisolone, 6alpha-methylprednisolone, triamcinolone, and prednisone. The separation was performed using borate buffer containing sodium cholate and sodium deoxycholate. Several parameters were studied, including bile salt concentrations, concentrations and pH of borate buffer, and analytical voltages. In method validation, calibration curves were linear over a range of 10-100 microM for each corticosteroid. The RSD (relative standard deviation) and RE (relative error) were all less than 5% for intra- and interday assays. The limit of detection of each analyte was 5 microM. The recoveries were greater than 95%. Application of this method for quality control of commercial tablets also proved to be feasible. All analytical values fall within the labeled amount of 90-110% for betamethasone and prednisolone, and of the labeled amount of 92.5-107.5% for 6alpha-methylprednisolone, as required by the United State Pharmacopeia 25 (USP 25).

Adrenal Cortex Hormones↗
PubMedDate not supplied

Quantitative analysis of flavonol glycosides in Ginkgo biloba: a comparison of two analytical methods.

A comparison of testing methods for constituents of Ginkgo biloba was performed as part of the process for determining which of the many available analytical methods was most appropriate for inclusion in the American Herbal Pharmacopoeia (AHP). Three primary methods were reviewed: those adopted by the European Pharmacopoeia, the National Science Foundation-Institute for Nutraceutical Advancement (NSF-INA) and the United States Pharmacopeia. Methods were compared by evaluating sample preparation and hydrolysis, precision and methods of total flavonol glycoside calculation by two independent laboratories. The AHP adopted the method of NSF-INA for inclusion in the AHP monograph owing to observed superiority of this method in terms of precision, glycoside calculation, ease of sample preparation and chromatographic parameters.

Chromatography, High Pressure Liquid↗
PubMed1997

A new WHO International Reference Reagent for use in potency assays of inactivated poliomyelitis vaccine.

Assays of the potency of inactivated poliovirus vaccine require the use of an appropriate reference reagent. Preparation 91/574 was shown by international collaborative study to be suitable for determination of antigenic content and immunogenicity of inactivated poliovirus vaccines by in vitro and in vivo assays, respectively. The reagent is a trivalent blend of formaldehyde-inactivated monovalent pools of poliovirus type 1 (Mahoney) poliovirus type 2 (MEF-1) and poliovirus type 3 (Saukett). Studies by antigen-capture ELISA showed that the component monovalent pools contained high titres of D antigen and trace amounts of C antigen. Sucrose gradient analysis showed that the D antigenicity was almost exclusively associated with 150S virus particles. Low levels of procapsids (75S particles with D antigenicity) were detected in the type 1 and 2 monovalent pools. The profile of intact virions and procapsids in 91/574 in sucrose gradients was very similar to PU78-02, a previously used inactivated trivalent poliovirus vaccine reference. The World Health Organization (WHO) Expert Committee on Biological Standardization at its 1994 meeting established preparation 91/574 as the 2nd WHO international Reference Reagent for poliomyelitis vaccine (inactivated). A potency of 430, 95, 285 D antigen units per ml was assigned to poliovirus type 1, 2 and 3, respectively. A separate aliquot of this preparation, established by the European Pharmacopeia Commission as a Biological Reference Preparation, has an identical assigned titre. The 2nd WHO International Reference Reagent 91/574 is intended for calibration of secondary reference reagents.

Animals↗
PubMed2000

Anti-HIV activity of extracts and compounds from algae and cyanobacteria.

The human immunodeficiency virus (HIV) is the retrovirus that causes the acquired immune deficiency disease syndrome (AIDS). This review discusses the anti-HIV activity of extracts and compounds isolated from freshwater and marine algae, and cyanobacteria (formerly called "blue-green algae"). Compounds and extracts with anti-HIV activity are also active against other retroviruses such as herpes simplex virus (HSV), but the amount of antiviral activity varies with the compound and the virus. Most of the research has focused on sulfated homopolysaccharides and heteropolysaccharides. Sulfoglycolipids, carrageenans, fucoidan, sesquiterpene hydroquinones, and other classes of compounds with anti-HIV activity that have been isolated from algae have received less attention. Most studies have used in vitro test systems, but a few in vivo studies have been carried out using compounds isolated from algae or analogs produced synthetically or isolated from other natural sources. Sulfated homopolysaccharides are more potent than sulfated heteropolysaccharides. The presence of the sulfate group is necessary for anti-HIV activity, and potency increases with the degree of sulfation. Studies using nonsulfated and sulfated homo- and heteropolysaccharides isolated from algae or other natural sources, or synthesized, have revealed the mechanisms of binding of drugs to the virion, and the mechanisms of viral binding to host cells. However, given the few classes of compounds investigated, most of the pharmacopeia of compounds in algae and cyanobacteria with antiretroviral activity is probably not known.

