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Study on Azithromycin Gelatin Microsphere Suspension

Author: LiuXingChen
Tutor: YangFan
School: Guangdong College of Pharmacy
Course: Pharmacy
Keywords: AZM microsphere extracorporeal release suspension
CLC: R94
Type: Master's thesis
Year: 2008
Downloads: 316
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Abstract

Considering the physics and chemistry characteristic of AZM, the study designed a new preparation taking AZM as the drug pattern which can conceal the bitterness of AZM. At the same time, it is easy to eat by baby patient. The outstanding characteristic is that we make AZM as AZM-GMS and then prepare suspension using AZM-GMS as transit material. Because of the low dissolvolusion and bioavailability, we bound it up in GMS first so it can not be release immediately. To do that can not only improve its bioavailability but also cover its bitterness effectively. Making AZM-GMS to suspension and adding corrective in further, we can cover the bitterness of AZM twice. The experiment result tells us that it can release drugs more than 85% in 30 minutes. It can reduce the side effect so it may be more safely for us to eat. Through experiment AZM-GMS suspension can conceal the bitterness of AZM effectively within 20 seconds. It is easy to eat by baby patient.Because gelatin’s low-price low side effect and body degradation, we take it as carrier material. We studied AZM’s related characteristic such as melting point and max absorption. The result is OK by Pharmacopoeia. We studied the affect to GMS’s drug loading and drug embedding of gelatin’s kinds, state of gelatin’s powder, O/W modulus, proportion of drug and carrier, way of mixing, the kind of dehydrating agents, the kind of solidifying agents, the time of solidification. Taking AZM-GMS’s state, diameter, drug loading and drug embedding as index, we make out the best preparation of AZM-GMS. The kind of gelatin is A, the temperature of emulsifying is 35～40℃, emulsifying time is 10～15min, proportion of O/W is 5:1, proportion of AZM and carriers is 1:1, concentration of gelatin is 10%, concentration of emulsify is 2%. We made six batches of AZM-GMS by the best preparation and studied the characteristics fully such as drug concentration and GMS’s state. We can see that the AZM-GMS are yellow powder and from the optical micrograph we can see the AZM-GMS are circle. AZM-GMS’s drug loading is 20.11±0.57 %(g/g), drug embedding is 59.55%(g/g) and average diameter is 58.34μm. We took the test of accelerating stability and the test of room temperature stability and the results are good.Taking Amylum, Lactose, Mannitol, Arab glue as assist material, we prepared AZM-GMS suspension by AZM-GMS. The results show that the stability of AZM-GMS suspension is bad and the redispersity is normal. We can see from the results of release curve that AZM-GMS suspension can release more than 85% drugs in 0.1mol/LHCl within 30 minutes. The results of covering bitterness test show that AZM-GMS suspension can cover the bitterness of AZM well.The study bounded AZM up into AZM-GMS and then made it AZM-GMS suspension. In this way, we can not only improve AZM’s bioavailability, reduce the side affect and cover the bitterness, but we make it easy to eat for baby patient. It is meaningful and I’m sure it will have a good future.

Study on Azithromycin Gelatin Microsphere Suspension

Abstract

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