The aim of the present study was to evaluate the bioequivalence and therapeutic equivalence of the two most commonly prescribed L-thyroxine (monsodium L-thyroxine hydrate, CAS 25416-65-3) formulations in Brazil in patients treated for hypothyroidism. Twenty-four patients received 100 micrograms L-thyroxine daily of either Puran T4 (test) or the Brazilian reference formulation (reference) during 42 days, in a two-period crossover design. Serum samples obtained over a 24-h interval were analyzed for their total T4 concentration by a chemiluminescent immunoassay. Content and uniformity of the tablets and dissolution studies were also assessed according to USP 24 monograph using an isocratic HPLC-UV system and a rotating-paddle method. The mean pharmacokinetic parameters for total T4, expressed as geometric means (CV), for the test and reference were, respectively: Cmax (microgram/dl) 9.8 (14.3%) and 10.8 (14.9%); AUC0-24 h (microgram/dl.h) 206.8 (13.9%) and 230.4 (14.9%). Median values (90% CI) for Tmax (h) were 3 (2-3) and 2 (2-4) for the test and reference, respectively. 90% CI for ratios of LogCmax and LogAUC0-24 h were 86.6-94.9 and 86.3-93.4, respectively. Although the test exhibited values of Cmax and AUC0-24 h around 10% lower than the reference, these formulations must be considered bioequivalent since the 90% CI for both Cmax and AUC0-24 h mean ratio were within the 80-125% interval as proposed by the US Food and Drug Administration and the Brazilian legislation. TSH dosages within the normal range further support therapeutic equivalence between the two formulations. Dissolution data were roughly in agreement with in vivo results since both formulations comply with the USP dissolution criteria although the test tablets had a slower dissolution rate than the reference tablets. As a conclusion, the two oral formulations of L-thyroxine are both bioequivalent and therapeutically equivalent although presenting a small difference in their extent of absorption. Noteworthy, the dissolution profiles of the tablets correlate well with their bioavailability in the present experimental conditions.
Discutimos um caso incomum de doença de Paget do osso, de apresentação nos maxilares. Esta forma rara de manifestação de uma doença sistêmica levou à dificuldade inicial em estabelecer o diagnóstico, sendo a etiologia firmada apenas pela biópsia da lesão. Utilizamos bisfosfonatos com boa resposta. Ressaltamos no artigo a necessidade do acompanhamento multidisciplinar desses pacientes devido às complicações odontológicas da doença quando localizada nos maxilares.
An unusual case of Paget's disease of bone, presenting as a maxillary disease, is discussed. This rare manifestation of a systemic disease led to an initial difficulty in establishing the diagnosis; indeed, the etiology was only determined after the lesion biopsy. Bisphosphonates were used with a good response. We highlight in this article the need for a multidiscipli-nary follow-up of such patients due to odonthological complications of the disease when localized in the jaw
Este relato mostra o caso de uma paciente com mucocele gigante do seio esfenoidal, apresentando-se como massa intracraniana, invadindo a sela túrcica e levando à disfunção hipofisária com deficiência córtico e somatotrófica. Revendo a literatura, não foram encontrados casos semelhantes, Desta forma, serão discutidos alguns relatos de caso de mucoceles que se apresentaram como massa intracraniana e a reversibilidade da função hipofisária após a cirurgia descompressiva.
This paper reports the case of a patient with a giant mucocele of the sphenoidal sinus, which presented like an intracranial mass, invading the sella and leading to pituitary dysfunction with somatotrophic and corticotrophic deficit. A literature search reveals no other reports of such cases. Thus, we discuss some reported cases of intracranial masses associated with mucoceles and the reversibility of the pituitary function after decompressive surgery
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