Accelerated stability studies
BP407P Physical Pharmaceutics II Practical
To determine the shelf-life of the product. If stored at 25 C from the given data.
- A pharmaceutical product needs to be physically, chemically, therapeutically, toxicologically and microbiologically stable throughout its shelf-life. The pharmaceutical companies do stability testing for estimating the shelf-life and based on this the expiry date is given for the product.
- The real-time studies at recommended conditions are ideal methods for predicting shelf- life often the studies are designed to increase the rate of chemical degradation or physical change of pharmaceutical products by using exaggerated storage conditions. This is known as accelerated stability testing. The pharmaceutical products are subjected to higher temperature and humidity conditions for accelerating the degradation. However, the results of accelerated testing are not always predictive of physical changes and potency.
- The pharmacopoeia specifies certain storage conditions. The following table gives the details as specified in Indian pharmacopoeia.
Though the medicinal products need to be physically, chemically, therapeutically, toxicologically and microbiologically stable. The chemical instability is most often the main consideration for determining the shelf-life or expiry date. The medicinal products are stored at higher temperature conditions to accelerate the degradation rate. This is known as accelerated stability testing. The rate of chemical reaction increases by 2-3 folds for every rises in 10 C at room temperature. The Arrhenius equation plot (log k vs 1/t) from the equation
Logk= logA –K/2.303 RT
K= rate constant
R= gas constant
T= absolute temperature
E= energy of activation is used to find out the reaction rate constant at 25 C.
- The order of drug decomposition reaction is determined first by plotting the curve. Percent potency retained VS time. Here it is first order
- The k value is determined for each temperature curve.
- The Arrhenius plot is drawn log k vs 1/t
- The value at the desired temperature is determined by extrapolating the Arrhenius equation
- The value of k is placed in the first-order rate equation and is calculated. Three drug products were kept at 4 C ± 2 C/ 75% RH ± 5% RH
The shelf-life of the medicinal product is Product-I K=
Product-II K= Product –III K=
The best product is=
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- Determination of bulk density, true density and porosity
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- Determination of viscosity of semisolid by using Brookfield viscometer
- Determination of reaction rate constant first order.
- Determination of reaction rate constant second order
- Accelerated stability studies
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