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PubMed2005

The Jerusalem Balsam: from the Franciscan Monastery in the old city of Jerusalem to Martindale 33.

The Jerusalem Balsam, a remedy based on an ethanolic extract of a herbal mixture, was formulated in 1719 in the pharmacy of the Saint Savior monastery in the old city of Jerusalem. Having gained fame, the Jerusalem Balsam was replicated and prepared in Europe. One can still find variations of the formula in current pharmacopoeias (B.P., 1998. The Stationary Office, London, p. 1510; Sweetman, S.C., Blake, P.S., McGlashan, J.M., Parsons, A.V., 2002. Martindale: The Extra Pharmacopeia, 33rd ed. Pharmaceutical Press, London, p. 1101). We report here, five different formulas, all referred to as "The Jerusalem Balsam". Three of those formulas were translated and two of these translations are presented in the text. A third one is available as Supplementary data online. As the formulas originate from different historical periods, the Jerusalem Balsam may be a good case study of the development of pharmaceutical formulations over a 250 years period. One of the formulas, found in a manuscript form in the archive of the monastery, contains four plants: olibanum (Boswellia spp.), myrrh (Commiphora spp.), aloe (Aloe sp.) and mastic (Pistacia lentiscus L.). We conducted pharmacological assays on this four-plant formula. It showed anti-inflammatory, as well as anti-oxidative, and anti-septic properties.

Animals↗
PubMed2004

Validation of a generic analytical procedure for determination of residual solvents in drug substances.

A generic analytical procedure for determination of residual solvents in drug substances is described and validated. The procedure is based on methods described in the European and United States parmacopeias, but is faster than the compendial procedures. It is applicable both during drug development and for quality control in commercial manufacture. The method is accurate, linear and shows a satisfactory level of precision. The solvents included in the validation comprise the five class 1 solvents, 17 out of 27 class 2 solvents, 17 out of 27 class 3 solvents and three unclassified solvents according to ICH guideline Q3C. The solvents can be detected and quantified at levels at or below the ppm limits given in the guideline. In most cases the quantification limit is in the lower ppm range. A strategy is proposed to choose between water or N,N-dimethyl formamide as a diluent. The need for re-validation of the method, mandatory for quantitative procedures according to the European Pharmacopeia, is minimised when using the generic procedure.

Calibration↗
PubMed2005

Official USP Reference Standards: metrology concepts, overview, and scientific issues and opportunities.

The United States Pharmacopeia (USP) is a private standards-setting body created in 1820 by practitioners who wished to promote the quality of therapeutic products in commerce. The principal product of USP, then and now, is the United StatesPharmacopeia (USP), to which was added the National Formulary (NF) in 1975. The two compendia are published as a combined text annually (USP-NF). Originally a book of process standards, USP-NF evolved over time into compendia containing primarily product standards that are expressed in monographs for therapeutic ingredients, products, and excipients. As a public health service, USP supplies official USP Reference Standards to manufacturers and others who wish to test an article according to selected procedures of a monograph or General Chapter. During the past decade, understanding of USP monographs and official USP Reference Standards as a means of controlling the quality of a therapeutic article has evolved, based on advances in metrology, on activities in the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), and on considerations by the USP Council of Experts and its Expert Committees and USP staff. This article discusses the evolution of this understanding, focusing on drug substances and excipients for well-characterized small molecules and their corresponding dosage forms.

Adverse Drug Reaction Reporting Systems↗
PubMed2005

Determination of tobramycin and impurities using high-performance anion exchange chromatography with integrated pulsed amperometric detection.

