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PubMed2001

Commercially available ocular hypotensive products: preservative concentration, stability, storage, and in-life utilization.

PURPOSE: With the recent addition of several new ocular hypotensive agents to the pharmacopeia, glaucomatologists have more choices in selection of pharmacotherapy. Several of these new agents have special storage requirements or a limited shelf-life when stored under certain conditions. METHODS: To better inform physicians and patients about pharmaceutical issues relating to the correct usage or storage of ophthalmic products used to manage glaucoma, the authors reviewed the US Food and Drug Administration requirements for sterile ophthalmic preparations, together with the United States Pharmacopeia 24. They also reviewed the Ophthalmic Physicians Desk Reference (2000 edition) for pharmaceutical information regarding branded glaucoma-solution products. RESULTS: The US Food and Drug Administration requires that both analytical tests (e.g., concentration of preservative) and functional tests (e.g., preservative efficacy tests) be undertaken to show the sterility of liquid products. In addition, extensive chemical testing of the potency and stability of the active molecule and other physicochemical properties of the formulation are needed to justify expiration dates and determine the shelf-life of the product. Of the 19 products that met the search criteria, 17 (89%) used benzalkonium chloride as the primary preservative agent, in weight-to-volume ratios ranging from 0.004% (Betagan, Optipranolol) to 0.020% (Xalatan). Five products had a warning against freezing, and 12 required protection from light. Only one product required refrigerated storage before opening, though most products specify an upper range for temperature exposure during storage. CONCLUSIONS: Physicians and their patients need to be aware of the special requirements of each product to assure that they receive the dose of medication as prescribed. The distinction between stability during storage before dispensing (shelf-life) and the acceptable "in-use life" after opening of the dispensed product are essential for the safe and efficacious management of glaucoma.

Antihypertensive Agents↗
PubMed2005

Stability and compatibility assessment techniques for total parenteral nutrition admixtures: setting the bar according to pharmacopeial standards.

PURPOSE OF REVIEW: The stability and compatibility of total parenteral nutrition mixtures compounded for patients requiring nutritional support is paramount to their safety on intravenous infusion. The most significant pharmaceutical issues associated with mixing total parenteral nutrition formulations affecting their safety involve the stability of lipid-injectable emulsions and the compatibility of calcium and phosphate salts. Methods of analysis for stability and compatibility have varied, and the assessments have mostly been largely qualitative. RECENT FINDINGS: Although pharmacopeial standards have been primarily applicable to pharmaceutical manufacturers, recent efforts by the United States Pharmacopeia have been directed at standardizing pharmacy practices involved in the safe mixing of compounded sterile preparations. The adoption of chapter 797 entitled 'Pharmaceutical compounding - sterile preparations' on 1 January 2004 has had a dramatic impact on pharmacy practice in the United States. More recently, the United States Pharmacopeia has also proposed a new chapter 729 entitled 'Globule size distribution in lipid-injectable emulsions', setting specific limits on the sizes and concentrations of lipid droplets in the formulation, which may have implications for all-in-one mixtures. Finally, new efforts are under way to establish limits on the level of acceptable amounts of particulates intrinsically introduced by the manufacturer, and thus may have ramifications for particulates extrinsically introduced or initiated during compounding by the pharmacist. SUMMARY: With careful monitoring and the development of appropriate pharmacopeial-based specifications that limit the size and concentration of large-diameter fat globules and eliminate the possibility of dibasic calcium phosphate precipitates, improved patient outcomes may be achieved.

Drug Compounding↗
PubMed1988

Comparative study between liquid and solid media for the detection of bacterial contamination in intravenous solutions.

