Direct spectrofluorimetric methods as alternatives to compendial ones used for the quality control of biopharmaceuticals: development, validation and application

Abstract A simple, rapid, precise, accurate and sustainable spectrofluorimetric method (SFM) was developed, validated and applied for the determination of 4-aminobenzoic acid and aromatic amino acids (phenylalanine, tryptophan and tyrosine). These compounds are used in biopharmaceutical formulations and therefore must be analyzed by quality control laboratories to meet the criteria established in pharmacopoeias. In general, potentiometric titration (PT) is described in the compendia as the official analytical technique. However, this method showed low sensitivity and selectivity, and moreover was performed with a non-aqueous solvent (acetic acid), which led to higher consumption of reagents and consequently to the formation of residues. Therefore, the SFM was developed in aqueous medium at pH 7.2 using phosphate buffer. It was successfully validated according to the ICH guidelines and showed good linearity range (r>0.999), specificity, accuracy and precision (within and between days) and robustness. The test results were compared between the SFM and PT using raw material samples, while according to the F- and t-tests at 95% confidence level, no statistical difference was found between the methods.

The Efficacy of Medical Treatment of Peyronie's Disease: Potassium Para-Aminobenzoate Monotherapy vs. Combination Therapy with Tamoxifen, L-Carnitine, and Phosphodiesterase Type 5 Inhibitor

PURPOSE: This study was designed to evaluate the efficacy of medical treatment of Peyronie's disease. MATERIALS AND METHODS: A total of 109 patients with Peyronie's disease who had been treated from January 2011 to December 2014 were retrospectively reviewed in this study. Forty-four patients (Group 1) were treated with 12 mg of potassium para-aminobenzoate daily. Sixty-five patients (Group 2) were treated with combination therapy: tamoxifen (20 mg) and acetyl-L-carnitine (300 mg) twice daily in addition to a phosphodiesterase type 5 inhibitor. Ability to perform sexual intercourse, pain during erection, size of plaque, and penile curvature angle were assessed. RESULTS: In Group 1, 30 of 44 patients (68.2%) discontinued treatment within 12 weeks, while 5 patients (7.7%) in Group 2 discontinued treatment. Pain during erection and plaque size were improved in both groups but showed no statistical difference due to the high dropout rate in Group 1. In both groups, penile curvature was improved, but demonstrated no statistical difference between the treatment groups. However, combination therapy demonstrated a better response rate in patients whose penile curvature angle was less than 30° (44.4% vs. 79.1%, p=0.048). The rate of successful sexual intercourse was significantly higher in Group 2 (42.8% vs. 78.3%, p=0.034). The number of patients who underwent surgical correction despite medical treatment was significantly higher in Group 1 (35.7% vs. 13.3%, p=0.048). CONCLUSIONS: Early medical combination therapy in Peyronie's disease may present better results in patients whose curvature angle is less than 30°.

Effect of Potassium Aminobezoate in Oral Therapy for Peyronie's Disease: Preliminary Study / 대한남성과학회지

PURPOSE: To evaluate the effect and improvement of potassium aminobenzoate (500 mg Peyron capsule) in oral therapy for Peyronie's disease. MATERIALS AND METHODS: From February 2011 to September 2011, 31 patients with Peyronie's disease received potassium aminobezoate (500 mg Peyron capsules) and were divided into two groups. Group 1 (N=10) received potassium aminobezoate (500 mg Peyron capsule) 3 g four times daily without previous treatment of Peyronie's disease, while group 2 (N=21) received the same drug with previous treatment of Peyronie's disease (10 mg Tamoxifen +300 mg L-carnitine two times daily). Outcomes were assessed by subjective symptom change, pain relief, resolutions of the plaque, and curvature. RESULTS: After 3 months, there were no significant improvements in clinical outcomes of either group and among all the patients, 23 stopped taking potassium aminobezoate (23/31, 74%). The reasons for ceasing the therapy were gastrointestinal trouble (8/23, 35%), too many doses to take (7/23, 30%), ineffectiveness (6/23, 26%), and high price (2/23, 9%). CONCLUSIONS: Athough the etiology of Peyronie's disease has not been elucidated, potassium aminobenzoate in therapy of Peyronie's disease has been used. The use of this medication has the limitations of gastrointestinal trouble, ineffectiveness, too many doses, and high price. Further evaluations of the effect and appropriate dosing of potassium aminobenzoate are needed.

Effects of aprotinin versus tranexamic acid on blood coagulation and platelet function in patients undergoing valve replacement / 中华麻醉学杂志

Objective It has been shown that aprotinin and tranexamic acid are equally effective in protecting platelet and reducing postoperative bleeding. The aim of this study was to compare the effects of aprotinin and tranexamic acid on blood coagulation. Methods Thirty patients undergoing elective valve replacement were randomly divided into two groups : (1) aprotinin group (AP, P