Tobramycin is one of a class of aminoglycoside antibiotics that lack a good chromophore, and is therefore difficult to determine using reversed-phase HPLC with absorbance detection. This is especially true for determining the quantity of each impurity. We show that tobramycin and its major impurities, including kanamycin B and neamine (neomycin A), can be separated on a strong anion-exchange column using a weak potassium hydroxide eluent (2.00 mM) at a column temperature of 30 degrees C, and directly detected by integrated pulsed amperometric detection (IPAD). The resolution (United States Pharmacopeia (USP) definition) between tobramycin and kanamycin B ranged from 5.71 and 6.06 over 7 days of consecutive analysis (5.92+/-0.07, n = 590 injections). Due to the difficulty of producing weak hydroxide eluents of the required purity (i.e. carbonate-free), this method depends on automatic eluent generation to ensure method ruggedness. This method exhibited good long-term (50 days, 2368 injections) retention time stability with R.S.D.s of 0.4% and 0.3% for tobramycin and kanamycin B, respectively. Peak area R.S.D.s for tobramycin and kanamycin B (10 microM each, 20 microL injection) over 7 days (572 injections) were 2.3% and 1.9%, respectively. Method robustness was evaluated by intentionally varying the flow rate, eluent concentration, column temperature, and column. Based on the results of these evaluations, this method can be used for tobramycin identity, assay, and purity.

Anion Exchange Resins↗
PubMed2006

Determination of neomycin sulfate and impurities using high-performance anion-exchange chromatography with integrated pulsed amperometric detection.

Neomycin B is one of a class of aminoglycoside antibiotics that lack a good chromophore, and is therefore difficult to determine using reversed-phase HPLC with absorbance detection. This is especially true for determining the quantity of each impurity. We show that neomycin sulfate and its major impurities, including neamine (neomycin A), can be separated on a strong anion-exchange column using a weak potassium hydroxide eluent (2.40 mM) at a column temperature of 30 degrees C, and directly detected by integrated pulsed amperometric detection (IPAD). The resolution (United States Pharmacopeia (USP) definition) between neomycin B and the closest major impurity ranged from 6.56 and 7.45 over 10 days of consecutive analysis (7.24+/-0.10, n=836 injections). Due to the difficulty of producing weak hydroxide eluents of the required purity (i.e. carbonate-free), this method depends on automatic eluent generation to ensure method ruggedness. This method exhibited good long-term (10 days, 822 injections) retention time stability with a R.S.D. of 0.6%. Peak area R.S.D. (10 microM) was 1.3%. Method robustness was evaluated by intentionally varying the flow rate, eluent concentration, column temperature, and column. The spike recoveries of neomycin B from extractions of three different topical ointments and cream formulations ranged from 95 to 100%. The measured concentration of neomycin B in these formulations ranged from 119 to 154% of the label concentration. The R.S.D. for the measured concentration of one of the formulations tested over three separate days, n=11 extracts, was 3.2%. Based on the results of these evaluations, we believe this method can be used for neomycin sulfate identity, assay, and purity.

Aminoglycosides↗
PubMed2006

Simultaneous determination of streptomycin and oxytetracycline in agricultural antimicrobials by CZE after an experimental design.

A capillary zone electrophoresis (CZE) method was developed and validated for the simultaneous determination of both streptomycin (STP) and oxytetracycline (OTC) in bactericidal products to be used in agriculture. Using fused-silica capillaries, the influence of the electrolyte composition, pH and concentration, as well as temperature and applied voltage were investigated using a central composite design to optimize the method. The optimized electrophoretic conditions were as follows: 0.10 M sodium phosphate, pH 2.5, 7.0 kV and 20.0 degrees C. The method was validated for STP and OTC determination in agricultural formulations through the following performance criteria: linearity and linear range, sensitivity, selectivity, intra-day and inter-day precision, detectability, accuracy and ruggedness. This optimized CZE-method for the identification and quantification of STP and OTC is a potential alternative method to the HPLC methods described by the US Pharmacopeia, with the advantage that the same method could be used for the simultaneous determination of these different antibiotics.

Agrochemicals↗
PubMedDate not supplied

A rational regulatory approach for positron emission tomography imaging probes: from "first in man" to NDA approval and reimbursement.

