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PubMed1998

Prevalence of adverse reactions to positron emitting radiopharmaceuticals in nuclear medicine. Pharmacopeia Committee of the Society of Nuclear Medicine.

UNLABELLED: This study was undertaken to determine the prevalence of adverse reactions to positron emitting radiopharmaceuticals as well as to nonradioactive drugs used in interventional nuclear medicine during PET studies. METHODS: A prospective 4-yr study was performed with 22 collaborating institutions using a questionnaire, which indicated for each month of the study the number of PET procedures performed, the number of adverse reactions to PET radiopharmaceuticals as well as the number of adverse reactions to interventional nonradioactive pharmaceuticals used for PET. RESULTS: A total of 33,925 radiopharmaceutical doses were recorded in a retrospective examination of records by the 22 participating institutions. In addition, the total prospective number of administered doses recorded by the participants was 47,876, for a total number of positron emitting radiopharmaceutical administrations of 81,801. No adverse reactions were found from any PET radiopharmaceutical dose. There were no deaths or hospitalizations caused by nonradioactive interventional pharmaceuticals used adjunctive to PET studies. CONCLUSION: PET radiopharmaceuticals have an extraordinary safety record with no adverse reactions reported in over 80,000 administered doses in this study.

Humans↗
PubMed1975

[General methods and specifications].

The reasons are explained why general methods are described in pharmacopeias. With the help of examples taken from European Pharmacopeias, the United States Pharmacopeia, and the International Pharmacopeia, the author reports the general chemical and physical methods that were used in compiling these pharmacopeias. The description of these general methods, and particularly of the instruments, goes often beyond the actual bounds of a pharmacopeia and may fulfill a didactic function. The methods used in the various pharmacopeias, especially the chemical ones, are here compared and subjected to the author's critical analysis. The author explains also that technical progress in the analytical field should not be hampered by the rigidity of the pharmacopeia's rules; this can be easily avoided by resorting to alternate methods.

Chemistry, Pharmaceutical↗
PubMed2002

[The plant origins of herbal medicines and their quality evaluation].

The caulis (stem and leaf) of Trachelospermum jasminoides (Lindl.) Lem. (Apocynaceae) is listed as the plant origin of Luoshiteng in the Chinese Pharmacopeia. However, preparations from the caulis of Ficus pumila L. (Moraceae) or Psychotria serpens L. (Rubiaceae) are distributed on the Chinese market. The fruit of Forsythia suspensa Vahl (Oleaceae) is listed as the plant origin of Forsythia Fruit in the Chinese Pharmacopeia, although the fruits of two Forsythia species, F. suspensa and F. viridissima Lindley, are listed as the plant origins in the Japanese Pharmacopeia, and fruits of three Forsythia species, F. viridissima, F. koreana Nakai, and F. suspensa, are listed in the Korean Pharmacopeia. The whole plant of Plantago asiatica L. (Plantaginaceae) is listed as the plant origin of Plantago Herb in the Japanese Phamacopeia, but the whole plants of two Plantago species, P. asiatica and P. depressa Wild, are listed as the plant origins in the Chinese Pharmacopeia. The leaves of two Plantago species, P. lanceolata L. and P. major L., are distributed as Plantain on the European market. Each of these herbal medicines is reviewed based on the differences in plant origins and their quality evaluation from the viewpoints of the morphological properties, chemical components, and biological activities, respectively.

Animals↗
PubMed2002

[Comparison among families of Mutong].

OBJECTIVE: To distinguish families of Mutong correctly and direct effective and safe clinical administration. METHOD: Comparison among families of Mutong on Herbs, Taxology, Clinic, Pharmacology and Toxicology. RESULT: 1. There are mainly three families of Mutong: Lardizabalaceae, Ranunculaceae, Aristolochiaceae, which were all included in China Pharmacopeia in 1963. However only Mutong of Ranunculaceae and Aristolochiaceae family have been included in China Pharmacopeia since 1977, but Mutong of Lardizabalaceae family has not been included in China Pharmacopeia ever since. 2. It was Mutong of Lardizabalaceae family that was used mainly through the ages without toxic records, and Mutong of Aristolochiaceae e.g. Caulis Aristolochia manshuriensis (CAM) was not put down in writing of past ages but is mainly used today with toxicity repeatedly. 3. CAM contain aristolochic acid and aristololactam with high toxicity, which plays an uncertain role in diuresis with poor bactericidal power. Mutong of Lardizabalaceae family e.g. Akebia trifoliata (Thunb.) Koidz. var. australis (Diels) Rehd (ATKV) don't contain aristolochic acid and aristololactam, which has low toxicity and plays a certain role in diuresis with high bactericidal power. CONCLUSION: It may be quite safe to use ATKV instead of CAM in clinics. So we suggest that ATKV should be reused as first Mutong in China Pharmacopeia revised edition in order to ensure a correct understanding of the facts and reveal Mutong in its true colors, and CAM should be used as second Mutong strictly according to the rules in China Pharmacopeia revised edition.

