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Multi Unit Pellet System (MUPS)

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Multi Unit Pellet System (MUPS)

  1. 1. Multi Unit Pellet System (MUPS) Presented by- Riteksha Patel M. Pharma (Pharmaceutics) SCOPE
  2. 2. Introduction • The tablets which are prepared by compaction of modified release coated pellets are called as MUPS (multi unit pellet system) tablets. • Pellets are produced for the purpose of oral controlled- release dosage form having gastro resistant or sustained- release properties. • For such purposes, coated pellets are administered in the form of MUPS tablets. The coating material used is either sustained release or enteric release. • Different release profile can be achieved at same time at same site in GIT.
  3. 3. Advantages • They provide different release profile at the same or different sites in GIT. • Local irritation of drug can be avoided. • Incompatible bioactive agents can be delivered simultaneously. • Bitter taste of drug can be masked. • Sustained release, enteric release dosage form can be formulated • Greater bioavailability & uniform drug absorption • Dose dumping and the incomplete drug release is avoided. • Better patient compliance. • MUPS have lesser tendency of adhering to esophagus during swallowing. • Reduction in inter- & intra-subject variability in drug absorption.
  4. 4. Method of Preparation • Preheating of core particle was done. • The drug solution was loaded over core particles & dried. • The drug loaded pellets was sifted through the sieve. • The enteric, sustained, or controlled release polymer was dissolved in a solvent to prepare a coating solution. • This solution was sprayed over drug loaded pellets & dried. • This coated pellets was then compressed along with other excipients to prepare the MUPS tablet.
  5. 5. Types of MUPS Formulation A) MUPS with matrix pellets B) MUPS with pellets coated
  6. 6. . Factors Influencing Design of MUPS Process Variables Equipment Variables Core Pellets Cushioning Excipients Coating Type & Composition Size & Shape Porosity & Elasticity Polymer type Membrane Thickness Plasticizer type & Amount Presence of Pigments Nature Size Amount Compression Force Compression Speed Tablet Machine Design Tooling Design Powder Feeder Design
  7. 7. Marketed Preparations
  8. 8. Pelletization • Preparation of pellets is called pelletization. • Pellets can be defined as small, free flowing, spherical or semi-spherical solid, units, size ranges from 0.5 mm to 1.5 mm, and intended usually for oral administration, manufactured by the agglomerates of fine powders or granules of bulk drugs and excipients using appropriate processing equipment. • Pellets can be prepared by many methods, Agitation, compaction, layering, globulation & other new techniques. Significance • Pellets ensure improved flow properties, and flexibility in formulation development and manufacture.
  9. 9. • Larger surface area of pellets enables better distribution. • Improved appearance of the products. • Varied applications are possible in the pellet form. E.g.: delayed release. • Pellets are less susceptible to dose dumping. • Pellets reduce the variation in gastric emptying rate and transit time. • Pellets disperse freely in G.I.T. and invariably maximize drug absorption and also reduce peak plasma fluctuation.
  10. 10. Methods of pelletization • Agitation/ Balling • Compaction 1. Compression 2. Extrusion/Spheronization • Layering 1. Powder layering 2. Solution/ Suspension layering • Globulation 1. Spray drying 2. Spray congealing • New techniques 1. Cryopelletization 2. Melt Spheronization
  11. 11. Agitation: • In this method finely divided particles are converted to spherical pellets by continuous rolling or tumbling motion using a rotating drum, pan or disc. The liquid may be added prior to or during the agitation stage. Compaction: • Particles or granules are forced together by mechanical force to generate pellets. Reduction in volume is a common feature of this process. 1. Compression: • In this process mixtures of active ingredients and excipients are compacted under pressure to generate pellets of defined shape and size. During compression at high pressure, particles of a packed mass are forced against each other so that elastic and plastic deformation can take place and create strong interparticle contact.
