Granulacion trainning basico

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En este documento se describe los aspectos basicos del proceso de garnualcion farmaceutica asi como una breve descripcion de cada una de ella

En este documento se describe los aspectos basicos del proceso de garnualcion farmaceutica asi como una breve descripcion de cada una de ella

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  • 1. Presentation Granulating with Mike Tousey “There is no replacement for experience” experience” Copyright© Techceuticals~2008 1 Objective Common methods of granule formation for tablet compression. This session will provide a comprehensive, yet simple explanation of typical granulation methods used for pharmaceutical and nutritional products for the purpose of tablet manufacturing. The participant will gain an understanding of methods of granulating and equipment typically used in today's manufacturing environments 2 1
  • 2. The Tablet The Tablet is the final report card for how well all previous operations performed within the process. Keep this objective in mind. There are many really good process operators that never really understand their role is to make a good tablet, not just to complete a function on a machine. 3 Six Reasons to Granulate There are six key reasons to granulate! All six are based on the need to tablet or encapsulate a product. These six “reasons” are the key to improving and optimization of an existing blend or of individual ingredients. 4 2
  • 3. 1.To Improve Flow Powder flow is important throughout the entire tablet making process. Weighing/Batching - accuracy Milling- consistency Blending- content uniformity Granulating - repeatability Tablet Compression – to meet the objectives Flow performance is relative to speed and capacity of the equipment 5 2. Compressibility Tablet Press speeds vary from 48 tablets per minute to over 15,000 tablets per minute. The average press runs at 3000 tpm or 50 tablets per second. The ability for a powder to compress quickly is imperative. The Press knows Weight, Thickness, Speed…Hardness is a result. 6 3
  • 4. 3. Fines & Control Dust Fine particles & dust are often the main cause of poor flow, poor compression, cross contamination, and poor content uniformity. Tablet compression and capsule filling machines perform best with a particle size distribution within a range of 40-200 mesh 7 Particle Size Distribution 70 60 50 40 30 20 10 0 8 4
  • 5. Fines Large Particles Intermediates Fines <20 Mesh 40-120 Mesh >200 Mesh 850 μm/.0331” 425-125 μm 75 μm/.0029” 10-20% .0165”-.0049” 10-20% 70-80% 9 4. Control Segregation Segregation means that powders are not staying mixed and are separating. This leads to content uniformity issues and table weight & hardness control. 10 5
  • 6. 5. Density Control Density variation within a single ingredient equates to major problems with tablet & capsule manufacturing across the board. Bulk density variation Each item in the above photo weighs of ingredients within the same! the blend is a recipe for trouble. 11 6. Capture & fuse “Active” There are 2 things “Actives and Excipients” within a formulation. Sometimes we granulate the entire blend and other times we granulate individual ingredients. The Active Ingredient can represent a very small percentage of the final formulation or a very high percentage of the formulation. 12 6
  • 7. Which Pathway? Direct Compression Wet Granulating Dry Granulating 13 Direct Compression Why not just weigh the powder, mix it and put it on the tablet press? 14 7
  • 8. Granule Formation Granules can be formed by adding a liquid “Binder “ into the dry powder mass, much like combining water, milk or egg with flour when cooking. Granules can be formed through dry compaction; compaction; some powders are sensitive to liquid addition and high temperatures from the drying process. 15 What is a Binder? A binder is an “excipient” (non-active ingredient) that forms a bridge and locks particles together…aka a pharmaceutical glue. There are dry binders and wet Binders and there are a few binders like “Avicel PH102” by FMC that can work as a dry or wet binder 16 8
  • 9. Wet Granulating Pre-Blend Wet Mass Mill Dry Mill Final Blend 17 Dry Granulating Dry Granulating is also known as Roller Compaction and Slugging 18 9
  • 10. Process Pathways Wet Granulation Dry Granulation Direct Blending Pre-mix Pre-mix Wet Massing Slugging/Chilsonating Drying Milling Milling Final Blending Charge and Blend Powde rs Final Blending 19 5 Steps There are 5 steps to follow which will help to Determine if granulating is necessary 20 10
  • 11. 1. Is Direct Compression Feasible? If yes = Direct Compress If no= The product must be Granulated Many products are successful at a slow speed on a tablet press, but not fast. Can your product run as fast as the press can go? If the answer is No, then your product is non-optimized and is limited in some way? 21 2. Is the Blend Cohesive If yes = Direct Compress If no= The product must be Granulated Products need to be cohesive (sticky). If the answer is no something must be added to help lock the particles together. If products are too cohesive then we have another problem which is commonly referred to as “sticking & picking”. 22 11
  • 12. 3. Is the Flow acceptable? If yes = Direct Compress If no= The product must be Granulated Flow is critical and it can change from product variation, environmental changes, and it can be impacted by time. Good flow is like granulated sugar Bad flow is like flour 23 4. Is Content uniformity acceptable? If yes = Direct Compress If no= The product must be Granulated What is “content uniformity”? Content Uniformity means that each and every tablet has the same quantity of ingredients within an acceptable range. Is it possible to blend powders and then have them come unblended? YES. 24 12
  • 13. 5. Is the Bulk Density acceptable? If yes = Direct Compress If no= The product must be Granulated 25 Granulate If the answer to any of the above was YES then the formula or ingredients within the blend must be granulated. Which method of granulation should you choose? Wet or Dry Granulating? 26 13
  • 14. Summary Remember that the purpose of Granulating is to simply make a better tablet. If there is a problem such as weight, hardness, thickness, friability, appearance, disintegration, dissolution, content uniformity, just to name the major ones…then the need to granulate or the need to improve they way you are granulating must be carried out. 27 Granulating series Granulating Basics 101 – Dec 4th Granulating 201 – Feb 26th Granulating 301- April 23rd If you would like to attend future Granulating programs please email a request for a discount coupon after this presentation and we will email a 10% discount coupon good for future sessions. 28 14
  • 15. Special Request Please send photos and examples of defects or examples of common problems at your facility. In return we will send you a free pass to a future seminar. 29 Questions and Thank You! Open for Questions If you don’t get the answer, email or call me to discuss Please join us next week for our QA/QC session Thank You for joining me….Mike Tousey Techceuticals 36 Persimmons Street, Suite 303 Bluffton, South Carolina, USA 29693-4519 Phone: 843 815 7441 Fax: 843 815 7446 E-mail: sales@techceuticals.com Web: www.techceuticals.com 30 15
  • 16. Thank You for attending today! We hope you enjoyed today’s program and will join us again soon. If you need help, let the professionals at Techceuticals bring their practical solutions to your company! Ask us how today! Techceuticals 36 Persimmons Street, Suite 303 Bluffton, South Carolina, USA 29693-4519 Phone: 843 815 7441 Fax: 843 815 7446 E-mail: sales@techceuticals.com Web: www.techceuticals.com 31 16