Animals↗
PubMed1994

Ability of laboratory methods to predict in-use efficacy of antimicrobial preservatives in an experimental cosmetic.

The abilities of nine antimicrobial systems to preserve an experimental water-based cosmetic formulation were evaluated by six microbiological challenge tests: the U.S. Pharmacopeia test; the British Pharmacopeia test; the Cosmetic, Toiletry, and Fragrance Association test; the rapid screen test; the sequential challenge test; and the post-use test. The antimicrobial systems contained various combinations and amounts of two parabens and a quaternary compound in order to provide a broad range of preservation. The results obtained were compared with the abilities of the formulations to support maintenance and growth of microorganisms in microfloras obtained from human axilla areas and finger skin during an 8-week simulated in-use test. Without statistical analysis all of the tests predicted the results obtained with well-preserved or poorly preserved formulations. The rapid screen test was the best test for predicting differences at intermediate levels of preservation. Statistically, all of the tests were equivalent predictors of preservation efficacy in the in-use test (P = 0.05). At the P = 0.10 level, only the U.S. Pharmacopeia, British Pharmacopeia, rapid screen, Cosmetic, Toiletry, and Fragrance Association tests were significantly predictive. The results of prediction by a test, based on the preservative levels used, agreed well with the in-use test results (P = 0.01). A total of 20% of the formulations that contained excessive microbial levels contained human axilla microorganisms. The levels of preservation in failed products were similar to the levels of preservation in unused controls.

Axilla↗
PubMed1998

Do different heparin brands influence activated clotting times?

A change in brand suppliers of heparin at our institution resulted in a number of anecdotal reports of possible differences in potency. Both products are marketed as heparin sodium extracted from porcine intestinal mucosa. Heparin Leo is 1000 international units (British Pharmacopeia) per ml. while Hepalean is 10,000 United States Pharmacopeia (U.S.P) units per ml. Perfusion records were retrospectively reviewed for one month periods when Heparin Leo (n = 52) or Hepalean (n = 61) were used to provide anticoagulation therapy for cardiopulmonary bypass. Heparin Leo was found to be less clinically potent than Hepalean. While increasing the initial loading dose of Heparin Leo by 5% (378 vs 398 units/kg-1), the initial post load activated clotting time (ACT) was 17% lower (556 vs 666 seconds). Heparin units required per kilogram per minute of cardiopulmonary bypass were 23% higher for Heparin Leo. Additionally 8 of 52 Heparin Leo patients did not achieve an initial post load ACT of greater than 400 secs while this occurred in 2 of 61 patients treated with Hepalean. These results were statistically significant. British Pharmacopeia and United States Pharmacopeia heparin reference standards differences are insufficient to explain the discrepancies observed in this study.

Animals↗
PubMed2000

Ultra-high throughput screen of two-million-member combinatorial compound collection in a miniaturized, 1536-well assay format.

Results of a complete survey of the more than 2-million-member Pharmacopeia compound collection in a 1536-well microvolume screening assay format are reported. A complete technology platform, enabling the performance of ultra-high throughput screening in a miniaturized 1536-well assay format, has been assembled and utilized. The platform consists of tools for performing microvolume assays, including assay plates, liquid handlers, optical imagers, and data management software. A fluorogenic screening assay for inhibition of a protease enzyme target was designed and developed using this platform. The assay was used to perform a survey screen of the Pharmacopeia compound collection for active inhibitors of the target enzyme. The results from the survey demonstrate the successful implementation of the ultra-high throughout platform for routine screening purposes. Performance of the assay in the miniaturized format is equivalent to that of a standard 96-well assay, showing the same dependence on kinetic parameters and ability to measure enzyme inhibition. The survey screen identified an active class of compounds within the Pharmacopeia compound collection. These results were confirmed using a standard 96-well assay.

