Self-setting type of calcium phosphate cement (CPC) was developed by Brown and Chow in 1986 on the basis of the solubility phase chart of calcium phosphate.1) CPC can be prepared by having semi-stable type calcium phosphate transit to hydroxyapatite (HAP) by kneading it with a diluted phosphate solution. CPC preparations containing aspirin, 2) mercaptopurine, 3) cephalexin, 4) norfloxacin, 5) vancomycin, 6) insulin, 7) indomethacin, [8][9][10] and estradiol 11,12) have been reported. However, the methods for the dissolution tests used in these studies varied, and few systematic studies have been conducted about the release of drugs from CPC preparations. We, therefore, studied drug release from CPC preparations using nifedipine (NF) by the three dissolution test methods, i.e. the shaking method (SK), Japanese Pharmacopoeia XIV (JPXIV) paddle method (PD), and JPXIV flow-through cell method (FT). Presently, slow-release preparations of NF are in wide clinical use, but the development of preparations that can better control its release is still considered to be significant. In addition, NF, which is very stable to humidity, 13) was used as a model drug in this study, because this property was considered to be extremely advantageous for CPC preparations, which self-set under a high humidity condition. A.). All other solvents and reagents were commercial products of analytical grade and were used without further purification.Preparation of CPC The calcium phosphate cement (CPC) was prepared according to the procedure described by Otsuka et al. 9,10) The bulk CPC powder system used was a mixture of TTCP (1.83 g), DCPD (0.86 g) and HAP 1.79 g (40%) seed crystals. The bulk cement powder (0.50 g) was mixed with 0.25 ml of 25 mM H 3 PO 4 solution for 1 min to form a paste, then NF powders (1 mg (0.2%), 5 mg (1%) or 10 mg (2%)) were added to this mixture. The final paste was poured into two plastic molds (diameter 15 mm, thickness 2 mm, i.e. 353 mm 3 /pellet), and stored in a dark desiccator at 37°C and 100% relative humidity for 24 h. The resulting hardened CPC pellets were obtained by removing them from the mold. The weight of a CPC pellet was 250Ϯ10 mg. Transition of CPC to HAP was confirmed by powder X-ray diffraction analysis (Geigerflex RAD-C system, Rigaku Co., Tokyo, Japan) and Fourier-transformed infrared (FT-IR) spectrophotometer (FT/IR-300E, Jasco Co., Tokyo, Japan).Dissolution Medium A simulated body fluid (SBF) 14) with ion concentrations nearly equal to those of human blood plasma was used for dissolution medium of all dissolution tests. The composition of SBF was 142.0 mM Na . NaCl, NaHCO 3 , KCl, K 2 HPO 4 , MgCl 2 , CaCl 2 , and Na 2 SO 4 were dissolved with distilled water, and this fluid was buffered at pH 7.25 with 50 mM Tris and 45 mM hydrochloric acid (HCl), and its temperature was maintained at 37°C. The release rates from all CPC pellets containing the drug were measured as follows.Shaking Method (SK) SK was carried out by a minor modification of the method of Otsuka et al. 15,16) The CPC pellet wa...
Objective To examine the effect of angiotensin II receptor blocker (ARB) treatment on serum potassium level and hyperkalaemia risk in a clinical setting with inpatients and outpatients using calcium channel blockers (CCBs) as a reference standard. Methods The increased risk of hyperkalaemia associated with ARB treatment is known, however only a few studies have used an active comparator to examine this risk. In this retrospective study at a 320-bed general hospital in Japan, the hospital information system was used to identify patients with at least one prescription for an ARB (819 patients) or a CCB (1015 patients) who were naive to these drugs before study initiation. Serum potassium levels before and after ARB treatment were compared. Additionally, the unadjusted and adjusted hazard ratios for the risk of hyperkalaemia in the ARB and CCB users were estimated. Results The serum potassium level was higher in patients receiving ARB treatment (0.05 mEq/L, p=0.02) compared with those on CCB treatment. However, there was no significant association between ARB use and hyperkalaemia (adjusted HR 0.91, 95% CI 0.42 to 1.99, p=0.82). ConclusionThe increase in serum potassium level after ARB initiation makes it necessary to monitor serum potassium levels continuously during ARB treatment; however, the risk of hyperkalaemia appeared to be similar for ARB and CCB treatments.
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