seminar lecture storage conditions-1.pptx

storage condition

1. STORAGE CONDITIONS OF PHARMACEUTICALS

2. INTRODUCTION Proper storage of drugs is crucial to maintain their efficacy, safety, and shelf-life. Incorrect storage can lead to degradation, reduced effectiveness, and potential harm to patients.

3. IMPORTANCE OF PROPER STORAGE CONDITIONS Maintaining drug efficacy and safety Preventing degradation and contamination Ensuring compliance with regulatory standards

4. To mimimize adverse effects Prevent toxicity Chemical stability Ensuring therapeutic effectiveness

5. STORAGE GUIDELINES The storage conditions for drugs and injections vary based on their chemical stability and formulation. Here are some general guidelines: TEMPERATURE HUMIDITY LIGHT SENSITIVITY AIR EXPOSURE

6. TEMPERATURE Many drugs are sensitive to temperature fluctuations. High temperatures can accelerate the degradation of active ingredients, reducing the drug’s efficacy. Low temperatures can cause some medications to crystallize or seperate.

7. TEMPERATURE Room t emperature: Range: ( 15°C to 30°C ) Examples: many oral medications such as tablets and capsules Considerstions: Avoid storing medications in places where temperature can flunctuate significantly such as near heat sources

8. TEMPERATURE CONT REFRIGERATION Range: 2°C to 8°C Examples: insulin, oxytocin,ergometrine consideratons: ensure steady power supply to the refrigerator to avoid temperature flunctuations

9. HUMIDITY CONTTROL Inappropriate moisture levels in the pharmaceutical store can result in reduced product quality and shortened shelf life. On top of that, it can deteriorate the product making it ineffective, or worse, unsafe for use.

10. LIGHT SENSITIVITY Exposure to light, especially UV light, can cause chemical reactions in some medications, leading to degradation of active ingredients. This degradation can reduce the drug’s potency, making it less effective or even ineffective.

11. LIGHT SENSITIVITY Examples: Antibiotics like ciprofloxacin, doxycycline. Considerations: Store in amber or opaque containers to prevent degradation from light exposure.

12. AIR EXPOSURE Oxidation: Chemical Degradation: Oxygen in the air can cause oxidation of active pharmaceutical ingredients, leading to the degradation of the drug. This reduces the drug’s potency and can render it ineffective.

13. Microbial Contamination: Contamination Risk: Exposure to air can introduce microbial contaminants, which can spoil the medication or cause infections if administered. This is particularly a concern for sterile products like injections and eye drops.

14. AIR EXPOSURE Air Exposure Airtight containers: Some medications like effervescent tablets or those prone to oxidation need to be kept in airtight containers.

15. BEST PRACTICES FOR STORAGE Use of climate-controlled storage facilities Regular monitoring and logging of temperature and humidity Proper labeling and dating of products Training staff on storage protocols

16. Consequences of Improper Storage Reduced efficacy of medications Potential harm to patients Regulatory non-compliance and legal issues

17. Improper storage can lead to the formation of toxic degradation products. For example, certain antibiotics can become harmful if they degrade due to improper temperature control. Improper storage can lead to loss of expensive drugs and biologics

18. Improperly stored medications can lead to reduced effectiveness or unexpected side effects, negatively impacting patient outcomes. Some drugs, especially those requiring sterile conditions, must be stored at specific temperatures to prevent microbial growth.

19. CONCLUSION Proper storage of drugs is critical for maintaining their efficacy, safety, and integrity. Understanding and adhering to specific storage conditions ensures that medications remain effective and safe for patient use.

20. REFRENCES 1. U.S. Pharmacopeia (USP): • USP General Chapter <659> Packaging and Storage Requirements: • URL: USP <659> • USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations:

21. URL: USP <797> 2. World Health Organization (WHO): • WHO Guidelines on the Stability of Pharmaceuticals: • URL: WHO • URL: WHO Stability Guidelines • URL: WHO Technical Report Series, No. 961

22. . FDA Guidance for Industry: • FDA Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics: • URL: FDA Container Closure Guidance • FDA Guidance for Industry: Stability Testing of New Drug Substances and Products: • URL: FDA Stability Testing Guidance