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Using double zero-order model to test the release of dexamethasone implants
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Jian LE1, 2, 3, Xue ZHANG3, Wei-yue LU1, *, Hao WANG2, *
Acta Pharmaceutica Sinica | 2020, 55(6) : 1306 - 1311
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Acta Pharmaceutica Sinica | 2020, 55(6): 1306-1311
• Original Articles •
Using double zero-order model to test the release of dexamethasone implants
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Jian LE1, 2, 3, Xue ZHANG3, Wei-yue LU1, *, Hao WANG2, *
Affiliations
  • 1. Key Laboratory of Smart Drug Delivery, Ministry of Education, School of Pharmacy, Fudan University, Shanghai 201203, China
  • 2. National Pharmaceutical Engineering Research Center, China State Institute of Pharmaceutical Industry, Shanghai 201203, China
  • 3. Shanghai Institute for Food and Drug Control, Shanghai 201203, China
Published: 2020-06-12 doi: 10.16438/j.0513-4870.2019-1051
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Degradation of dexamethasone (DXM) is inevitable in the release test of dexamethasone implants (DI). In the release test conducted with flow-through cell method, the measured release curves of DI started to fall when cumulative release reached 70%-80%. Studies have shown that DI demonstrates a zero-order release rate of drug within every sampling interval, and a zero-order rate degradation in water (containing 0.05 mg·mL-1 benzalkonium chloride). Hence, this study establishes a double zero-order model (DZOM) to calculate the release during sampling intervals with the formula Ri = [Rim-R(i-1)m×(Cin/Ci0)]×2/(1+Cin/Ci0). At each sampling interval, we measure the initial and final drug contents in the release medium, and the concentrations of the active pharmaceutical ingredient (API) in the release medium obtained at the same condition of release test, to calculate the total released DXM from the implants including the degraded drug. This paper has also analyzed the reasons for the fluctuations in the drug release curve and the errors in the DZOM and provided solutions. Experimental results show that the DZOM has effectively solved the problems encountered in the normal release method (NRM). The DZOM can be a potential solution to drug degradation problems in the release tests of long-acting injections.

dexamethasone  /  implant  /  drug release  /  flow-through cell method  /  double zero-order model
Jian LE, Xue ZHANG, Wei-yue LU, Hao WANG. Using double zero-order model to test the release of dexamethasone implants[J]. Acta Pharmaceutica Sinica, 2020 , 55 (6) : 1306 -1311 . DOI: 10.16438/j.0513-4870.2019-1051
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Article Info
doi: 10.16438/j.0513-4870.2019-1051
  • Receive Date：2019-12-23
  • Online Date：2026-01-21
  • Published：2020-06-12
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History
  • Received：2019-12-23
  • Revised：2020-01-27
Affiliations
    1. Key Laboratory of Smart Drug Delivery, Ministry of Education, School of Pharmacy, Fudan University, Shanghai 201203, China
    2. National Pharmaceutical Engineering Research Center, China State Institute of Pharmaceutical Industry, Shanghai 201203, China
    3. Shanghai Institute for Food and Drug Control, Shanghai 201203, China
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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