Formulation and evaluation of effervescent tablets.pptx

Effervescent tablets

1. Formulation and Evaluation of Effervescent Tablet Presented by- Parimal Hadge PE/2019/311 S ub-; PE-640

2. Contents 1/28/2021 2

3. Effervescent tablets As per revised definition proposed to US FDA, Effervescent tablet is a tablet intended to be dissolved or dispersed in water before administration. Effervescent tablets are uncoated tablets that generally contain acid substances and carbonates or bicarbonates and which react rapidly in the presence of water by releasing carbon dioxide. They are intended to be dissolved or dispersed in water before use . 1/28/2021 3 Introduction

4. INTRODUCTION Active Ingredients 1. Drugs difficult to digest or disruptive to the stomach 2.pH-sensitive drugs such as amino acid and antibiotics 3. Drug requiring large dose 1/28/2021 4 • Arthritis, inflammation and pain management • Ulcers and gastrointestinal • Allergies • Osteoporosis :

5. 1/28/2021 5 • Acetylsalicylic acid (Aspirin) • Paracetamol (Acetaminophen) • Ibuprofen • Antacid preparations • Ascorbic acid and other Vitamins • Acetylcysteine , a mycolytic agent used as an antidote for paracetamol overdosage . • Activated charcoal preparations used in the management of theophylline poisoning Drugs and drug compositions used as effervescent products

6. Advantages Of Effervescent Tablets 1.Fast onset of action 2.No need to swallow tablets 3.Good stomach and intestinal tolerance 4.Improved palatability 5. Superior stability 6. More consistent response 7. Incorporation of large amounts of active ingredients 8. Accurate dosing 9. Improved therapeutic effect 1/28/2021 6

7. Preparation of Effervescent tablets RAW MATERIALS The effervescent tablet mainly consists of three components: • Active ingredient; • Acid source; • Alkaline compound, constituted by a carbonate or bicarbonate 1/28/2021 7 Acid Sources Three main acid sources are food acids (naturally occurring), acid anhydrides and acid salts. Food acids 1] Citric acid 2] Tartaric acid 3] Ascorbic acid

8. 1/28/2021 8 Acid Anhydrides Citric anhydride and succinic anhydride Glutamic acid Acid Salts 1] Sodium dihydrogen phospate (monosodium phospate ) 2] Disodium dihydrogen pyrophospate (sodium acid pyrophospate ) 3] Acid citrate salts 4] Amino acid hydrochlorides 5] Sodium acid sulphite

9. 1/28/2021 9 Carbonate Sources 1] Sodium bicarbonate 2] Sodium carbonate 3] Potassium bicarbonate and potassium carbonate 4] Sodium sesquicarbonate 5] Sodium glycine carbonate 6] l-lysine carbonate 7] Arginine carbonate 8] Amorphous calcium carbonate 9] Calcium carbonate

10. Formulation Ingredients 1. Diluents : lactose, mannitol, sorbitol or mixtures thereof and spray-dried lactose 2. Binders : Polyvinyl pyrrolidone, maltilol was also found to be a suitable binder for vitamin C 3. Disintegrants : Dextrose and / or sucrose 4 . Lubricants : Stearic acid 5 . Glidants ; Talc, magnesium stearate 6 . Antiadherants : poly tetra-fluoroethylene, polyurethane, 7 . Sweeteners : sucrose, lactose, xylitol , D-glucose, sorbitol or mannitol 8 . Flavors : orange, lemon, pineapple 9 . Colors ; carotenoids and chlorophyll 10. Surfactants; Benzalkaonium chloride, alkyl ether phosphates 11 . Antifoaming Agents : polydimethyl siloxane 1/28/2021 10

11. MANUFACTURING Wet Granulation Method With Heat ( release of water from hydrated formulation ingredients at a low temperature to form the workable mass. With Reactive Liquids ( Ethanol , Isopropanol ) With Non-reactive Liquids ( addition of small amount of water ) Dry Granulation Methods Slugging ( large tablets are compressed using heavy-duty tablet-compacting equipment ) Direct compression ( Dry granulation can be accomplished with the use of special processing equipment known as a roller compactor or chilsonator .) 1/28/2021 11 Methods For Manufacturing

12. EVALUATION Evaluation parameters for effervescent tablets. •Disintegration Time/Effervescent Time •Dissolution Time •Weight Variation •Content Uniformity Other parameters considered by various scientists include • Crushing Strength/Hardness • Friability • Water content & Moisture Uptake Studies • pH of the solution • Organoleptic properties 1/28/2021 12

13. 1.Disintegration Time/Effervescent Time Tablets were placed in each of the six tubes of disintegration apparatus. Use water as immersion fluid, temperature 25 ± 2˚ c was taken . Complete disintegration was noted , if tablet take more than 3 minutes to disintegrate it fails the test. 2.Dissolution Test USP TYPE 2 Apparatus is used 25 ± 2˚ c temperature was maintained at 6.8 pH phosphate buffer, at 50 RPM speed is used. Detection carried out using Spectrophotometer . 3.Weight variation Test Twenty tablets were weighed individually and the average weight was calculated. The individual weight were then compared with the average weight. The tablet will pass the test if not more than two tablets fall inside the percentage limit and none of tablet differ by more than double percentage limit 4. Content Uniformity After crushing 3 tablets take accurately 25 mg of powder of tablet. Subsequently dissolve it in methanol stock solution is prepared and detection of samples is carried out using spectrophotometer at lambda max. 1/28/2021 13

14. 1.Hardness test Using Hardness tester it is carried out. 2. Friability Test A total of 20 tablets were weighed and placed in the Friabilator and then operated at 25 RPM for 4 minutes. The tablets were then weighed again. The difference in the two weights was used to calculate friability.( less than 1 % ) 3. Water content A total of 10 tablets of each formulation were weighed before and after placing in a desiccator containing activated silica gel for 4 h. The percentage of their water content was calculated from the following equation. 4.pH of Solution One tablet was dissolved in purified water. After complete dissolution, the solution pH was measured by a pH meter ( Metrohm , 632, Switzerland). This test was repeated 3 times for each formulation 1/28/2021 14

15. References 1 .European Pharmacopeia. 5  th  ed. Strasbourg Cedex, France: Council of Europe; 2007. p. 749, 1193. 1/28/2021 15 2. Palanisamy P, Abhishehn R, Yoganand KD. Formulation and evaluation of effervescent tablets of aceclofenac . Inter Res J Pharmacol 2011;2:185-90.   3. Lachman L, Liberman HA, Kaning JL. The theory and practice of industrial pharmacy. 3  rd  ed. Philadelphia: Lea and Febiger ; 1987. p. 334-410.   

16. Thank you 1/28/2021 16