Chemistry, Pharmaceutical↗
PubMed1975

[Role and functions of the European Pharmacopoeia].

Following an agreement between the Common Market on one side and the Partial Agreement of the Council of Europe on the other, it was decided in Rome in April 1963 to compile gradually a Pharmacopeia to be called "European", which would be mandatory in Germany, Belgium, France, Italy, Luxembourg, the Netherlands and the United Kingdom. Switzerland joined the group in 1964. A Commission entrusted with full powers was created: each country is represented on it by a three-member delegation. It started its work in 1964, with prof. Marini-Bettolo as president. The work of the Commission was planned by approximately 150 experts, subdivided into about 15 groups of specialists in the various fields. The first volume was published in 1969, the second in 1971, followed by a supplement in 1973; the third volume was supposed to appear in April 1975 with another supplement planned for the end of 1975. The collection of these volumes will represent the first edition of the European Pharmacopeia and will consist of about 1,500 pages; half of these will cover general rules and the rest will include about 320 monographs. With the addition of Denmark and Ireland, which joined the Common Market at a later date, the European Pharmacopeia will be in force in an area with a population of 260 million. Any country belonging to the Council of Europe is entitled to join the Convention and several countries have already expressed the desire to do so.

Europe↗
PubMed2002

Computation of the physio-chemical properties and data mining of large molecular collections.

Very large data sets of molecules screened against a broad range of targets have become available due to the advent of combinatorial chemistry. This information has led to the realization that ADME (absorption, distribution, metabolism, and excretion) and toxicity issues are important to consider prior to library synthesis. Furthermore, these large data sets provide a unique and important source of information regarding what types of molecular shapes may interact with specific receptor or target classes. Thus, the requirement for rapid and accurate data mining tools became paramount. To address these issues Pharmacopeia, Inc. formed a computational research group, The Center for Informatics and Drug Discovery (CIDD).* In this review we cover the work done by this group to address both in silico ADME modeling and data mining issues faced by Pharmacopeia because of the availability of a large and diverse collection (over 6 million discrete compounds) of drug-like molecules. In particular, in the data mining arena we discuss rapid docking tools and how we employ them, and we describe a novel data mining tool based on a ID representation of a molecule followed by a molecular sequence alignment step. For the ADME area we discuss the development and application of absorption, blood-brain barrier (BBB) and solubility models. Finally, we summarize the impact the tools and approaches might have on the drug discovery process.

Algorithms↗
PubMed1996

3(3) factorial design-based optimization of the formulation of nitrofurantoin microcapsules.

A microcapsule form of nitrofurantoin was prepared by a simple coacervation method with carboxymethylcellulose and aluminium sulfate. 3(3) factorial design was performed for three independent variables, namely, the particle size of the drug, the size of the microcapsules and the pH of the dissolution medium. The dissolution tests with the formulated microcapsules were carried out according to the United States Pharmacopeia XXII rotating basket method at pH 1.2, 5, and 7.5, which represent the pH of gastrointestinal fluids. Release data were examined kinetically and the ideal kinetic models were estimated and t(63.2) values obtained from RRSBW distribution were used in the factorial design experiment. The influence of the independent variables on the dissolution of nitrofurantoin microcapsules could be expressed as the pH of the dissolution medium > particle size of the microcapsule > particle size of nitrofurantoin. The other aim of this study was to evaluate microcapsule formulation in terms of the United States Pharmacopeia criteria with a minimum of experiments. Our findings suggest that dosage forms which comply with the pharmacopoeia criteria for dissolution can be prepared and selected by factorial design.

Alum Compounds↗
PubMed2006

Lipid injectable emulsions: Pharmacopeial and safety issues.

Lipid injectable emulsions have been routinely used in patients worldwide for over 40 years as a nutritional supplement in patients requiring parenteral nutrition. They can be given as a separate infusion or added into total parenteral nutrition admixtures. Despite such broad use, no pharmacopeial standards exist with respect to the optimal pharmaceutical characteristics of the formulation. Several attempts to establish standard physical and chemical attributes have been attempted by various pharmacopeias around the world, but without success largely due to technical issues regarding the creation of globule size limits. Recently, the United States Pharmacopeia has revised its previous efforts and developed two methods and criteria (under Chapter <729>) to measure the mean droplet size (Method I), and the large-diameter tail > 5 mum (Method II) of the globule size distribution to verify the stability of lipid injectable emulsions. Importantly, it is the latter size limits of Method II that have the greatest implications for infusion safety. The major safety issues involving lipid injectable emulsions include impairments in plasma clearance in susceptible patients, and the infusion of an unstable emulsion containing large quantities of potentially embolic fat globules. Recent animal studies investigating the toxicity from the infusion of unstable lipid injectable emulsions have shown evidence of oxidative stress and tissue damage to the liver when recommended globule size limits determined by Method II of the USP are exceeded. Adoption of Chapter <729> of the USP seems appropriate at this time.