We propose a new regulatory approach for positron emission tomography (PET) molecular imaging probes, essential tools in today's medicine. Even though the focus of this paper is on positron-emitting labeled probes, it is also justified to extend this proposed regulatory approach to other diagnostic nuclear medicine radiopharmaceuticals. Key aspects of this proposal include: (1) PET molecular imaging probes would be placed in a "no significant risk" category, similar to that category for devices in current Food and Drug Administration (FDA) regulations, based on overwhelming scientific evidence that demonstrates their faultless safety profile; (2) the FDA-sanctioned Radioactive Drug Research Committee (RDRC) will oversee all diagnostic research with these probes. The newly defined RDRC should approve "first in man" use; supervise a broader spectrum of diagnostic research protocols, including those looking to demonstrate initial efficacy, as well as multicenter clinical trials and the use of molecular imaging probes as a screening tool in drug discovery. The current investigational new drug (IND) mechanism is thus eliminated for these diagnostic probes; (3) when a molecular imaging probe has demonstrated diagnostic efficacy, FDA approval (i.e., NDA) will be sought. The review will be done by a newly constituted Radioactive Drug Advisory Committee (RDAC) composed of experts chosen by the professional societies, who would provide a binding assessment of the adequacy of the safety and efficacy data. When the RDAC recommends its diagnostic use on scientific and medical grounds, the molecular imaging probe becomes FDA approved. After a molecular imaging probe is approved for a diagnostic indication, the existing mechanism to seek reimbursement will be utilized; and (4) the FDA would retain its direct oversight function for traditional manufacturers engaged in commercial distribution of the approved diagnostic molecular imaging probes (i.e., under NDA) to monitor compliance with existing US Pharmacopeia (USP) requirements. With abbreviated and more appropriate regulations, new PET molecular imaging probes for diagnostic use would be then rapidly incorporated into the mainstream diagnostic medicine. Equally importantly, this approach would facilitate the use of molecular imaging in drug discovery and development, which would substantially reduce the costs and time required to bring new therapeutic drugs to market.

Animals↗
PubMed2004

Do pictograms improve children's understanding of medicine leaflet information?

There is a growing need for balanced drug information customized for special target groups such as children [Food and Drug Administration. Prescription Drug Product Labeling; Medication Guide Requirements; Proposed Rule. Part VII. Department of Health and Human Services, 21 CRF Part 201, et al. Federal Register 1995;60:44182-252; Dickinson D, Raynor DK, Duman M. Patient information leaflets for medicines: using consumer testing to determine the most effective design. Patient Educ Couns 2001;43:147-59]. Pictograms are one aid that may be used to make information easier to read and understand. The aim of this study was to test whether children understand pictograms developed by the United States Pharmacopeia (USP) [The United States Pharmacopeial Convention Inc. USP Pictograms. Retrieved 11 March 2002 from http://www.usp.org/], and especially, if the pictograms improve children's understanding of medicine leaflet information. Finnish elementary school children aged 7 years (n=28), 11 years (n=31) and 13 years (n=31) were interviewed and asked what they thought 15 USP pictograms mean. The two older age groups were also asked to read an "easy-to-read" leaflet for penicillin-V. Every second child was given a leaflet with a plain text and the others received the same text accompanied by pictograms. After reading the leaflet, the children were asked seven questions related to the text. Most of the children understood the meanings of the selected 15 pictograms correctly, the proportion of the correct explanations varying from 30 to 99% according to the pictogram. Even well-understood pictograms did not help the children understand the leaflet information, although they reduced the need for probing. This study shows that the context in which pictograms are tested makes a difference in the results. Testing plain pictograms without incorporating them in their real context, e.g., in the patient information leaflet may exaggerate their usefulness in leaflet information.

Adolescent↗
PubMedDate not supplied

Out-of-hospital medication storage temperatures: a review of the literature and directions for the future.

The United States Pharmacopeia (USP) National Formulary prescribes the packaging, storage, and distribution of medications. Most of the medications commonly used by emergency medical services (EMS) are intended for storage at "controlled room temperature." The USP definition of controlled room temperature is multifaceted and complex, and cannot be easily described as a simple range of acceptable temperatures, or even as an average temperature. The out-of-hospital environment is notoriously uncontrolled, and one of the uncontrolled aspects of that environment is temperature. This report reviews and summarizes the past 15 years of published research relating to out-of-hospital medication temperature exposures. Although the evidence is clear that EMS medication storage is not consistent with the USP definition of controlled room temperature, the impact of EMS medication storage on medication stability and potency remains unclear. Further research is needed to determine the true extent of the EMS medication storage problem, and to develop and validate appropriate solutions.

