RESUMEN
A recent report suggested that some folic acid preparations available in the United States failed to meet the specifications for dissolution specified by the US Pharmacopoeia (USP), of 70 per cent drug release in the first hour of testing. The Teratology Society recommends that women of childbearing age should take a daily supplement of 400 microg folic acid when they are trying to conceive, to reduce the risk of foetal neural tube defects. The consequence of this failure to meet the USP requirements may be that an inadequate dose of folate may be absorbed and thus the expected level of protection against neural tube defects not afforded. The purpose of the present study was to examine a number of brands of folic acid (400 microg), available commercially in the United Kingdom, for compliance with the British Pharmacopoeia (BP) test for dissolution. Ten tablets (or capsules) from each of 11 brands were tested using dissolution apparatus compliant with BP requirements, using 0.1 M sodium hydroxide as the dissolution medium. The results indicated that four of the brands failed to release 70 per cent of the nominal drug content in the first hour of test and thus did not comply with the test. Two of the seven brands that passed the test went on to release more than 150 per cent of the nominal 400 microg drug content. These results highlight the problems of dose uniformity and the potential health risks of slow dissolution and under-dosing in commercially available folic acid dosage forms.
Asunto(s)
Suplementos Dietéticos/normas , Ácido Fólico/farmacocinética , Ácido Fólico/normas , Farmacopeas como Asunto/normas , Absorción , Calibración , Femenino , Ácido Fólico/administración & dosificación , Adhesión a Directriz , Humanos , Defectos del Tubo Neural/prevención & control , Embarazo , Espectrofotometría Ultravioleta , Medicina Estatal , Comprimidos/química , Reino UnidoRESUMEN
Direct delivery of progestogens to the uterus may be of use in the treatment of dysfunctional uterine bleeding and the sequelae of the menopause as it has the potential to overcome the problems of systemic administration. This study characterised the release of norethisterone and levonorgestrel into an aqueous medium from hollow nylon fibres with dimensions suitable for easy insertion through the post-menopausal cervix. Cell culture techniques were used to assess potential cytotoxic and teratogenic effects. The results demonstrated that the hollow fibres released norethisterone and levonorgestrel at mean rates of 0.5 and 0.6 micrograms/day over 14 days, respectively. There were indications, however, that both steroids were toxic to endometrial cells at concentrations of approximately 5 micrograms/ml, and both drugs showed signs of potential teratogenicity at 10 micrograms/ml. Delivery of the same doses of norethisterone using the hollow fibres reduced the effects on the endometrial and fetal cells. Delivery of levonorgestrel from the hollow fibres had no effect on the endometrial cell toxicity but potentiated the effects on the fetal cells. These results suggest that the hollow nylon fibres may be of use for the delivery of norethisterone to the uterus but that they are inappropriate for the delivery of levonorgestrel.
Asunto(s)
Anomalías Inducidas por Medicamentos , Anticonceptivos Sintéticos Orales/administración & dosificación , Sistemas de Liberación de Medicamentos , Levonorgestrel/administración & dosificación , Noretindrona/administración & dosificación , Animales , Células Cultivadas , Femenino , Levonorgestrel/toxicidad , Noretindrona/toxicidad , Nylons , Embarazo , Ratas , Ratas WistarRESUMEN
An audit was carried out in an NHS trust to identify the degree to which wound management products were being selected and used appropriately. Fifty patients with various types of wounds were involved; observers noted the condition of wounds at dressing changes and the procedures used, then studied each patient's hospital documentation (medical notes, nursing care plan and drug chart). Nursing staff were interviewed to ascertain the input of various disciplines in dressing choice. The 'correct' choice of dressing was made in only 48% of wounds, and correct choice and use were identified in just 20%, with wide variations between different products. A quarter of patients reported pain associated with their wounds, but none received analgesia before dressing changes. As a result of the audit, new guidelines on dressing choice and use have been produced, with others in preparation, and the hospital formulary has been amended.
