A Study on Stability of Certain Antibiotic Products Under Different Storage Conditions in Egypt
Nagwa Ali Mohamed Sabri;
Abstract
Abstract
Drug product stability is an indespensible requirement that has to be met throughout the period of storage and use. Since environmental factors affect the stability of drug products, therefore, improper storage affects not only the active ingredient but also the organoleptic properties of the drug products. Hence, bioavailability and antibacterial activity will
be ultimately and consequently affected and may be reduced.
ln Egypt, most drug storage areas suffer from lack of properly controlled and monitored conditions of temperature and humidity. This may be a serious problem since improperly elevated storage temperatures can mimic unplanned and uncontrolled accelerated stability studies. Moreover, the climate in Egypt varies with season and place. It corresponds to mediterranean like subtropical climate, humid tropical
climate and also hot humid climate.
Ampicillin and rifampicin products were proven through years to be widely used antibiotics in Egypt. In this study their stability was extensively studied to monitor the storage conditions of pharmacies and
drug stores in different areas in Egypt.
The stability of ampicillin is known to be affected by temperature, humidity and pH. The dosage form excipients and concomitant use with other drugs are among factors affecting physical and chemical stability of
ampicillin dosage forms. Decomposition of ampicillin in solid-state
f involves the B-laclam bond, and il can occur as a simple first-order reaction or may be a more complex process. In the presence of OH-ions,
degradation of ampicillin is second-order.
Rif 1mpicin is very stable in ihe solid slate in sealed containers at room temperature (25°C). While in aqueous solution, rifampicin
-I-
Drug product stability is an indespensible requirement that has to be met throughout the period of storage and use. Since environmental factors affect the stability of drug products, therefore, improper storage affects not only the active ingredient but also the organoleptic properties of the drug products. Hence, bioavailability and antibacterial activity will
be ultimately and consequently affected and may be reduced.
ln Egypt, most drug storage areas suffer from lack of properly controlled and monitored conditions of temperature and humidity. This may be a serious problem since improperly elevated storage temperatures can mimic unplanned and uncontrolled accelerated stability studies. Moreover, the climate in Egypt varies with season and place. It corresponds to mediterranean like subtropical climate, humid tropical
climate and also hot humid climate.
Ampicillin and rifampicin products were proven through years to be widely used antibiotics in Egypt. In this study their stability was extensively studied to monitor the storage conditions of pharmacies and
drug stores in different areas in Egypt.
The stability of ampicillin is known to be affected by temperature, humidity and pH. The dosage form excipients and concomitant use with other drugs are among factors affecting physical and chemical stability of
ampicillin dosage forms. Decomposition of ampicillin in solid-state
f involves the B-laclam bond, and il can occur as a simple first-order reaction or may be a more complex process. In the presence of OH-ions,
degradation of ampicillin is second-order.
Rif 1mpicin is very stable in ihe solid slate in sealed containers at room temperature (25°C). While in aqueous solution, rifampicin
-I-
Other data
| Title | A Study on Stability of Certain Antibiotic Products Under Different Storage Conditions in Egypt | Other Titles | دراسه على ثبات بعض المستحضرات الصيدليه للمضادات الحيويه تحت ظروف التخزين المختلفه فى مصر | Authors | Nagwa Ali Mohamed Sabri | Issue Date | 2001 |
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