Drug Stability↗
PubMedDate not supplied

Characteristics of medication errors made by students during the administration phase: a descriptive study.

Faculty concentrate on teaching nursing students about safe medication administration practices and on challenging them to develop skills for calculating drug dose and intravenous flow rate problems. In spite of these efforts, students make medication errors and little is known about the attributes of these errors. Therefore, this descriptive, retrospective, secondary analysis study examined the characteristics of medication errors made by nursing students during the administration phase of the medication use process as reported to the MEDMARX, a database operated by the United States Pharmacopeia through the Patient Safety Program. Fewer than 3% of 1,305 student-made medication errors occurring in the administration process resulted in patient harm. Most were omission errors, followed by errors of giving the wrong dose (amount) of a drug. The most prevalent cause of the errors was students' performance deficits, whereas inexperience and distractions were leading contributing factors. The antimicrobial therapeutic class of drugs and the 10 subcategories within this class were the most commonly reported medications involved. Insulin was the highest-frequency single medication reported. Overall, this study shows that students' administration errors may be more frequent than suspected. Faculty might consider curriculum revisions that incorporate medication use safety throughout each course in nursing major courses.

Adverse Drug Reaction Reporting Systems↗
PubMed2005

Comparison of potentially hepatotoxic drugs among major US drug compendia.

BACKGROUND: Although a large number of drugs include warnings or listed adverse reactions that describe reports of associated hepatotoxicity, the hepatotoxic risk is documented with different definitions in major drug compendia. OBJECTIVES: The purposes of this study were to compare inclusion of potentially hepatotoxic drugs, and analyze the ratings of hepatotoxic risk among major drug compendia. METHODS: To assess the risk of drug-associated hepatotoxicity, we used current literature of epidemiological studies and developed a 4-level rating scale of hepatotoxic drugs: 3, clear literature evidence of life-threatening hepatotoxicity; 2, multiple case reports or significant liver injuries; 1, no significant liver damage has been reported; and 0, no information. All drugs were evaluated using the 5 major US drug compendia: American Hospital Formulary Service (AHFS), United States Pharmacopeia Drug Information (USPDI), Facts and Comparisons (F&C), Physicians' Desk Reference (PDR), and Clinical Pharmacology (CP). Average rating scores were calculated as the sum of each drug rating score divided by the total number of drugs. One-way analysis of variance and independent t tests were conducted to compare the difference among the rating scores. RESULTS: In total, 175 different drugs and 3 therapeutic classes with hepatotoxic effects were identified in the compendia, including 59 antineoplastics, 28 anti-infectives, 17 nonsteroidal anti-inflammatory drugs, 17 antipsychotics or phenothiazine derivatives, 9 angiotensin-converting enzyme inhibitors, 6 anticonvulsants, 4 histamine-2 receptor antagonists, and other drugs. Average rating scores were 1.65 for AHFS, 1.10 for USPDI, 1.27 for F&C, 1.34 for PDR, and 1.61 for CP (F=7.93, P<.0001). The risk categories were significantly different among compendia in 4 therapeutic classes of antipsychotics and/or phenothiazines (F=3.471, P=.011), nonsteroidal anti-inflammatory drugs (F=7.866, P<.0001), antineoplastics (F=2.476, P=.044), anti-infectives (F=2.003, P=.098), and angiotensin-converting enzyme inhibitors (F=38.125, P<.0001). CONCLUSIONS: Rating scores of hepatotoxicity were significantly different among drug compendia. The different compendium put different emphasis on hepatotoxicity severity. Comprehensive evaluations of hepatotoxic-related drugs provide critical information for health practitioners.