Animals↗
PubMed1996

Purity determinations in the bulk drug of the novel indoloquinone antitumor agent EO9.

The pharmaceutical development of the investigational cytotoxic drug EO9 included the structural characterization of the bulk drug by nuclear magnetic resonance (NMR) spectroscopy, mass spectrometry (MS) and infrared (IR) spectroscopy, and analytical characterization by high-performance liquid chromatography and ultraviolet/visible spectrophotometry. The presence of impurities in the bulk drug was investigated. The intermediates in the synthesis of EO9 were structurally characterized by NMR spectroscopy and MS, and analytically characterized by HPLC analysis with photodiode array (PDA) detection. All of the intermediates were below their limits of detection in EO9 bulk drug. The amounts of residual organic solvents were determined by gas chromatography. Methanol and ethanol were detected, but the amounts present did not exceed the limits as set in the United States Pharmacopeia XXII.

Antineoplastic Agents↗
PubMed1976

Comparative evaluation of 99mTc-generators.

A total of 34 99mTc-generators from eight different manufactures were studied in 1974 and 1975 with regard to their performance and to the quality of the eluates. With some exceptions the generators performed well and proved their ability to act as a reliable source of 99mTc-pertechnetate. Two cases of mechanical malfunction and two cases with a low elution yield of 99mTc were observed. Four generators were overloaded with 99Mo. The 99mTc-pertechnetate did in most cases fulfil the requirements of the Nordic Pharmacopeia.

Chemical Industry↗
PubMed1984

Lindane binding to sections of human skin: skin capacity and isotherm determinations.

Human autopsy skin was sliced into three sections; an outer epidermis-rich layer, a middle dermis layer, and an inner dermis and subcutaneous fat layer. Each slice was bathed in lindane solutions over a 50-fold concentration range for 48 h at 37 degrees C. Lindane uptake by the skin was extensive (less than 90%) for all concentrations and all skin slices. Equilibrium dialysis with lindane at 37 degrees C for 24 h showed binding affinities by the skin sections to exceed 98%. The binding constants of the outer skin section (epidermis-rich) were higher than those of the middle and inner sections. The binding attraction for lindane by United States Pharmacopeia (USP) human plasma protein fraction (mean 90.5% bound) resulted in its competitive extraction from the skin slices in a three-compartment dialytic procedure. Since the least binding constants were in the middle and inner layers, and since lindane has a preference for plasma over skin, the two (inner skin and plasma) may combine to create the sink conditions necessary for lindane percutaneous absorption into the body. This plus the high epidermis capacity for lindane explains why in some instances (such as occlusion) high levels of lindane can be percutaneously absorbed.

Biological Transport, Active↗
PubMed1986

Chemical, radiochemical, and radionuclide purity of eluates from different commercial fission 99Mo/99mTc generators.

Seven 99Mo/99mTc generators (using fission 99Mo) obtained from seven different manufacturers were studied in 1984 and 1985 to test the quality of the eluates. We present the findings concerning the elution efficiency, radionuclide purity, 99Mo breakthrough, radiochemical purity, pH, and aluminium content of the eluates. One generator was overloaded with 99Mo by about 40%, while one generator had 99mTc yields of only about 80%. The eluates generally (although with some exceptions) exhibited a high and satisfactory radionuclidic purity and good radiochemical purity. The low-level determination of 99Mo breakthrough using a commercially available dose calibrator with a 99Mo assay shield indicated a misleadingly high 99Mo content. All of the eluates had pH values of between 5.0 and 5.5, and the aluminium content was always below the detection limit of 1 microgram per milliliter of eluate. The generators performed well and proved their capability of functioning as reliable sources of sodium pertechnetate Tc99m. In all cases, the pertechnetate produced met the requirements of the European Pharmacopeia.

Quality Control↗
PubMed1995

An impedimetric method for rapid screening of cosmetic preservatives.

An efficient impedance method was developed for rapid evaluation of cosmetic preservatives. The method used decimal reduction time or D-value to assess preservative efficacies. The D-value, which was calculated from the plot of Log CFU ml-1 versus time by linear regression analysis, could be obtained within 48 h. Thus, the time required for the challenge test was reduced from 4-8 weeks with the standard procedures (eg US Pharmacopeia), to 2 days with the current method. A calibration curve (r = -0.95) was established by plotting the Log CFU ml-1 versus capacitance detection time (DT) of 108 samples. With the calibration, CFU can be estimated directly from the impedance test without plating. Two commercial biocides and several other chemicals were evaluated in a shampoo by the impedance procedure against Pseudomonas aeruginosa. The D-values obtained from the impedance test were not significantly different from those produced by the conventional plate count method. The technique was found to be particularly useful when screening a large number of compounds to find novel preservatives and synergistic preservative combinations.

