A presentation on Hard Gelatin Capsule

A presentation on Hard Gelatin Capsule. capsule manufacturing

1. A presentation on Hard Gelatin Capsule Group C Submitted by : 20150109002 20151209008 20150109016 20150109017 20151209030 20151209036 20150109039 20151209040 20141209004 20140109013 Submitted to: Shanita Zaman Smritiy Lecturer Dept. of Pharmacy BSMRSTU

2. CONTENTS: Introduction Parts of capsule Types of capsule Hard gelatin capsule Ingredients of hard gelatin capsule Size of capsule Criteria of HGC Difference between HGC & SGC Formulation of gelatin Manufacture of empty capsule shell

3. CONTENTS: Capsule shell filling Advantage of HGC Disadvantage of HGC Problems and remedies Evaluation of capsule Conclusion

4. Introduction: Capsule are solid preparation with hard and soft shells of various shapes and capacities, usually containing a single dose of active ingredients. Examples :Omeprazole capsule, Ampicillin capsule

5. Parts of capsule: Cap Body

6. Types of capsule

7. Hard gelatin capsule: Contain 12-16 % moisture Typically filled with dry solid powders granules pellets tablets Also contain colorant preservatives

8. Ingredients for hard gelatin capsule: Active ingredient . Gelatin Preservatives Colorant Plasticizer Filler Water

9. Size of capsule: Size Volume in ml Size in mm 000 1.37 26.3 00 0.95 23.7 0.68 21.8 1 0.50 19.2 2 0.37 18.3 3 0.30 15.3 4 0.21 14.7

10. Criteria of hard gelatin capsule: Hard gelatin capsule should be less brittle It should be good for hygroscopic formulations It should be good for moisture-sensitive ingredients Normally hard gelatin capsules contain between 13 to 16 % of moisture Should be insoluble in cold water HGC allow a degree of flexibility of formulation that are not obtainable with tablets

11. Difference between HGC and SGC: Features Hard gelatin capsule Soft gelatin capsule 1.Filling materials 1.Solid or granular fill 1.Semi solid ,liquid or solid Fill. 2.Shape 2.Cylindrical in shape 2.Round,oval or tube like shape 3.Formulation materials 3.Contains gelatin, titanium oxide coloring agents and Plasticizers. 3.Contains gelatin, plasticizer, preservative, coloring agents ,sugar and flavoring agent 4.Ratio of the gelatin and plasticizer 4.Ratio is 0.4:1 4.Ratio is 0.8:1 5.Structure 5.Cap and body 5.Body 6.Preservative 6.Low amount of preservative .High amount of preservative 7.Capacity 7.30 to 600 mg 7.0.1-30ml

12. Formulation of gelatin : Gelatin: it is prepared by the hydrolysis of collagen obtained from animal connective tissue, bone and pork skin. There are two types of gelatin 1. Type A (Acid hydrolysis of pork skin) 2. Type B (Alkaline hydrolysis of bones)

13. Manufacture of empty capsule shell 1. Dipping 2. Spinning 3. Drying 4. Stripping 5. Trimming and Joining 6. Polishing

14. Capsule shell filling: 1.Filling of powder formulation: a. bench – scale filling b. industrial scale filling 2. Pellet filling 3. Tablet filling 4. Semi-solid and liquid filling

15. Advantages of HGC: Easy to shallow Masking capacity Protection of medicament Therapeutically inert and easy to digest Easy to handle and carry Different sizes are available Product identification Provide enteric and sustained release effects

16. Disadvantages of HGC: Hydroscopic drug is not suitable for filling into the capsule . chloride are sudden release such compound in the stomach cause irritation. Efflorescent substance may cause to capsule too soft. Deliquescent material may dry to the capsule shell to excessive.

17. Problems and Remedies of HGC: 1. Hygroscopic powders Remedy :Adsorbent such as ;Magnesium carbonate ,Magnesium Oxide 2. Eutectic mixture Remedy : Use of adsorbent 3.Small dose of drug Remedy : Addition of inert powder 4.Lack of adhesiveness difficult to fill by punch method Remedy : Moistened with alcohol ,granules reduced to powders

18. Evaluation of capsule 1.Disintregration time 2.Drug contents 3.Weight variation

19. 1. Disintegration Time: One capsule was placed in each of six tubes of assembly and assembly was suspended in water. Discs were added to each tube, temperature was maintained at 37±2°C and assembly was operated for 60 min . 2. Drug Content : Weigh an amount of the granules equivalent to 50 mg of losartan potassium was dissolved in 100 ml of phosphate buffer pH 6.8, filtered, diluted suitably and analyzed for the drug content at 246 nm using UV-visible spectrophotometer . 3. Weight variation: 20 capsules are individually weighed, average weight and percentage deviation limits are average weight ±10%. If the weight variations are beyond the limit, net weights are determined, the net weights of the not more than 2 capsules should fall outside the average net weight ±10% values and net weight of no capsule should be outside the average net weight ±25% limit.

20. Conclusion Capsule are more advantageous than the other dosage forms .Hard gelatin capsule is more versatile over the world .

21. Thanks to all