May 30, 2024

Accelerated stability studies

Accelerated stability studies

BP407P Physical Pharmaceutics II Practical

Aim:

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.

Principle:

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

Where,
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.

Procedure:

  • 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

REPORT:

The shelf-life of the medicinal product is Product-I K=
Product-II K= Product –III K=
The best product is=


Physical Pharmaceutics II Practical

  1. Determination of particle size, and particle size distribution using the sieving method
  2. Determination of particle size, and particle size distribution using the Microscopic method
  3. Determination of bulk density, true density and porosity
  4. Determine the angle of repose and the influence of lubricant on the angle of repose
  5. Determination of viscosity of liquid using Ostwald’s viscometer
  6. Determination of sedimentation volume with the effect of different suspending agent
  7. Determination of sedimentation volume with the effect of different concentrations of single suspending agent
  8. Determination of viscosity of semisolid by using Brookfield viscometer
  9. Determination of reaction rate constant first order.
  10. Determination of reaction rate constant second order
  11. Accelerated stability studies

Second Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise

S Y B Pharm Sem IIIS Y B Pharm Sem IV
BP301T Pharmaceutical Organic Chemistry II TheoryBP401T Pharmaceutical Organic Chemistry III Theory
BP302T Physical Pharmaceutics I TheoryBP402T Medicinal Chemistry I Theory
BP303T Pharmaceutical Microbiology TheoBP403T Physical Pharmaceutics II Theory
BP304T Pharmaceutical Engineering TheoryBP404T Pharmacology I Theory
BP305P Pharmaceutical Organic Chemistry II PracticalBP405T Pharmacognosy I Theory
BP306P Physical Pharmaceutics I PracticalBP406P Medicinal Chemistry I Practical
BP307P Pharmaceutical Microbiology PracticalBP407P Physical Pharmaceutics II Practical
BP308P Pharmaceutical Engineering PracticalBP408P Pharmacology I Practical
BP409P Pharmacognosy I Practical

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