Cosmetics↗
PubMedDate not supplied

Comparison of Prenate Advance with other prescription prenatal vitamins: a folic acid dissolution study.

Folic acid is important in the prevention of neural tube defects. This study assessed the folic acid dissolution performance of Prenate Advance and six other commonly prescribed prenatal vitamins and compared the results with the United States Pharmacopeia (USP) standards. Of the seven products tested, only three met the USP standard for folic acid dissolution. At 110% of the labeled amount, the Prenate Advance product had the highest folic acid dissolution level. Average dissolution for the four products failing to meet the USP standard ranged from 0% to 38% of labeled amount. These results corroborate findings from other studies suggesting marked differences in dissolution of prescription prenatal vitamins. These findings raise concerns of whether some women could fail to achieve the recommended folate levels needed in early pregnancy to prevent neural tube defects. Prenate Advance met the USP requirement for folic acid dissolution.

Biological Availability↗
PubMed2006

A favourable benefit/risk ratio with efalizumab: a review of the clinical evidence.

Moderate to severe plaque psoriasis has traditionally been treated with agents that have toxicities associated with long-term use. Many patients therefore cannot be treated safely, conveniently or effectively with traditional therapies. Recent phase 3 clinical trials for efalizumab, a biological agent targeted specifically at the T-cell-based pathology of psoriasis, have demonstrated its short- and long-term efficacy and safety for the treatment of psoriasis. This article reviews results from 12-week, six-month, and three-year trials, focusing on the drug's safety, efficacy, and therapeutic response time, as well as the phenomenon of rebound in non-responding patients. Efalizumab emerges as an important addition to the dermatological pharmacopeia for the long-term treatment of psoriasis.

Antibodies, Monoclonal↗
PubMed2005

Oral dosage form performance tests: new dissolution approaches.

The performance test is one of a series of tests that compose the specification in a United States Pharmacopeia (USP) dosage form monograph. For an orally administered, nonsolution dosage form, it is usually satisfied by either a dissolution or disintegration procedure. Dissolution acceptance criteria are usually set in private negotiations between an applicant and a regulatory agency. With information about this private agreement and other information provided in a sponsor's Request for Revision to USP, the USP's Council of Experts elaborates a public dosage form monograph. Based on the relationship between the regulatory decisions and the Request for Revision, the USP dissolution procedure links to a regulatory judgment about bioavailability and bioequivalence and, ultimately, to a judgment about safety and efficacy. The current dissolution procedure and acceptance criteria are perceived as having worked well over the years and are generally accepted. This article discusses new approaches that merit consideration. These approaches focus on a) explicit use of hypothesis testing, b) use of parametric tolerance intervals, c) improved ways to set dissolution acceptance criteria, and d) a more flexible protocol to assess conformity. Application of the proposed approaches may better assess, manage, and communicate both manufacturer and consumer risk for dissolution testing.

Administration, Oral↗
PubMed2005

Usefulness of the USP Medication Counselling Behavior Guidelines.

OBJECTIVE: To assess the perceived usefulness of the United States Pharmacopeia (USP) Medication Counselling Behavior Guidelines among Finnish community pharmacists. The Guidelines were systematically disseminated to pharmacists through a 4-year project (TIPPA 2000-2003). METHOD: A postal questionnaire was sent to a random sample (n = 734) of Finnish community pharmacists (response rate 51%). RESULTS: More than one quarter (27%) of the respondents was aware of the Guidelines. The Guidelines were made known to the respondents mostly via a book on patient counselling skills (41% of those knowing the Guidelines), continuing education (37%), and in-house training (28%). Over 60% of those who knew about the Guidelines regarded them as a good or very good instrument for learning the principles of patient counselling. The Guidelines were considered less useful as an instrument for the self-evaluation of performance in different settings. CONCLUSION: The results of this study indicate that even though the USP Guidelines have been promoted strongly through basic and continuing education during the TIPPA Project, more than half of the respondents were not aware of the Guidelines. The Guidelines were considered more useful in learning the principles of patient counselling than learning self-evaluation of performance.

Adult↗
PubMed1992

Adenosine and its cardiovascular effects.