Animals↗
PubMed1996

Evaluation of liquid chromatography methods for the separation of ampicillin and its related substances.

Two laboratories collaborated to examine the selectivity of four isocratic liquid chromatography (LC) methods for the separation of ampicillin and its related substances. The United States Pharmacopeia (USP) assay method gave the best selectivity. Similar selectivity was obtained on C18 columns as well as on C8 and poly(styrene-divinylbenzene) copolymer columns. A resolution test using cefradine was proposed to replace the test with caffeine prescribed by the USP. Based on the USP method, a gradient LC method was developed for the analysis of related substances in ampicillin. This LC method has been proposed for assay and purity control in the ampicillin monographs of the European Pharmacopeia.

Ampicillin↗
PubMed2006

Can stock rotation effectively mitigate EMS medication exposure to excessive heat and cold?

The United States Pharmacopeia recently published a general chapter specifically addressing on-ambulance storage of medications, including a suggestion for stock rotation. This study describes the effectiveness of a simple stock rotation strategy in mitigating EMS medication exposure to excessive heat and cold. Previously collected on-ambulance temperature data from 5 US cities were randomly resampled to generate model exposures of 2 days to 6 months duration. The temperature measurements for every other 24-hour period were then set at 20 degrees C to model the rotation of medications into a controlled environment. For each model, we then determined consistency with the official United States Pharmacopeia definition of controlled room temperature. Without stock rotation, excessive heat occurred in 39.9% of the model exposures. With stock rotation, exposures to excessive heat occurred in less than 1% of northern city models and in 2.9% of the central US models. Stock rotation did not reduce heat exposures in the models for southern cities.

Ambulances↗
PubMed2000

A rapid LC method for the identification and determination of CNS drugs in pharmaceutical formulations.

Antidepressant, neuroleptic and antiepileptic drugs were identified and determined in pharmaceutical formulations (tablets, capsules and oral solutions) by a rapid high-performance liquid chromatography method. The sample pretreatment consisted of a one-step extraction, filtration and dilution. The chromatographic conditions were: reversed-phase C8 column (150 x 4.6 mm i.d., 5 microm); acetonitrile-tetramethylammonium perchlorate aqueous solution (pH 2.8; 12.6 mM) (45:55, v/v) as the mobile phase; detection wavelength, 230 nm. Calibration curves were linear in the 100-1000 ng ml(-1) range for all tested drugs except for phenobarbital. The repeatability (or intra-day precision), expressed by the relative standard deviation, was better than 2.0%. The accuracy, resulting from recovery studies, was between 98.1 and 101.3%. The amount of drug found agreed with the declared content within the limits specified by United States Pharmacopeia and British Pharmacopeia.

Calibration↗
PubMed1990

The development of USP dissolution and drug release standards.

Dissolution tests have been in use in the pharmaceutical industry for over 20 years, and they are official in The United States Pharmacopeia since the early 1960s. The dissolution test, reviewed primarily as a quality control tool, replaced the use of disintegration tests which had been official in The United States Pharmacopeia since 1950. Refinements in the dissolution test equipment and methodology have occurred over the years in order to enhance its relevance. The Subcommittees of the USP Committee of Revision dealing with these issues have developed and refined compendial dissolution standards and policies for conventional solid-oral dosage forms and modified-release dosage forms.

Delayed-Action Preparations↗
PubMed2003

Stability and microbiology of inhalant N-acetylcysteine used as an intravenous solution for the treatment of acetaminophen poisoning.