For the sterility testing of intravenous solutions, the Pharmacopeia recommend the use of liquid media. However, contamination by a single micro-organism during the test may lead to the inappropriate blocking of the release of the batch. An alternative method using solid media for culturing the membranes used in the filtration was therefore sought. With an artificial contamination with 10-100 colony-forming-units (cfu) of nine different micro-organisms, including those advocated by the Pharmacopeia, the feasibility of two different methods was assessed using two different intravenous solutions manufactured in our hospital. The results show that recoveries of minute amounts of bacteria using solid media and liquid media were similar. In all experiments there was a concordance in both positive and negative results. However, the batches of solutions have to be tested as quickly as possible after their preparation, whatever the method used, to avoid false-negative tests.

Bacteria↗
PubMed1985

Dialysate sodium control during modeling in hemodialysis.

Dialysate sodium (Na+) modeling in hemodialysis requires precise individual adjustment and control of Na+ dialysate concentration. In practice, variations of Na+ concentration can be important and can affect the accuracy of Na+ modeling. Variations relate mainly to the low accuracy of dialysate concentrate (+/- 2.5% for Na+ is tolerated by the European Pharmacopeias), purity of hemodialysis water (2.17 mEq/L is the limit fixed by the French Pharmacopeia), and precision of the proportioning delivery systems for hemodialysis bath preparation. To minimize these difficulties, this study focused on the following points: (a) Na+ concentration is maintained constant (133 mEq/L) in the dialysate manufacturing unit. In 1982, 268 dialysate preparations (177,000 L) were made, and the mean value for Na+ concentration was 133.1 +/- 0.3 mEq/L with a probability of 99.9%. (b) The purity of the water, especially for Na+, Ca2+, and K+, is controlled for two times a day. (c) The accuracy of the proportioning delivery system is controlled by two conductivity monitors, and the variation of Na+ concentration around 133 mEq/L is smaller than +/- 0.5%. As the composition of the basic dialyzing fluid remains constant before adaptation, conductivity values reflect exactly Na+ variation, and are not affected by variations of other elements (K+, Ca2+, Mg2+) that may occur when modification of the dialysate is used for Na+ modeling. (d) Na+ dialysate concentration is adapted for each patient's need by a bedside monitor with sterile Na+ solutions (5 mol/L).(ABSTRACT TRUNCATED AT 250 WORDS)

Humans↗
PubMed2006

Use and perceived benefits of handheld computer-based clinical references.

OBJECTIVE: Clinicians are increasingly using handheld computers (HC) during patient care. We sought to assess the role of HC-based clinical reference software in medical practice by conducting a survey and assessing actual usage behavior. DESIGN: During a 2-week period in February 2005, 3600 users of a HC-based clinical reference application were asked by e-mail to complete a survey and permit analysis of their usage patterns. The software includes a pharmacopeia, an infectious disease reference, a medical diagnostic and therapeutic reference and transmits medical alerts and other notifications during HC synchronizations. Software usage data were captured during HC synchronization for the 4 weeks prior to survey completion. MEASUREMENTS: Survey responses and software usage data. RESULTS: The survey response rate was 42% (n = 1501). Physicians reported using the clinical reference software for a mean of 4 years and 39% reported using the software during more than half of patient encounters. Physicians who synchronized their HC during the data collection period (n = 1249; 83%) used the pharmacopeia for unique drug lookups a mean of 6.3 times per day (SD 12.4). The majority of users (61%) believed that in the prior 4 weeks, use of the clinical reference prevented adverse drug events or medication errors 3 or more times. Physicians also believed that alerts and other notifications improved patient care if they were public health warnings (e.g. about influenza), new immunization guidelines or drug alert warnings (e.g. rofecoxib withdrawal). CONCLUSION: Current adopters of HC-based medical references use these tools frequently, and found them to improve patient care and be valuable in learning of recent alerts and warnings.

Adult↗
PubMed2005

Equivalence studies for complex active ingredients and dosage forms.

