RESUMO
21 patients with Paget's disease of bone and one with osteoporosis were studied to detect development of antibodies to salmon calcitonin during chronic therapy. Antibody titers ranged from 1:40 to 1:30,000 in plasma obtained after treatment of 11 patients. Radio-immunoelectrophoresis revealed that the antibodies were restricted to the gammaG class. One patient, W. O., with Paget's disease initially responded to treatment with a decrease in bone turnover, but later became resistant to the hormone in association with the appearance of a very high titer (1:30,000) of antibody against salmon calcitonin. A 1:10 dilution of his plasma was shown to completely inactivate 20 mMRC units/ml of salmon calcitonin as detected by bioassay in rats; slight inactivation was detected at a 1:200 dilution. All other patients continued to respond to salmon calcitonin despite the development of antibody to the hormone in ten cases. No evidence of systemic allergic reactions or other toxicity was found in any patient. The data suggest that although antibody formation may occur in as many as 50% of patients treated with salmon calcitonin, this antibody response is unlikely to be of clinical significance in most patients. However, in an occasional patient, a marked antibody response may occur which interferes with the therapeutic use of the hormone.
Assuntos
Anticorpos/análise , Calcitonina/uso terapêutico , Adulto , Idoso , Animais , Formação de Anticorpos , Autorradiografia , Calcitonina/administração & dosagem , Cálcio/sangue , Feminino , Humanos , Hidroxiprolina/urina , Imunoeletroforese , Imunoglobulina G , Injeções Subcutâneas , Isótopos de Iodo , Masculino , Pessoa de Meia-Idade , Osteíte Deformante/tratamento farmacológico , Osteíte Deformante/imunologia , Osteoporose/tratamento farmacológico , Osteoporose/imunologia , Hormônio Paratireóideo/sangue , Ligação Proteica , Salmonidae/imunologiaRESUMO
Sodium levothyroxine was quantitated in 25-300 micrograms/tablet formulations. The procedure consisted of pulverization of a suitable sample, extraction into acetonitrile-water (40:60, v/v) containing 0.05% o-phosphoric acid, and injection onto a bonded-phase cyanopropyl column; the effluent was monitored by UV detection at 225 nm. Spiked placebo recovery studies demonstrated the linearity of the method over the range of 80-120% of the label claim. Stability studies indicated that no degradation products or excipients interfered with the quantitation of the intact drug. Data demonstrating the accuracy and precision of this assay are presented, and the method was applied to the measurement of single-tablet content uniformity.