A self-setting TTCP-DCPD apatite cement for release of vancomycin

Hamanishi, Chiaki; Kitamoto, Katsunori; Tanaka, Seisuke; Otsuka, Makoto; Doi, Yutaka; Kitahashi, Toshihiro

doi:10.1002/(sici)1097-4636(199623)33:3<139::aid-jbm3>3.0.co;2-r

Cited by 90 publications

(40 citation statements)

References 15 publications

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“…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.…”

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confidence: 99%

Dissolution Tests for Self-Setting Calcium Phosphate Cement-Containing Nifedipine.

Suzuki

Arai

Goto

et al. 2002

CHEMICAL & PHARMACEUTICAL BULLETIN

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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...

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confidence: 99%

Dissolution Tests for Self-Setting Calcium Phosphate Cement-Containing Nifedipine.

Suzuki

Arai

Goto

et al. 2002

CHEMICAL & PHARMACEUTICAL BULLETIN

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“…3,5,7,10,34,[39][40][41][42][43][44][45] We chose a powderpowder mixture here followed by compression to allow incorporation of the TA into the matrix core. Two techniques are proposed: dynamic compaction and isostatic compression.…”

Section: Discussionmentioning

confidence: 99%

“…6,7 The development of techniques using antibiotic cements has proven to be extremely effective in treating these infections. [8][9][10][11][12][13] Although the cements provide high local antibiotic concentrations in situ for a few weeks, 14,15 they are nondegradable. Thus, a biodegradable biomaterial, allowing the release of large amounts of a therapeutic agent (TA) with no need for a second surgical procedure to remove it, would be more convenient.…”

Section: Introductionmentioning

confidence: 99%

Influence of isostatic compression on the stability of vancomycin loaded with a calcium phosphate-implantable drug delivery device

Gautier

Caillon²,

Ray

et al. 2000

J. Biomed. Mater. Res.

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It is essential to prevent microbial infections after osteoarticular trauma or prosthesis implantation. As an alternative to antibiotic parenteral administration, antibiotic-loaded biomaterials allow high concentrations to be obtained in situ without systemic toxicity. Although the formulation of biphasic calcium-phosphate (BCP)-vancomycin granules by isostatic compression has recently been used to produce drug-delivery devices, the stability of vancomycin needs to be proven. In this study, vancomycin was associated with BCP powders by isostatic compression at 100, 140, or 200 MPa and then extracted or released by a rotating paddle system for 24 h. Vancomycin assays were performed by spectrophotometric and microbiological methods. The results show that all vancomycin associated with the material was recovered after extraction without degradation. Thus, vancomycin was not denaturated after application of 100, 140, or 200 MPa of isostatic compression. The results for vancomycin released from granules compressed at the three pressures were not significantly different (p =.01) whether assays were performed microbiologically or spectrophotometrically, indicating a good correlation between the two methods. This process involving high pressure appears to be a good means of developing drug delivery devices loaded with therapeutic agents without denaturating the components.

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“…Abb. 4 Bei der Entwicklung solcher Pasten ist insbesondere die Modellierbarkeit [27] und der isothermische Härteprozess [32] propagiert worden, was grundsätz-lich die Zudosierung thermisch labiler Antibiotika erlaubt. Zudem wurde eine Druckfestigkeit ermittelt, die nach ca.…”

Section: Characteristicsunclassified