This article examines the United States Pharmacopeia (USP) and its role in assessing the equivalence and inequivalence of biological and biotechnological drug substances and products-a role USP has played since its founding in 1820. A public monograph in the United States Pharmacopeia-National Formulary helps practitioners and other interested parties understand how an article's strength, quality, and purity should be controlled. Such a monograph is a standard to which all manufactured ingredients and products should conform, and it is a starting point for subsequent-entry manufacturers, recognizing that substantial additional one-time characterization studies may be needed to document equivalence. Review of these studies is the province of the regulatory agency, but compendial tests can provide clarity and guidance in the process.

Biotechnology↗
PubMedDate not supplied

Computerized calculation of biological potency: presentation of the interactive computer program "POTENCY" (assays: "2 + 2" doses, "3 + 3" doses, "twin cross-over assay" and "probit analysis" ("2 + 2" doses).

Paper presents the interactive computer program "POTENCY" written in BASIC program language, based on the algorithm for classifying biological assays using the assays: "2 + 2" doses, "3 + 3" doses, twin cross-over assay and probit analysis ("2 + 2" doses) described in Yugoslav Pharmacopeia (Ph. Jug. IV). The program execution is presented by assay examples of biological potency calculation described in European Pharmacopeia (Eur. Ph. 1997). The assay-examples have simultaneously been the measure of program execution correctness.

Algorithms↗
PubMedDate not supplied

Honduran women received no written information on contraceptive pill.

In the period 1989-1994, Honduran women participating in the Project Health Sector 2 have been exposed to a contraceptive mini-pill, Ovrette. The Institute of Honduran Social Security (IHSS) approved the program (in which Ovrette distribution is included) in May 1990. The program is partly funded by the Population Council, which is funded by USAID Registry with the Department of Health was not required under the Health Code since Ovrette had entered the country as a donation. In June 1993, a Commission of the Honduran Medical Association reported that the women were not given any written information on the drug. Ovrette is an oral contraceptive manufactured by Wyeth. Its active ingredient is a progestagen, Norgestrel. Contraindications for Ovrette include: non-lactating women who exhibit side-effects such as dizziness, water retention, migraine, etc.; non-lactating women with contraindications for estrogen; lactating women who reject other contraceptive drugs. The US Pharmacopeia and the US Food and Drug Administration do not authorize the drug for use by lactating women. As with other progestagens, Norgestrel passes through to the mother's milk. In 1993, the US Pharmacopeia reported that these hormones can cause harmful effects to the child, and recommended switching medications or discontinuation of lactation. In 1983, the WHO expressed concern about the possibility of injury caused by the progestagens. The possibilities included alterations to personality, behavior, anatomy of sexual organs, reproductive capacity, immunological function and development of neoplasia. Possible damages in puberty or during the reproductive age are not known since there is no study of exposed children that are older than 12 years of age.

Americas↗
PubMed2002

Comparison of various requirements of the quality assurance procedures for (18)F-FDG injection.

The quality assurance (QA) requirements (i.e., test procedure, acceptance criteria, and testing schedule) for fludeoxyglucose (18)F ((18)F-FDG) injection listed in the U.S. Pharmacopeia (USP); the draft Chemistry, Manufacturing, and Controls (CMC) issued by the U.S. Food and Drug Administration (FDA); and the European Pharmacopeia (EP) were compared. The FDA Modernization Act of 1997 requires that the QA of compounded PET drug products be in compliance with the PET compounding standards and official monographs included in the USP. However, the "sunset" clause of the PET section within the FDA Modernization Act of 1997 stipulates that all PET drug products, in due course, must meet the requirements for drug approval procedures and current good manufacturing practice, and the FDA has issued a draft CMC that includes QA specifications for (18)F-FDG injection. The purpose of this article is to discuss the pros and cons of each of the QA tests stated in the USP, CMC, and EP and to propose a practical testing method for each required test, thereby helping end users to ensure the quality of the (18)F-FDG injection product. It is hoped that this article will stimulate further cooperation among various countries worldwide in the development of a set of harmonized and sensible QA standards for all PET drug products.

Drug Compounding↗
PubMedDate not supplied

Assessing parallelism prior to determining relative potency.

