Preparation #2.pptx

Effervescent Granules

1. Preparation #2 Effervescent Granules Compiled by: Ivy Rose C. Orozco,RPh PHARMACEUTICS1L – Pharmaceutical Dosage Forms, Drug Delivery Systems and Medical Devices

2. Determine the different methods of preparing granules Differentiate the methods of preparing granules Identify the rationale behind the composition of effervescent granules Objectives

3. Granules Composed of dry aggregates of powder particles that may containe 1 or more API, with or without other ingredients

4. Effervescent Granules Coarse to very coarse powders containing medicinal agent in a mixture

5. Methods of Preparation of Granules Wet and Dry Granulation

6. Particle Size Analysis Measure the sizes of grains Why measure?

7. USP Standards for Powders of Animals and Vegetable Drugs Description Sieve size Sieve size percentage Very coarse No. 8 All particles pass through Sieve No. 8, and not more than 80% pass through Sieve No. 60 Coarse No. 20 All particles pass through Sieve No. 20, and not more than 40% pass through Sieve No. 60 Moderately coarse No. 40 All particles pass through Sieve No. 40, and not more than 40% pass through Sieve No. 80 Fine No. 60 All particles pass through Sieve No. 60, and not more than 40% pass through Sieve No. 100 Very Fine No. 80 All particles pass through Sieve No. 80, and no limit to greater fineness

8. USP Standards for Powders of Chemicals

9. Methods of Particle Size Analysis Microscopy Sieving Sedimentation rate Light energy diffraction or light scattering techniques Cascade impaction Laser holography

10. 01 Particles are mechanically passed through different size of sieves (40-9,500 microm.) Sieving 02 Through a microscope and particles are viewed through calibrated grid background (0.2-100 microm.) Microscopy 03 Measuring the terminal settling velocity of particles through a liquid medium in a gravitational or centrifugal environment (0.8-300 microm.) Sedimentation rate 04 Determined by the reduction in light intensity reaching the sensor as the particle, dispersed un a liquid or gas, passes through the sensing zone (0.2-500microm.) Light scattering Methods of Particle Size Analysis

11. Formulation Purified water q.s. To initiate agglomeration Tartaric acid When combined with NaHCO3, aids in the solubility by accelerating it. Citric acid Flavor-enhancer (citrusy) insoluble Sodium bicarbonate Reacts with acids to produce effervescence

12. Formulation Purified water q.s. To initiate agglomeration Tartaric acid When combined with NaHCO3, aids in the solubility by accelerating it. Citric acid Flavor-enhancer (citrusy) insoluble Sodium bicarbonate Reacts with acids to produce effervescence

13. Incorporation of Liquids to Powders Use geometric dilution – increasing quantities Spraying alcohol solution – suitable to high-potency drugs

14. Hygroscopic and Deliquescent powders Hygroscopic – absorb moisture from the air Deliquescent – absorb moisture from the air to the extent that they will partially or wholly liquify

15. Hygroscopic and Deliquescent powders Dispense the ingredients in a tightly closed containers, add dessicant packet Instruct the patient to store it in a dry place and close container tightly

16. Eutectic mixture Powders liquify when mixed together. To keep the preparation dry, it should be mixed with a bulky powder (adsorbent) Triturated lightly on a pill tile using spatula

17. Examples of Commercially available Granules

18. End of Discussion