STUDY OBJECTIVE: Intravenous N-acetylcysteine has been used as an antidote for acetaminophen poisoning for more than 25 years in Europe and Canada. In the United States, only the oral administration of N-acetylcysteine is approved by the US Food and Drug Administration. Many physicians routinely use the inhalant preparation as an intravenous formulation; however, no stability, microbiology, or pyrogen studies have been performed. In this study, we evaluate the stability and microbiology of inhalational N-acetylcysteine compounded as an intravenous formulation. METHODS: A total of 8 N-acetylcysteine solutions (solution A through H) were prepared by injecting 150 mL of 20% solution through a 22-microm filter to 1 L of 5% dextrose (D(5)W; 2.6% solution). Solutions A through C were prepared at ambient conditions (25 degrees C [77 degrees F], 65% relative humidity), and solution D was prepared at accelerated conditions (40 degrees C [104 degrees F], 75% relative humidity) for stability testing. The assays were performed by means of high-performance liquid chromatography at 0, 4, 8, 12, 24, 36, 48, 60, and 72 hours according to US Pharmacopeia XXIV methodology. Solutions E through G were assessed for bacterial growth, and solution H underwent pyrogen testing by using a Limulus amebocyte lysate method. RESULTS: Solutions A through C remained stable for at least 60 hours (<10% decomposition), but at 72 hours, there was a 10.3%, 14.9%, and 13.4% degradation, respectively. Under accelerated conditions (solution D), stability lasted for more than 72 hours. Solutions E through G remained free from bacterial growth at 72 hours, and solution H tested negative for endotoxins-pyrogens. CONCLUSION: Inhalational N-acetylcysteine prepared as an intravenous solution meets US Pharmacopeia standards for stability up to 60 hours and is free from bacteria and their byproducts, offering a viable alternative to the traditional use of oral N-acetylcysteine.

Acetaminophen↗
PubMed2007

Parametric two-stage sequential quality assurance test of dose content uniformity.

The United States Pharmacopeia (USP) content uniformity sampling acceptance plan consisting of a two-stage sampling plan with criteria on sample mean and number of out-of-range tablets is the standard for compendium. It is, however, often used mistakenly for lot quality assurance. In comparison to the Japan Phamacopeia (JP) procedure, USP procedure is less discriminative between lots with on-target mean and small variance and lots with off-target mean and large variance. The new European Pharmacopeia (EP) and USP harmonized test adopted a tolerance interval approach. But the "no-difference zone" criteria modification for off-target products make the approaches biased in favor of off-target products. We propose a parametric tolerance interval procedure to test a two-sided specification that is equivalent to the test of two one-sided hypotheses. Testing against a lower specification is to assure that the drug product is not under-dosed for the sake of efficacy. On the other hand, testing against an upper specification is to assure that the drug product is not over-dosed for the sake of safety. The operating curves of the proposed procedure are compared with those of the USP test to illustrate the difference in acceptance probability against the mean and variance of the lot.

Algorithms↗
PubMed1993

Development and validation of a polymerase chain reaction method for the precise quantitation of HIV-1 DNA in blood cells from subjects undergoing a 1-year immunotherapeutic treatment.

OBJECTIVE: To validate a quantitative polymerase chain reaction method developed to measure HIV-1 DNA in peripheral blood mononuclear cells. DESIGN: The assay was used to measure HIV-1 DNA in 15 consecutive blood samples taken from subjects enrolled in a multicenter, randomly allocated, double-blind, placebo-controlled trial using an HIV-1 immunogen. The assay was validated following the United States Pharmacopeia guidelines. The analytical parameters assessed were sensitivity, specificity, linearity and precision. METHODS: The quantitative analysis was obtained by (1) co-amplifying HIV-1 DNA targets with an endogenous control (globin); (2) extrapolating the target values using HIV-1 and globin standard curves; and (3) normalizing the HIV-1 copy numbers to the globin copy numbers (genomic DNA load). RESULTS: With United States Pharmacopeia assay validation methodology, the HIV-1 DNA polymerase chain reaction assay proved to be sensitive, specific, linear and precise and the evaluation of the relative difference between two consecutive blood samples was reproducible. The intra-assay variability, which examines the reproducibility of replicates, was determined using a conservative assessment (tolerance intervals). We established that an increase of 60% or more in the number of DNA copies or a decrease of 38% or more was significantly greater than the variation due to random or experimental error and therefore attributed this variability to a significant change in the HIV-1 DNA copy number. CONCLUSION: We developed and validated a polymerase chain reaction method for the precise quantitation of HIV-1 DNA in peripheral blood mononuclear cells. This assay was able to detect changes in viral loads in HIV-1-infected asymptomatic subjects enrolled in a double-blind placebo-controlled trial using an HIV-1 immunogen.

Biomarkers↗