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Compatibility between active components of a commercial drug
Fabrizio Rodante1, Stefano Vecchio, Giovanni Catalani
1Department I.C.M.M.P.M., University of Rome La Sapienza, Italy. fabrizio.rodante@uniroma1.it
Farmaco (Societa Chimica Italiana : 1989)
|November 8, 2002
Summary
This study analyzed the thermal stability of diamplicil, an antibiotic combination. Dicloxacillin (D) was found to decrease the kinetic stability of ampicillin (A), while magnesium stearate had no effect.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Chemical Kinetics
Background:
- Diamplicil is a commercial drug combining ampicillin (A) and dicloxacillin (D).
- Understanding the thermal stability of pharmaceutical formulations is crucial for drug efficacy and safety.
- Excipients like magnesium stearate can influence drug stability.
Purpose of the Study:
- To determine the thermal stability of diamplicil.
- To investigate the kinetic decomposition processes of ampicillin and dicloxacillin within the commercial drug.
- To assess the impact of magnesium stearate on the stability of the active components.
Main Methods:
- Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TG) were employed.
- Isothermal and dynamic TG curves were used for kinetic studies.
- Non-isothermal isoconversional methods were applied to analyze kinetic data.
Main Results:
- The thermal stability of diamplicil was analyzed and compared to its active components and magnesium stearate.
- Dicloxacillin (D) was found to reduce the kinetic stability of ampicillin (A).
- Magnesium stearate (M) did not negatively impact the stability of ampicillin or dicloxacillin.
Conclusions:
- The study provides insights into the thermal decomposition of diamplicil.
- Dicloxacillin's presence negatively affects ampicillin's kinetic stability.
- Magnesium stearate is a stable excipient in this formulation, not compromising the active components' stability.