Adenosine is a new antiarrhythmic agent recently released with the permission of the Food and Drug Administration. It is an endogenously occurring nucleoside indicated for use in the diagnosis and treatment of supraventricular tachycardia. Its greatest utility is in patients with AV nodal reentry. Its antiarrhythmic action is mediated at the cellular level through the potassium channel, causing hyperpolarization of the myocyte membrane potential. In addition to its current indication as an antiarrhythmic agent, adenosine is now being used under an investigational protocol for pharmacologic stress testing. It can be given in conjunction with thallium or used in echocardiography as an imaging tool for patients who can not be adequately exercised. Adenosine's side effect profile is relatively benign and the agent's extremely short half-life makes most adverse reactions clinically insignificant. In this report we attempt to highlight this agent's clinical utility and discuss its future in the cardiovascular pharmacopeia.

Adenosine↗
PubMed1996

Talc pleurodesis: talc slurry versus thoracoscopic talc insufflation in a porcine model.

BACKGROUND: Pleurodesis using both talc slurry and thoracoscopic talc insufflation has been shown to be clinically effective. This study compares these two modalities of pleural talc instillation in an animal model. METHODS: Eleven immature pigs underwent general endotracheal anesthesia. On one side, a slurry of 5 g sterile United States Pharmacopeia talc in 50 mL of saline solution was instilled through a thoracostomy tube. On the other side, the lung was deflated and 5 g of dry talc was insufflated under thoracoscopic visualization. The animals were sacrificed 30 days later, and the quality of pleural adhesions was graded from 0 to 2 (0 = absent; 1 = light; 2 = dense) in each of six regions of each hemithorax. The distribution of adhesions on each side was graded from 0 to 6, according to the number of areas that contained adhesions. RESULTS: One animal died of anesthetic complications. Among the survivors, adhesions produced by both methods were dense and diffuse in 8 of 10 animals, and light and diffuse in 1 animal. One animal had light or absent adhesions on the talc slurry side, and dense and diffuse adhesions on the thoracoscopic talc insufflation side. There was no difference between the techniques for density of adhesion scores (talc slurry, 9.9 +/- 2.2; thoracoscopic talc insufflation, 10.0 +/- 2.5) or distribution of adhesion scores (talc slurry, 5.5 +/- 1.0; thoracoscopic talc insufflation, 5.8 +/- 0.4) (p > 0.1). CONCLUSIONS: Effective pleurodesis in a porcine model can be obtained with either talc slurry or thoracoscopic talc insufflation.

Animals↗
PubMed1995

Heparin versus normal saline as a peripheral line flush in maintenance of intermittent intravenous lines in obstetric patients.

OBJECTIVE: To compare heparin sodium (100 United States Pharmacopeia U/mL) with 0.9% sodium chloride for use in the maintenance of intermittent intravenous (IV) devices during pregnancy. METHODS: Women at 26-34 weeks' gestation who required serial phlebotomy were assigned randomly to heparin or normal saline flush, administered in a double-blind fashion. Catheter sites were examined and flushed with the study solution at least once every 6 hours. Partial thromboplastin times (PTTs) were measured at catheter insertion and 48 hours later. Statistical analysis was performed with Student t test, Mann-Whitney U test, Fisher exact test, log-rank, and X2 analysis, as appropriate. RESULTS: There was a significant increase in catheter patency rate at 48 and 72 hours in the heparin group (26 of 31 versus 17 of 33, and 21 of 31 versus nine of 33, respectively; P < .01). In addition, there was a significantly lower rate of catheter complications in the heparin group (four of 31 versus 13 of 33; P < .01). There were no differences in PTTs. CONCLUSION: During pregnancy, dilute heparin flush to maintain patency of intermittent IV site devices results in the following: a greater catheter patency rate at 48 and 72 hours after insertion of the catheter, a lower rate of catheter complications requiring therapy, and no alteration in PTT.

Adult↗
PubMedDate not supplied

Systemic drug interactions with topical glaucoma medications.

Topically administered ophthalmic medications are capable of attaining clinically important serum concentrations, as evidenced by the variety of systemic side effects they can produce. These drugs are therefore also capable of interacting with other drugs administered orally and intravenously. This is especially important when medications are administered to an elderly population, who are often receiving multiple medications. The Physician's Desk Reference and the United States Pharmacopeia Drug Information directory contain numerous warnings of potential interactions between topical glaucoma medications and systemically administered drugs. Unfortunately, literature supporting such interactions is limited, both in quantity and quality, being anecdotal in many cases. This report summarizes available information regarding the nonocular interactions between topical ophthalmic glaucoma medications and other systemically administered medications. Clinical evidence of these interactions is lacking in many cases.

Administration, Topical↗