Asunto(s)
Vendajes/normas , Evaluación en Enfermería/normas , Selección de Paciente , Heridas y Lesiones/enfermería , Vendajes/provisión & distribución , Humanos , Auditoría de EnfermeríaRESUMEN
The effects of systemic norethisterone acetate and oxytetracycline hydrochloride on the levels of vaginal microorganisms found in the uterus after the insertion of transcervical, intra-uterine monofilaments in the guinea-pig were determined. The results indicated that bacteria were transferred to the uterus from the vagina during the insertion process and, in the presence of an intra-uterine substrate, persisted for up to 6 months. Daily treatment with norethisterone acetate or oxytetracycline hydrochloride whilst the monofilament was in-situ failed to reduce the bacterial numbers in the uterus. Similarly, daily treatment with oxytetracycline hydrochloride for the 5 days before monofilament insertion had no effect on these bacteria.
Asunto(s)
Bacterias/efectos de los fármacos , Dispositivos Intrauterinos/efectos adversos , Noretindrona/análogos & derivados , Oxitetraciclina/farmacología , Congéneres de la Progesterona/farmacología , Útero/microbiología , Vagina/microbiología , Animales , Bacterias/aislamiento & purificación , Recuento de Colonia Microbiana , Femenino , Cobayas , Inyecciones Intraperitoneales , Noretindrona/administración & dosificación , Noretindrona/farmacología , Acetato de Noretindrona , Oxitetraciclina/administración & dosificación , Congéneres de la Progesterona/administración & dosificación , Útero/efectos de los fármacosRESUMEN
The effects of transcervical, intrauterine monofilaments on guinea pig uterine microflora were determined. The results indicated that bacteria were transferred to the uterus during the insertion process, although in sham control animals these bacteria were eradicated within 10 days. In the presence of an intrauterine substrate the bacteria within the uterus persisted for up to 6 months. Electron micrographs showed that bacteria were adhered to the monofilament within a biofilm, although some bacteria were planktonic.
Asunto(s)
Bacterias/crecimiento & desarrollo , Dispositivos Intrauterinos/efectos adversos , Enfermedad Inflamatoria Pélvica/etiología , Útero/microbiología , Animales , Bacterias/ultraestructura , Femenino , Cobayas , Microscopía Electrónica de Rastreo , Factores de TiempoRESUMEN
Using guinea-pigs as a mammalian model, the effects of bromhexine hydrochloride, ethinyloestradiol, norethisterone acetate and prednisolone acetate on uterine microbial status were determined. Those drugs known to decrease mucus viscoelasticity predisposed to the entry of vaginal bacteria into the uterus, probably due to reduction of the cervical mucus barrier. Norethisterone acetate, which increases cervical mucus viscoelasticity, reduced these effects. The effects produced by the steroid hormones were independent of their immunosuppressive effects. The results also suggest that prednisolone acetate may exert oestrogen-like actions on cervical mucus.
Asunto(s)
Etinilestradiol/farmacología , Expectorantes/farmacología , Noretindrona/farmacología , Prednisolona/farmacología , Útero/microbiología , Animales , Bacterias/aislamiento & purificación , Etinilestradiol/administración & dosificación , Expectorantes/administración & dosificación , Femenino , Cobayas , Recuento de Leucocitos/efectos de los fármacos , Noretindrona/administración & dosificación , Prednisolona/administración & dosificación , Útero/efectos de los fármacosRESUMEN
This study used guinea-pigs as a mammalian model to investigate the effects of bromhexine hydrochloride and S-carboxymethyl-L-cysteine on the integrity of the cervical mucus plug. It was shown that under normal circumstances the uterus is sterile, but following drug administration microorganisms began to appear in the uterus with no significant effect on the vaginal microbial population. It therefore appears that these two mucolytic agents may reduce cervical mucus viscoelasticity. After the animals had been mated, microorganisms were isolated from the uterus even in the absence of drug treatment.