In the course of preparing a revision to Chapter (111) of the U.S. Pharmacopeia, the revision committee came to a unanimous agreement that the method for assessing parallelism that is currently presented in (111) and in the European Pharmacopeia's Chapter 5.3 is flawed and should be replaced. The symptoms are that perfectly acceptable assay results may fail due to good precision and that obviously faulty assay results may pass due to poor precision. The flaw is that the wrong statistical technique has been used. We propose an alternative approach based on the equivalence testing paradigm that does not have these shortcomings. Equivalence testing requires the establishment of equivalence limits. Specific approaches for establishing equivalence limits are discussed.

Data Interpretation, Statistical↗
PubMed1992

[Analysis of different ways of evaporation in Polish Pharmacopoeias].

Mechanism of evaporation of water from 13 pharmacopoeial organic hydrates using a thermogravimetric method was followed. Evaporation of water was analysed under the conditions described in the Polish Pharmacopeia IV. The results were compared with those obtained when dehydration was performed according to the other pharmacopeias.

Chemistry, Pharmaceutical↗
PubMed1999

Division of Medicinal Chemistry--general oral session/fellowship awards.

The primary purpose of this session was to recognize the outstanding achievements in the field of medicinal chemistry. The ACS award for Creative Invention went to researchers at Merck and Co Inc, who successfully developed Crixivan (indinavir, L-735524), an HIV-1 protease inhibitor, which received FDA approval in record time and is now used by over 300,000 patients worldwide. A former Merck scientist, John Baldwin (Pharmacopeia Inc, USA), was honored with the EB Hershberg award for Important Discoveries in Medicinally Active Substances. Dr Hershberg has been at the forefront of drug discovery technologies, such as combinatorial chemistry and rational drug design. During his 30-year career at Merck, he was involved with the Pepcid, Crixivan and Trusopt projects, but eventually left in 1993 when he co-founded Pharmacopeia.

Journal Article↗
PubMed1966

American medical literary firsts, 1700--1820, in the Countway Library.

A combination of two major collections, those of the Harvard Medical and the Boston Medical Libraries, took place at a formal dedication of the Francis A. Countway Library of Medicine in May of 1965. As a result of this unification the historian may now consult many significant primary source materials in one research collection in Boston. Many of these works are early imprints of medical Americana. This paper discusses twenty-four imprints, from 1700 to 1820, which were firsts of their kind in American medical literature. Presented are the first American medical publication, book, pharmacopeia, mortality statistics, anatomical illustrations, transactions of a medical society, medical journal, textbook of obstetrics, medical dictionary, textbook of medicine, and official pharmacopeia. Also discussed are the first works in this country on smallpox inoculation, scarlet fever, pleurisy, public health, medical education, medical ethics, the history of medicine, surgery, epidemiology, smallpox vaccination, dentistry, meningitis, and psychiatry. An exhibit of these items in the Countway Library is planned for the spring and summer of 1966.

History, 18th Century↗
PubMed1995

[Analysis of poisonous trace elements in huangwu gongmitai].

A comparative study was made on the dissolved amount of poisonous trace elements mercury and arsenic contained in hydrargyri subchloridum and realgar of gynecological suppository in artificially simulated vaginal acid-base liquid with that contained in hydrargyri subchloridum and realgar in artificial gastric juice stipulated in Pharmacopeia of China. The result shows that the dissolved amount of mercury and arsenic contained in the suppository is much smaller than that stipulated in Pharmacopeia for oral administration.

Arsenic↗
PubMed1976

Effect of glass on pH-dependent stability of typhoid vaccine.

Vaccines made from the Ty-2 strain of Salmonella typhosa were tested periodically for stability of pH and of potency. The acetone-treated cultures prepared in buffered saline solutions retained potency beyond 30 months of storage at 0 to 5 C. Similar vaccines in unbuffered saline solutions lost potency coincident with increase of alkalinity. Vaccines packaged in United States Pharmacopeia borosilicate glass vials retained potency and pH stability, whereas those in Type III United States Pharmacopeia soda-lime glass vials were less stable.

