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(Mups) novel pellets for oral dosage forms

novel pellets for oral dosage forms

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(Mups) novel pellets for oral dosage forms

  1. 1. This Presentation is submitted to BCDA COLLEGE OF PHARMACY AND TECHNOLOGY Under the guidance of Mr. Seemanchala Rath, Assistant Professor M. Pharm. (Utkal Univ.) By Nilanjan Bhattacharya B. Pharm. 7th Sem. University Roll No. - 20101911022 & Prosenjit Chakraborty B. Pharm. 7th Sem. University Roll No. - 20101911026 1
  2. 2.  Pelletization can be defined as an agglomeration (size-enlargement) process that converts fine powders or particles of bulk drugs and excipients into small, free-flowing, spherical units called pellets.  Pellets size ranges from 0.5 to 2.0 mm, having free- flowing properties and a low porosity of about 10 %.  The term “spheronization” implies spherical units formed by a size-enlargement process that includes a spheronization step where extrudates or agglomerates are rounded as they tumble on a rotating frictional base plate, being named “spheroids”. 2
  3. 3.  Spherical shape and smooth surface is considered as desired characteristics for uniform film coating.  The particle size of pellets should be in range of 0.5 to 2.0 mm.  The quantity of the active ingredient in pellets should be maximum in order to maintain size of pellet. 3
  4. 4.  They can be divided in to desired dosage strength without process or formulation changes.  They can be blended to deliver incompatible bioactive agents.  They can be used to provide different release profile at the same or different sites in the gastrointestinal tract.  When pellets containing the active ingredient are in the form of suspension, capsules, or disintegrating tablets, they offer significant therapeutic advantages over single unit dosage forms. 4
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  6. 6.  Agitation can be further classified under Balling, which is –  A technique is not popular in the pharmaceutical industry as a Pelletization process.  This is because due to the constraints of particle size distribution and content uniformity.  Work in this area is expected to continue. 6
  7. 7.  Compaction is a form of pressure agglomeration, in which drug particles or granules are forced together with or without formulation aids by a mechanical force to generate pellets of well defined shapes and sizes.  The Pelletization process can be subdivided into compression and extrusion. 7
  8. 8.  In this process, drug is layered onto seed materials (generally, a coarse material) in powder, solution or suspension form and leads to heterogeneous pellets, which consist of an inner core region and an outer shell region of a different composition. This process is classified into three categories namely : 1. Direct Pelletization 2. Solution or Suspension Layering 3. Powder Layering 8
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  12. 12.  It is a process where hot melts, solutions, or suspensions are atomized to generate spherical particles or pellets.  In globulation, atomization produces solid particles directly from the liquid phase through evaporation or cooling and subsequent solidification of hot melts, solution and suspension. 12
  13. 13. It is an approach that has come into existence which combines the features of both controlled release tablets and modified release capsules in one dosage form, such a system is known as MUPS tablets or Multiple-Unit Pellet System. 13
  14. 14. When taken orally, multiple unit dosage forms-  Disperse freely in the gastro intestinal tract.  Offer reduced variation in gastric emptying rate and transit time which is less dependent on the state of nutrition.  Reduces localized concentration of irritative drugs.  Improves safety and efficacy of a drug. 14
  15. 15.  Should maintain all the tablet properties.  Pellets should not show any interaction like developing electrostatic charges during compression.  The drug release should not be affected by the compaction process.  Like tablets, MUPS should have ease to withstand physical parameters, stability, packing storage and transportation.  The dosage form must disintegrate rapidly into individual pellets in gastrointestinal fluids. 15
  16. 16. MUPS formulations are broadly classified into two types : A. MUPS with matrix pellets B. MUPS with pellets coated 16
  17. 17.  Pellets which inherently contain excipients that slows down the drug release by being contained within the matrix of pellet structure commonly referred as MUPS with matrix pellets .  For example matrix pellets of swellable polymers or waxes, retain their controlled release characteristics to a larger extent.  Fusion of matrix pellets as a result of compaction can be avoided by application of film coating or by excessive blending with a hydrophobic agent. 17
  18. 18. There are several types of coating, they are followed by : 18
  19. 19. PRODUCT COMPANY DRUG THERAPUTIC CATEGORY FORMULATIO N TYPE Losec MUPS Astra Zeneca Omeprazole magnesium Antiulcer Antiulcer Esomeprazole Astra Zeneca Esomepraz ole magnesium Antiulcer Antiulcer Toprol XL Astra Zeneca Metoprolol tartrate Antihypertensi ve Extended release Prevacid SoluTab Takeda Lansoprazo le Antiulcer Delayed release orodispersible tablet Theodur key Theophyllin e Antihistaminic Extended release 19
  20. 20. Thus we see that the present scenario of MUPS find a greater advantage due to its flexible design in variable release properties, stability, patient compliance and economic compared to other dosage forms. For the pharmaceutical industry, not only the innovation of new products and techniques, creation of line extension, expansion of patent protection, achieving globalized product and thereby overcome competition are also key strategies with respect to profit perspective. MUPS meet all these with medical, health care, and business benefits. 20
  21. 21. Reddy S ,Das P, Das H, Das, Ghosh A, MUPS (Multiple Unit Pellet System) Tablets – A Brief Review, JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL SCIENCES, 2011, Vol 12 (02) N.Jawahar, Patel H.A, Multi Unit Particulates Systems (MUPS): A Novel Pellets for Oral Dosage Forms Journal Of Pharmaceutical Science and Research, 2012,Vol.4(9) S.Ramu*, G.Ramakrishna, M.Balaji, Rao K.K, Reddy S.H, Kumar D.P, Multiple Unit Drug Delivery System: Pelletization Techniques, American Journal of Advanced DrugDelivery,2013,Vol: 1[1] Hirjau M, Nicoara A.C, Hirjau V, Lupuleasa D, PELLETIZATION TECHNIQUES USED IN PHARMACEUTICAL FIELDS. Practica Farmaceutică, 2011, Vol. 4 VR Sirisha K, K Vijaya sri, K Suresh, G Kamalakar Reddy, MULTIPLE UNIT PELLET SYSTEMS: A REVIEW , Int J Pharm 2012; 2(2) 21
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