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The Lipid Formulation Classification System Consortium is an industry-academia collaboration, established to develop standardized in vitro methods for the assessment of lipid-based formulations (LBFs). In this first publication, baseline conditions for the conduct of digestion tests are suggested and a series of eight model LBFs are described to probe test performance across different formulation types. Digestion experiments were performed in vitro using a pH-stat apparatus and danazol employed as a model poorly water-soluble drug. LBF digestion (rate and extent) and drug solubilization patterns on digestion were examined. To evaluate cross-site reproducibility, experiments were conducted at two sites and highly consistent results were obtained. In a further refinement, bench-top centrifugation was explored as a higher throughput approach to separation of the products of digestion (and compared with ultracentrifugation), and conditions under which this method was acceptable were defined. Drug solubilization was highly dependent on LBF composition, but poorly correlated with simple performance indicators such as dispersion efficiency, confirming the utility of the digestion model as a means of formulation differentiation., (Copyright © 2012 Wiley Periodicals, Inc.)

Background: The purpose of the present paper was to review the management of men referred to a breast clinic with presumed gynaecomastia., Methods: A retrospective analysis was carried out of 175 men over the age of 16 years who presented with breast enlargement and/or 'lumps', during a 7-year period to a single-surgeon. All patients had complete biochemical assessment (liver function tests, gamma-glutamyl transferase, prolactin, alpha-fetoprotein, beta-human chorionic gonadotropin), and mammography and/or ultrasound with fine-needle biopsy if indicated., Results: One hundred and seventy-five men, median age 44 years (range: 18-89 years), were assessed. Thirty-nine had bilateral true gynaecomastia and 88 had unilateral gynaecomastia (53% left). Carcinoma of the breast was diagnosed in eight, pseudo-gynaecomastia in 18, 13 had physiological pubertal changes only and nine had other diagnoses. Adverse drug reactions were possibly implicated in the aetiology of 47 patients, alcohol in seven patients, cannabis in one patient, testicular malignancy in four patients and hepatocellular carcinoma in one patient. Five patients were found to have hyperprolactinaemia. Twenty-four per cent of patients were reassured without intervention; 18% failed to attend follow up. Sixteen per cent were treated with danazol, 15% underwent surgery and 28 were referred for management of their cause. Danazol was effective in 81%, and three patients required surgery when danazol was ineffective. One further patient developed testicular cancer 9 months after presentation., Conclusion: Men presenting to a breast clinic require clinical assessment to exclude diagnoses other than gynaecomastia. True gynaecomastia can be managed with exclusion of causative factors by non-invasive investigation and examination. Many patients can be reassured as to the idiopathic nature of the condition and many will fail to attend follow up. Danazol is successful in some patients and surgery should be reserved for resistant cases.

The study compares the effectiveness and acceptability of three regimes of postcoital contraception: 1) ethinylestradiol 100 micrograms/levonorgestrel 500 micrograms repeated after 12 hours (Yuzpe method); 2) danazol 600 mg repeated after 12 hours; and 3) RU486 600 mg single dose. Between 1 April 1990 and 15 October 1990, 215 women were selected and randomly allocated to the three treatment groups. One hundred and sixty eight were fully followed up, 35 ongoing and 8 lost to follow-up. All women had regular cycles and were aged 16-45 years. All treatments were given within 72 hours of unprotected intercourse and follow-up was until normal menstruation or diagnosis of pregnancy. beta-HCG was measured quantitatively where there was a suspicion of pregnancy. The data obtained show similar failure rates (Yuzpe 1/57, danazol 2/57, RU486 1/54) but more side-effects in the Yuzpe group (nausea 74.1%, vomiting 22.4%, breast tenderness 22.4%) than in the other two (danazol: nausea 31.6%, vomiting 3.5%, breast tenderness 19.3%) and (RU486: nausea 36.4%, vomiting 3.6%, breast tenderness 23.6%). There was one apparent allergic reaction in the danazol group. RU486 caused greater cycle disturbance, prolonging the cycle considerably. Initial results suggest that danazol and RU486 may be much more acceptable methods of postcoital contraception due to reduced side-effects and, in the latter case, single dose. Although numbers are small at present, the effectiveness of the newer methods appear similar to Yuzpe.