Chemical and Drug Induced Liver Injury↗
PubMed2006

Comparative study of the quality and efficacy of originator and generic albendazole for mass treatment of soil-transmitted nematode infections in Nepal.

The quality and efficacy of two locally manufactured generic albendazole (ABZ) products (Curex and Royal Drug) used for deworming children in Nepal since 1999 were tested against the originator product (GlaxoSmithKline (GSK)). The study included disintegration and dissolution testing according to the Indian Pharmacopoeia (IP) and the United States Pharmacopeia (USP), respectively, as well as a randomised controlled clinical trial comparing cure rates (CR) and egg reduction rates (ERR) for Ascaris lumbricoides, Trichuris trichiura and hookworm infections. Stool samples from 1277 children were examined before and 21 days after treatment. For A. lumbricoides, GSK (97.0%) and Royal Drug (95.0%) ABZ achieved significantly higher CRs than Curex ABZ (82.6%); however, all products achieved ERRs >90%. For T. trichiura, Curex ABZ showed significantly lower ERRs (63.2%). For hookworms, GSK ABZ performed significantly better (CR 74.3%, ERR 87.1%) than Royal Drug ABZ (CR 53.3%, ERR 80.8%) and Curex ABZ (CR 50.7%, ERR 73.1%). Only the GSK product passed both disintegration and dissolution tests according to the IP and USP. Both generic products failed the dissolution tests. Curex ABZ showed poor disintegration. Despite its lower efficacy, the cheaper Curex product achieved good results in controlling morbidity due to soil-transmitted helminth infections. This study shows that the cost effectiveness of drugs used in mass deworming campaigns should not be inferred on the basis of a single quality testing parameter.

Adolescent↗
PubMed2003

Medication errors in the OR--a secondary analysis of Medmarx.

Although medication errors can result in serious patient complications or even death, a paucity of information regarding medication errors that occur in the OR exists. AORN and the US Pharmacopeia (USP) collaboratively conducted a secondary analysis of reports of medication errors that occurred in the OR. These reports were submitted to the USP via the Medmarx program. The findings will give perioperative clinicians further insight into the types and causes of medication errors that occur in the OR and will help them develop potential prevention strategies.

Databases, Factual↗
PubMed1996

Radiopharmaceutical regulation and Food and Drug Administration policy.

The regulatory policy of the Food and Drug Administration (FDA) on radiopharmaceuticals flows from a rigid, traditional, drug-like interpretation of the FDC Act on the licensing of radiopharmaceuticals. This contributes to significant delays in the drug-approval process for radiopharmaceuticals, which are very costly to the nuclear medicine community and the American public. It seems that radiopharmaceuticals would be better characterized as molecular devices. Good generic rule-making principles include: use of a risk/benefit/cost analysis; intent based on sound science; performance standards prepared by outside experts; a definite need shown by the regulatory agency; to live with the consequences of any erroneous cost estimates; and design individual credential requirements so that additional training results in enhanced professional responsibility. When these common elements are applied to current FDA policy, it seems that the agency is out of sync with the stated goals for revitalizing federal regulatory policies as deemed necessary by the Clinton administration. Recent FDA rulings on positron-emission tomography, Patient Package inserts, and on medical device service accentuate the degree of such asynchronization. Radiopharmaceutical review and licensing flexibility could be dramatically improved by excluding radiopharmaceuticals from the drug category and reviewing them as separate entities. This new category would take into account their excellent record of safety and their lack of pharmacological action. Additionally, their evaluation of efficacy should be based on their ability to provide useful scintiphotos, data, or responses of the physiological system it portends to image, quantitate, or describe. To accomplish the goal of transforming the FDA's rigid, prescriptive policy into a streamlined flexible performance-based policy, the Council on Radionuclides and Radiopharmaceuticals proposal has been presented. In addition, it is suggested that the United States Pharmacopeia write radiopharmaceutical review standards, that an independent scientific body review the data submitted, and that the FDA either accept or reject the recommendation.

Humans↗
PubMed1987

Hypoglycemia: how little is too much for the embryo?

