Dry Powders Parenterals(Reconstitution).pptx

Powders used in injections

1. Dry Powder Parenterals Presented By: Muhammad Haider Ali Roll No: 43

2. Dry Powders Dry Powder formulations are lyophilized or freeze-dried powders that must be reconstituted with some suitable solvent to make a liquid formulation before being withdrawn from the vial. Some drugs are not stable in liquid form and so these drugs are put into the powder form and reconstituted juts prior to use. There are several solvents that might be used to reconstitute the dry powders; the most common solvents are sterile water for injection, bacteriostatic water for injection, sodium chloride injection.

3. Importance: Improved Stability: Dry powder formulations often exhibit better stability compared to their liquid counterparts Extended Shelf Life : Dry powder parenterals, especially those subjected to lyophilization (freeze-drying), have an extended shelf life. Ease of Storage and Transportation : Dry powders are more compact and lightweight than liquid formulations, making them easier to store and transport. Reduced Microbial Contamination Risk : The absence of water in dry powder formulations minimizes the risk of microbial contamination.

4. Types of Dry Powders: Freeze-Dried Powders : Definition: Freeze-drying, or lyophilization, is a process that involves freezing a liquid product and then removing the ice by sublimation under vacuum. The result is a dry, porous structure. Purpose: Freeze-dried powders are known for their improved stability, longer shelf life, and ease of reconstitution, making them suitable for sensitive or unstable drugs. Spray-Dried Powders : Definition: Spray drying is a process where a liquid is atomized into a fine mist and then dried quickly by contact with hot air. The dried particles are collected as a powder. Purpose: Spray-dried powders are often used to improve solubility, enhance stability, and facilitate the production of fine particles for inhalation or reconstitution.

5. Powder for Reconstitution : Definition: Powders designed to be reconstituted with a specific volume of liquid before administration. This is common in injectable medications. Purpose: Facilitates the preparation of a liquid dosage form immediately before administration, ensuring freshness and stability.

6. Formulation Considerations: Stability : Formulators need to consider the physical and chemical stability of the drug in dry powder form. Solubility: Ensuring that the drug can be readily reconstituted and dissolved for administration. Compatibility: Compatibility with other excipients and the packaging material.

7. Examples: Ampicillin: The drug is used to prevent and treat a number of bacterial infections, such as respiratory tract infections, urinary tract infections. Tazobactum: Tazobactam is an antibiotic of the beta-lactamase inhibitor class. Esmazole: used in the treatment of gastroesophageal reflux disease and peptic ulcer disease.

8. QC Tests for Parenterals: There are mainly five quality control test for the parenterals are performed; Leaker Test (Bubble test, Dye test) Clarity Test Pyrogen Test Sterility Test Content Uniformity Test