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Troubleshooting Of Compression Issues with Complete Solution.pptx
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Troubleshooting Of Compression Issues with Complete Solution.pptx
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Troubleshooting Of Compression Issues with Complete Solution
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Troubleshooting Of Compression Issues with Complete Solution.pptx
1.
Copyright © Keva
Pharmaceuticals TROUBLESHOOTING OF COMPRESSION ISSUES Presenter: Suraj Kumar Sah 25th July , 2023 Keva Pharmaceuticals Pvt. Ltd., Ratnanagar-16, Chitwan 1
2.
Copyright © Keva
Pharmaceuticals Before We Start What is Compression? Compression Machines at Keva Pharmaceuticals… Factors affecting compression… Problems faced during compression… Impacts of compression… 2
3.
Copyright © Keva
Pharmaceuticals Outline 1.Introduction 2.Factor affecting compression 3.Problem faced during compression 4.Impact of compression 5.Conclusion 6.References 7.Q & A 3
4.
Copyright © Keva
Pharmaceuticals Introduction Compression: According to USP When we apply any force to powder bed then bulk volume will be reduced, known as Compression. The reduction in the bulk volume of a material as a result of the removal of void space by applied pressure. CONSOLIDATION: Involves an increase in the mechanical strength of a material resulting from particle-particle interactions. COMPACTION: The compression and consolidation of granules due to an applied force, known as Compaction. 4
5.
Copyright © Keva
Pharmaceuticals Factor Affecting Compression Surface Properties Porosity Flow Properties Compression Force Compression Speed Moisture Content 5
6.
Copyright © Keva
Pharmaceuticals • 1. Capping • 2. Lamination • 3. Cracking • 4. Chipping • 5. Sticking • 6. Picking • 7. Mottling • 8. Double Impression • 9. Weight Variation • 10. Hardness Variation • 11. Friability PROBLEM FACED DURING COMPRESSION 6
7.
Copyright © Keva
Pharmaceuticals Capping 7 Causes: Due to the air entrapment during compression. Low moisture in granules. Deep concave punches. Remedies/Solution: Precompression, Reducing the final compression pressure. Dry the granules properly. Use flat punches. Partial or complete separation of top or bottom crown of tablet.
8.
Copyright © Keva
Pharmaceuticals Lamination Separation of a tablet in to two or more distinct horizontal layers. Causes: • Too much compression pressure. • Unwanted dried granules. Remedies: Accurate compression force should be apply to form tablet. Add hygroscopic substances certain % of moisture by e.g. Sorbitol, Methylcellulose, PEG. 8
9.
Copyright © Keva
Pharmaceuticals Cracking • Small, fine cracks observed on the upper and lower central surface of tablets. Reason: Deep concave punches. Too dry granules. Remedies: Using Flat punches. Moisten the granules properly. 9
10.
Copyright © Keva
Pharmaceuticals Chipping • Breaking of tablet edges, while the tablet leaves the press or during subsequent handling. • Reason: Incorrect machine settings/ Less Binder Remedies: • The Causes and Remedies of chipping related to ‘Formulation’ 10 Sr. No. CAUSES REMEDIES 1. Machine RPM too fast Reduce machine speed 2. Too dry granules Increase the moisture content of granules. 3. Scratch/uneven Surface Smooth punch 10
11.
Copyright © Keva
Pharmaceuticals Sticking Sticking is the problem where the material adhere to die wall during tablet compression. Reason: Fig: Sticking on punch Face. Pressure applied is higher. Excessive moisture in granules. Rough die surface. Remedies: Decrease the pressure to optimum. Proper drying of granules. Adding glidant and lubricants. 11
12.
Copyright © Keva
Pharmaceuticals Picking 12 Material adhere to punch faces Picking is the term used when a small amount of material from a tablet is sticking to and being removed off from the tablet surface by a punch face.This occurs predominantly in upper faces of the punches.
13.
Copyright © Keva
Pharmaceuticals Picking CAUSES Excessive moisture in granules Improper lubrication Low melting point substances added Rough or scratched punch faces REMEDIES Drying of granules Increasing lubrication Use high melting point lubricants Platting of punch faces by - Chromium 13
14.
Copyright © Keva
Pharmaceuticals Mottling • Mottling is the term used to describe an unequal distribution of color on a tablet. Causes : • Different colors of excipients or a drug • Migration of dyes to the surface of granules during drying • Improper mixing of color Remedies: • Change the solvent system (binding system) • Reduce the drying temperature • Mix properly and reduce the size to prevent the mottling. 14
15.
Copyright © Keva
Pharmaceuticals Double Impression Due to free rotation of the punches, having some engraving on their faces. Reasons For Double impression: Uncontrolled rotation of either upper punch or lower punch during ejection of a tablet. Solution/Remedies: • Use of keyed punches. • Use of Anti-Turning Devices. 15
16.
Copyright © Keva
Pharmaceuticals Weight Variation The tablets of one particular batch should have uniformity in weight. If any weight variation is found, it should fall within the prescribed limits. Tablet forms with different weight. Causes: Improper feeding of hopper, Poor flow, Lack of glidant and lubricant. Remedies: Add sufficient amount of glidants and lubricants, proper the amount of binder, uniform granules/mixing. 16
17.
Copyright © Keva
Pharmaceuticals Hardness Variation • Tablets having different hardness value. Generally, as granules size increases, tablets are found to show increased weight variation, and same occur with the hardness. Causes : • Improper binder concentration and uniformity. • Room temperature and RH. • Remedies: Ensure proper amount and uniformity of binder. During compression, maintain room temperature and RH. 17
18.
Copyright © Keva
Pharmaceuticals Friability Friability is the tendency of a tablet to crumble or break when subjected to mechanical stress. The causes of high friability include inadequate binder, Improper drying of granules, and tablet hardness. The remedies for high friability include: control of binder, moisture and compression pressure. 18
19.
Copyright © Keva
Pharmaceuticals Conclusion These visual defects can reduce the acceptability by the users and patient compliance of the product. In this slide, defects, causes and measures to overcome these defects have been discussed. The focus of this discussion is to establish ways to resolve common defects during the tablet compression, and to identify the root cause of each. 19
20.
Copyright © Keva
Pharmaceuticals REFRENCES 1.Lachman L., Liberman, H.A., Joseph L. K. The Theory and Practice of Industrial Pharmacy; Varghese Publishing House; Mumbai; Third Edition 297-321. 3.Aulton M. pharmaceutics: The science of Dosage Form Design; International Student Edition: 304-321, 347-668. 4.Remington J. Remington: The Science and Practice of Pharmacy; Nineteenth Edition:Volume Ⅱ 1615-1641. 5. Ansel H., Allen L., Jr. Popovich N. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery System; Eighth Edition:227-259. 6. Mohrle R “Effervescent tablets” in Liberman, Lachman, Lachman L. Schwartz. Pharmaceutical dosage form, “Tablets” vol-Ⅰ first Indian reprint (2005) Marcel dekkar inc New York -285-292. 20
21.
Copyright © Keva
Pharmaceuticals 21
22.
Copyright © Keva
Pharmaceuticals 22