#Kuliah : Stabilitas Obat : Secara Fisika, Kimia, Biologi

Updated: December 24, 2024

Abdul Wafi


Summary

The video discusses the crucial factors contributing to drug stability during storage, emphasizing the prevention of degradation in pharmaceutical products. It highlights the significance of understanding degradation processes like hydrolysis, oxidation, and photolysis, which can affect drug stability. The importance of conducting various stability tests such as physical, chemical, and microbiological to ensure the efficacy and safety of pharmaceuticals is also explained. Factors like temperature, light exposure, and moisture are identified as key influencers of drug stability, and different testing methods like real-time and accelerated stability testing are discussed for assessing drug stability over time.


Introduction and Importance of Drug Stability

Discussion on the factors influencing the stability of drugs during storage and prevention of degradation.

Definition of Drug Stability

Explaining the ability of a drug to remain unchanged within a specific time frame and storage conditions.

Significance of Drug Stability

Importance of drug stability in pharmaceuticals to prevent degradation of active ingredients, loss of concentration, color changes, and homogeneity.

Types of Stability Testing

Overview of three main types of stability testing: physical stability, chemical stability, and microbiological stability.

Degradation Processes

Explanation of degradation processes such as hydrolysis, oxidation, photolysis, and solvolysis, and their effects on drug stability.

Factors affecting Drug Stability

Factors like temperature, light exposure, moisture, oxygen content, and microbial contamination affecting drug stability and methods to address them.

Stability Testing Methods

Discussion on real-time stability testing, accelerated stability testing, and factors influencing the choice of testing conditions for pharmaceutical products.


FAQ

Q: What are the factors influencing the stability of drugs during storage?

A: Factors influencing drug stability during storage include temperature, light exposure, moisture, oxygen content, and microbial contamination.

Q: What is the importance of drug stability in pharmaceuticals?

A: Drug stability in pharmaceuticals is crucial to prevent degradation of active ingredients, loss of concentration, color changes, and ensure homogeneity of the drug product.

Q: What are the three main types of stability testing mentioned in the file?

A: The three main types of stability testing are physical stability, chemical stability, and microbiological stability.

Q: Can you explain the degradation processes that affect drug stability?

A: Degradation processes that affect drug stability include hydrolysis, oxidation, photolysis, and solvolysis.

Q: What are some methods to address factors that affect drug stability?

A: Methods to address factors affecting drug stability include proper temperature control, protection from light exposure, moisture barriers, oxygen scavengers, and microbial contamination prevention.

Q: What are real-time stability testing and accelerated stability testing?

A: Real-time stability testing involves monitoring the drug over an extended period under normal storage conditions, while accelerated stability testing uses exaggerated conditions to predict long-term stability in a shorter time.

Q: How do factors influence the choice of testing conditions for pharmaceutical products?

A: Factors such as the intended storage environment of the drug product, expected shelf life, and regulatory requirements influence the choice of testing conditions for pharmaceutical products.

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