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We describe in this paper a new titration technique for phenobarbital using a cupric derivative of 1-methyl-3-o-nitrophenyl triazene N-oxide as a coloured indicator. The precision of the dosage with this method meets the requirements of the European Pharmacopeia.
Calcium supplements are widely used, yet many questions remain as to the absorption of various calcium salts. Because the solubility of many calcium salts is dependent upon pH, the type of salt used, the condition of the patient, and the time of administration should be considered. Studies show that many calcium supplements on the market today do not meet standards of quality established in the "U.S. Pharmacopeia" (USP). Consumers must be discerning about the products they purchase. Calcium supplements should be taken with meals to ensure solubility. Calcium carbonate, and particularly tribasic calcium phosphate tablets, are not recommended for patients with achlorhydria. Calcium tablets, like almost all drugs, should be taken with 8 ounces of water or other liquid.
Tissue reaction surrounding surgical knots was assessed histologically using a semiquantitative scoring system in 40 male Wistar rats. We tested sizes 2/0 and 4/0 (United States Pharmacopeia [USP]) coated polyglycolic acid and coated polyglactin-910 sutures, and two different knots. In addition, we measured the volume of the different knots and the total volume of tissue reaction surrounding the knots. Multivariate analysis showed only suture material and suture size to be independent factors determining tissue reaction. An increase of suture size resulted in a more than four- to sixfold increase in knot volume and a more than two- to threefold increase in the amount of the tissue-reaction sheath; however, the addition of extra throws to the knot enlarged the knot body by a factor of ony 1.5 and the tissue-reaction sheath by a factor of 1.0-1.9. These findings suggest that the use of thick-gauge suture material adds much more to the total amount of foreign body and tissue reaction in the wound than the addition of extra throws to the knot and might, therefore, be deleterious to optimum wound healing.
The F.I.P. has long been involved in the practical aspects of microbial quality in pharmaceuticals. This report deals with steam sterilization. A group of European experts from official laboratories and pharmaceutical industries has compiled this text which successively reviews the different pharmacopeias, defines some essential sterilization concepts and parameters, reviews the current approaches to steam sterilization and advises, for each of them, practices in validation and in-process control.
We report three cases of malaria by Plasmodium falciparum in travelers to West Africa, who had correctly followed, without interruption until the time of diagnosis, the prophylactic regimen that had been prescribed to them (chloroquine base 5 mg/week and pyrimethamine 50 mg/week). We point to the need to have, in Spain, a pharmacopeia which adequately covers the needs of travelers to tropical countries according to experience and international regulations, and also to have adequate health information available to international travelers.
Antidepressant drugs are now an important component of the analgesic pharmacopeia. Their ability to relieve pain is independent of the presence of clinical depression, and their efficacy has been documented in the treatment of migraine and tension headaches, neuropathic pain and chronic pain syndromes, including those associated with cancer. The tricyclic antidepressants are safe for use in patients with prolonged pain. The low doses required for analgesia are well tolerated and do not produce the side effects associated with the classic analgesic drugs.
Despite advances in the anesthetic pharmacopeia and improved noninvasive monitoring techniques, subjective bias and individual clinical experience remain major determinants of individual practice. Medicolegal pressures have increased in recent years, as has the concept of shared responsibility for surgical and anesthetic complications. New standards of anesthesia monitoring and practice are evolving in response to the need for perioperative risk management and cost-effective surgical care. Continued vigilance and close communication between the otolaryngologist and anesthesiologist remain key elements for safe anesthetic practice.
Allergic reactions can result from virtually any drug. In the pharmacopeia the possibility of an allergic reaction to a drug must be considered in any instance when a patient reports an adverse effect to a drug. Although most allergic reactions to drugs are mild, they may be severe and at times fatal. Thus, it is imperative that every physician understand the spectra of drug allergy, the methods for diagnosing, and the means of treating allergic reactions to drugs. This review places drug allergies within the context of the over-all spectra of adverse reaction to drugs, defines the spectra of allergic reactions in terms of the organ systems involved and the severity of the reactions, suggests mechanisms for diagnosing drug allergy by historical evaluation, and where possible, by skin testing procedures and provocative dose challenges, and provides a variety of methods for reintroduction of drugs to which patients have been demonstrated to be allergic. The most important aspect of allergic reactions to drugs, however, is the understanding on the part of the physician that any drug has the potential for causing an allergic reaction and that extreme vigilance in terms of the diagnosis and treatment of these reactions is necessary.
A rapid method is presented for detection and determination of anhydrotetracycline-HCl (ATC-HCl) and 4-epianhydrotetracycline-HCl (4-EATC-HCl) in tetracycline-HCl (TC-HCl). The method determines the 2 compounds as a sum, not individually. The first derivative absorption curve has a trough (D1) at 460 nm which is linearly related to concentration (1-10 mg/mL). ATC-HCl + 4-EATC-HCl content was determined in TC-HCl powder and capsules by the D1 and the compensation D1 spectrophotometric methods. The results were compared with those obtained using U.S. Pharmacopeia and British Pharmacopoeia methods.