Animals↗
PubMed2026

Complementary activity of an ancient combination of natural ingredients on the dysbiosis symptoms linked to acne.

ETHNOPHARMACOLOGICAL RELEVANCE: Acne is one of the most common dermatologic diseases in the world. It is due to the secretion of a high level of sebum that causes follicular hyperkeratinisation, alterations of the cutaneous microbiota, and inflammatory processes. One of the first-line treatments is still an antibiotic prescription, that inhibits bacterial growth and, as a consequence, lowers some of the other symptoms. Nevertheless, this high level of antibiotic prescription contributes to the increase of antibiotic resistance. Alternatives to antibiotics are thus highly required, as acne does not represent per se an infection. AIM OF THE STUDY: In the frame of the IRGAP (Interdisciplinary Research Group on Ancient Pharmacopeias) consortium, different preparations dedicated to cutaneous ailments have been identified based on ancient traditional uses, dating back to Antiquity or Middle Ages. Among them, the combination of Aloe vera and Myrrh was widely conserved over centuries. Even though this combination is no longer in use, we wondered why this combination was so widely conserved. We considered the use of this combination of ingredients to treat acne, a case study for which both plants are still used, but separately. MATERIALS AND METHODS: The effects of both plant extracts were analyzed on the growth of different bacteria from the skin microbiota, cultivated alone or in co-culture conditions. As the skin is a rather heterologous environment, we further tested the robustness of our study by varying the experimental conditions. We further analyzed any complementary effects of these extracts on the inflammation process linked to acne. RESULTS: We showed that both plant extracts have complementary effects on micro-organisms and on macrophages. Indeed, while Myrrh extracts inhibited the growth of specific skin microbiota bacteria, Aloe vera gel extracts on the opposite, favored the growth of others: the two plants could act in a complementary way to restore a healthy microbiota. Another complementarity was also observed on macrophages: while Myrrh extracts showed an anti-inflammatory effect, Aloe vera gel extracts showed an antioxidant effect. CONCLUSION: Our results highlight the potential of the combination of Myrrh and Aloe vera to address both the dysbiosis of the skin microbiota and the inflammation associated with acne. Thus, this exploration of forgotten combinations from historical pharmacopoeias underscores the importance of revisiting past traditional knowledge as a source of innovation.

Aloe vera↗
PubMed1998

Changes in knot-holding capacity of sliding knots in vivo and tissue reaction.

OBJECTIVES: To evaluate and compare the in vivo strength, knot efficiency, and knot security of 4 types of sliding knots, and to assess tissue reaction to study the effect of knot configuration, knot volume, and suture size. DESIGN: Randomized trial. SETTING: Experimental Medical Research Institute, Istanbul, Turkey. SUBJECTS: Wistar rats. INTERVENTION: To assess the tissue reaction, a midline laparotomy incision was made in 112 rats and sutured with various interrupted knots in silk and nylon sutures of 2/0 and 4/0 (United States Pharmacopeia) sizes. Suture loops were implanted in subcutaneous pouches in the rat abdomen. Sutures were all extracted at days 4, 7, 11, and 20 to determine their knot-holding capacity. MAIN OUTCOME MEASURES: Knot efficiency and percentage decrease in knot-holding capacity were examined. Knot, tissue reaction, and inflammatory sheath volumes were measured. RESULTS: The 4/0 knots lost more strength than the 2/0 knots. The alternating knots with different patterns were more efficient and secure than the simple alternating ones. The alternating parallel knot was found to be unreliable. The tissue response to all the knots, except 2/0 nylon, was similar. The inflammatory sheath volume varied depending on the knot volume, suture size, and knot configuration. CONCLUSION: The use of alternating sliding knots with different patterns is recommended to replace simple alternating sliding knots.

Animals↗