The effects of hypoglycemia on mammalian embryos undergoing neurulation (third to fourth week of human development) were investigated. Mouse embryos were maintained for 28 hours in whole embryo culture in serum collected from rats that had received 50 units of 100 United States Pharmacopeia insulin units per milliliter. Glucose concentrations used were 40, 60, 80, and 147 mg/dl (normal blood glucose in the pregnant mouse is 125 mg/dl). After the culture period embryos were evaluated for malformations and growth and compared with those maintained under euglycemic conditions. The results demonstrate that glucose concentrations approximately 50% of normal maternal levels were teratogenic but not growth inhibitory, whereas concentrations in the range of 30% to 40% of maternal levels were lethal to the embryo. Furthermore, a 14-hour exposure to reduced blood sugar in either the first or second half of the culture period produced malformations.

Animals↗
PubMed1998

Medication errors analysis is an opportunity to improve practice.

The United States Pharmacopeia (USP) Medication Errors Reporting (MER) Program collected and cataloged 2,213 reports between October 1991 and November 1996. Medication errors occur in all health care facilities, involve health care practitioners from all disciplines, and involve drugs from all categories, including neuromuscular blocking agents (38 out of 2,213). This class of drugs is discussed as an example of the program, and we trust will serve the reader as an educational guide about medication errors that occur with drugs in any class. When used inappropriately, they represent a higher morbidity and mortality than many other drug classes analyzed. Reports indicate various causes for the errors, such as similar-appearing products, and include suggestions by practitioners to prevent recurrence of the error. The USP Advisory Panel on Medication Errors has developed recommendations for facilities that are intended to prevent errors with neuromuscular blocking agents (NMB). The USP Medication Errors Reporting Program is presented in cooperation with the Institute for Safe Medication Practices (ISMP).

Adverse Drug Reaction Reporting Systems↗
PubMed2006

[Quality control of hospital preparations: results concerning capsules production in a child hospital].

In France, lack of paediatric drugs leads pharmacies to produce many hospital preparations in order to meet prescribers'needs. To ensure the quality of these preparations, the pharmacy department of the Armand Trousseau Child Hospital set up a quality control system of its capsules. It integrates both European Pharmacopeia's requirements (Mass and Content uniformity test) and more strict internal quality specifications. They include exactitude of the average content compared to the awaited content, coefficient of variation of the contents and, "modified" content uniformity test. These criteria and the percentage of nonconformity are used as indicators to assure quality follow-up of the preparations. We reviewed quality control records for five hospital preparations produced over the last three years. We highlighted that lower dosage showed a higher percentage of nonconformity compared to higher dosage. Type of active ingredients was a key factors too (1,0% and 14.8% of non conform batches for ursodesoxycholic acid and for morphine hydrochloride respectively). Analysis showed that the essential character of content test because mass test is not predictive of the conformity of the batch. Content test was the main criterion to judge batches conformity. Thus, it will be generalized to all our preparations. These study results helped us to implement new procedures to assure an ongoing improvement of our practices of preparation.

Capsules↗
PubMed2000

Capillary electrophoresis analysis of gentamicin sulphate with UV detection after pre-capillary derivatization with 1,2-phthalic dicarboxaldehyde and mercaptoacetic acid.

A selective, sensitive, and rapid pre-capillary derivatization method for determination of the multicomponent aminoglycoside antibiotic gentamicin is described. The derivatization reagents 1,2-phthalic dicarboxaldehyde and mercaptoacetic acid were used and the thioisoindole derivative was UV detected at 330 nm. A central composite experimental design was performed to optimize selectivity and derivatization conditions. Baseline separation of gentamicin C1, C1a, C2, C2a, C2b, sisomicin and several minor components was achieved with a background electrolyte containing 30 mM sodium tetraborate, 7.5 mM beta-cyclodextrin and 12.5% (v/v) methanol at pH 10. Quantitative analysis was performed and illustrated the potential use of capillary electrophoresis for the identification and quantitation of gentamicin as an alternative to methods prescribed in the United States Pharmacopeia and European Pharmacopoeia.

Electrophoresis, Capillary↗