Factor IX concentrates, prepared by standard chromatographic techniques, are used primarily to treat patients with congenital factor IX deficiency. A local factor IX containing concentrate has now been prepared and heat treated. Following heat treatment, and reconstitution, the potency is 280 units per vial. The preparation, HNZFIX, has been compared with the currently available factor IX concentrate Prothrombinex. Following administration into patients with haemophilia B, ex vivo factor IX recovery and half life response have been compared for the two products. The mean recovery values were identical with an average 17 units per litre rise in factor IX activity obtained for each unit of factor IX concentrate administered per kg of body weight. For both products recovery measured as the K ratio was approximately 75% (0.75). The plasma half life responses were 17 and 22.2 h for the HNZFIX and PTX respectively. No unexpected side effects occurred with the HNXFIX which met all the British Pharmacopeia requirements for a therapeutic concentrate.
Endotoxins liberated by gram-negative bacteria are frequent contaminants of aqueous and physiological solutions. Because of their potent biological effects in vivo and in vitro, their detection and removal are essential for the safe parenteral administration of products produced from natural sources, as well as those produced by recombinant DNA technology. Traditional methods of endotoxin detection include the U.S. Pharmacopeia rabbit test and the Limulus amebocyte lysate test. Elimination of endotoxins, however, continues to be a problem. Standard methods of sterilization, such as autoclaving or sterile filtration, have little effect on endotoxin levels. Various techniques for the prevention of endotoxin contamination and endotoxin removal have been discussed. The overall role of endotoxin prevention, detection, and elimination in biotechnology is emphasized.
For the investigation of plastics and elastics several sensitive biological methods are in use. In the Pharmacopeia of GDR, 2nd edition, a safety-test on isolated frogheart is prescribed for plastics and a safety-test on daphnia magna for elastics. Ionescu-Stoian had recommended a test using saccharomyces cerevisiae. We found a good conformity of the result given by this test with the results of the daphnia-test. On the other hand, the saccharomyces cerevisiae-test is much more sensitive than the test with isolated frogheart.
Production has started on a new Tc 99m sterile generator in Italy. We give the results of a series of quality controls in order to have a first evaluation of the product. The elution profile and the volume, activity, pH, aluminium concentration, 99 Mo content and radiochemical purity of the eluate were examined. Radiochemical purity tests were also carried out with some of the more widely used "in vivo" radiopharmaceuticals. The results are in line with the Official Pharmacopeia and good technical standards.
A new lidocaine-responsive liquid membrane electrode based on the use of the lidocaine reineckate ion pair complex in nitrobenzene solvent has been developed. The electrode displays a linear response for 10(-2)-10(-5) M lidocaine over the pH range of 3-6.5. The response time varies from 35 s to 1 min depending on the lidocaine concentration. The life span of the electrode is at least 1 month. Excipients and diluents commonly used in local anesthetic formulations do not interfere. Determination of lidocaine in some pharmaceutical preparations gives results with an average recovery of 99% of the nominal values and a mean standard deviation of 1.7% which compare favorably with those obtained by the U.S. Pharmacopeia method.
Lyophilized pancreas and pancreatic extracts are widely used in therapy of pancreatic exocrine function deficiencies. Among the measures for quality of the extracts, assay for lipolytic activity appears to be one of the best. However, assay precision is poor, because the specificity and mode of action of lipase requires careful optimization of the assay parameters, especially substrate and measurement conditions. In the method proposed here, substrate quality is improved by the use of sodium desoxycholate and a high-speed stirrer for more reproducible emulsions. Fatty acids are assayed by a titrimetric method, using an electronically monitored pH meter. A comparative statistical study of the U.S. Pharmacopeia method, the International Pharmaceutical Federation (FIP) method, and a modified FIP method showed the latter to have improved accuracy and reproducibility.
The U.S. Government has licensed seven Limulus Amebocyte Lysate manufacturers. Each manufacturer must determine the sensitivity of each lot by using the U.S. Standard Endotoxin, EC-5 which is identical to the U.S. Pharmacopeia (USP) Endotoxin Standard (Lot F). A licensed firm must be inspected annually and submit a protocol along with potency testing results on each lot of lysate before it can be released. The FDA tests each lot for at least potency before releasing it to be marketed. The release criteria for both the gelation and chromogenic lysate tests are discussed.
Laboratory and clinical studies were carried out to elucidate the anaphylactogenic qualities of the Bulgarian goinadotropic preparations PMS (an untreated and a freeze-dried formula), gravohormone, and luteoziman. Comparatively was assessed the sensitivity of three methods employed in the routine determination of drug anaphylactogenicity. One of them is the author's personal modification of a pharmacopeia method (U. S. P. XVII)--sensibilizing doses were introduced in guinea pigs subcutaneously, once daily, in the course of three days at 3-day intervals. The resolution dose was applied intraperitoneally on the 10th day following the last sensibilizing dose. The manifestation of anaphylaxia were recorded immediately after the introduction of the resolution dose or two hours later (at the very latest). Studies revealed that the preparations tested had no equal anaphylactic properties. In guinea pigs, sheep, and cattle PMS induced allergic reactions in 50 per cent of the examined series. In these animals both gravohormone and luteoziman did not generate such response. Suggested is the use of a U. S. P. XVII modified method (as cited above) to determine the anaphylactogenicity of gonadotropic preparations; it makes it possible to qualify such preparations for a shorter time. The new modification is readily applicable at a production control basis.
Liquid nitrogen storage of organisms designated in the U.S. Pharmacopeia (XIX) for the assessment of antimicrobial effectiveness is described. By use of simple apparatus and procedures, 85-95% viabilities of pre-frozen cells are attained immediately upon freezing. Viability levels have remained constant over a 3-year period and the use of such inocula has considerably improved the reliability of the test. The superiority of liquid nitrogen storage for microbial test inocular over other types of storage is discussed.