  12. 12. 2. Extrusion & Spheronization: • In this process, the powder is formed into a wet mass, which is forced through restricted area (extrusion) to form strands of extrudate that are broken into short lengths and rounded by placement on a rotating plate with in a cylinder. The resulting spherical granules or pellets are of uniform shape, size and density. Layering: 1. Powder layering: • Powder layering involves the deposition of successive layers of dry powder of drug and/or excipients on preformed nuclei or cores with the help of a binding liquid. 2. Solution/suspension layering: • Solution and suspension layering involve the deposition of successive layers of solution and suspension, respectively, on the starter seeds that are inert materials or crystals or granules.
  13. 13. Principle of solution & suspension layering: Principle of powder Layering:
  14. 14. Globulation: 1. Spray drying: • During spray drying, drug entities in solution or in suspension form are sprayed, with or without excipients, into a hot-air stream to generate dry and highly spherical particles. 2. Spray congealing: • In spray congealing process a drug is allowed to melt, disperse or dissolve in hot melts of gums, waxes, fatty acids, etc. and is sprayed into an air chamber where the temperature is below the melting points of the formulation components, to provide, under appropriate processing conditions, spherical congealed pellets.
  15. 15. New Techniques: 1. Cryopelletization: • In cryopelletization droplets of a liquid formulation are converted into solid spherical particles or pellets by employing liquid nitrogen as the fixing medium. • Drug-loaded pellets are produced by allowing droplets of a solution or suspension to come in contact with liquid nitrogen at -1600C. 2. Melt Spheronization: • In melt spheronization, drug substance and excipients are converted into a molten or semi-molten state and subsequently shaped using appropriate equipment to provide solid spheres or pellets.
  16. 16. References • Chobania A.V, “The Seventh Report of The Joint National Committee on Prevention, Evaluation, Detection & Treatment Of High Blood Pressure: The JNC 7 report. Jama. 289: 2560-72. • Lachman L and Lieberman H A, Kaing J L, ‘The Theory and Practice of Industrial Pharmacy’,3rded, Bombay ,Varghese publishing house :1987. • Indian pharmacopoeia 2007, Vol 3, Monographs on dosage forms, The Indian pharmacopoeia commission, Ghaziabad, 2007, 177-178, 182- 184. • Non Pareil seeds G. M. El-Mahrouk, M. A. Al-Meshal, “Preparation and evaluation of sustained release indomethacin nonpareil seeds”, 1993, Vol. 19, No. 15, Pages 1903-1916. • Chien Y.W, ‘Rate controlled drug delivery system’: controlled release Vs Sustained Release, med.prog.tech, 1989 (15) P.21-46. • Robinson JR, Lee HL (Ed.). Controlled drug delivery, Fundamental & Applications, 2nd edition , Marcel Dekker Inc. New York, 1987: 373. • Vyas S. P. And Khar R K , ‘Controlled drug delivery: Concepts and Advances’,1 ed ,Vallabh Prakashan, New Delhi , 2002.
  17. 17. • G. M. El-Mahrouk, M. A. Al-Meshal, A. A. Al-Angary and G. M. Mahrous, Drug Development & Industrial Pharmacy, 1993, Vol. 19, No. 15 , Pages 1903-1916. • Wagner K.G., Krumme M., Beckert, T.E., Schmidt P.C European Journal of Pharmaceutics and Biopharmaceutics Volume 50, Issue 2, 2000, Pages 285-291. • Haens D, Kovacs A, Vergauwe, P., Nagy F. Journal of Crohn's and Colitis, Volume 4, Issue 2, June 2010, Pages 153-160. • Ameye, D., Keleb, E., Vervaet, C., Remon, J.P., Adams, E., Massart, D.L., 2002. Scaling-up of a lactose wet granulation process in Mi-Pro high shear mixers. Eur. J. pharm. Sci. 17, 247– 251. • Abdul, S., Chandewar, A.V., Jaiswal, S.B., 2010. A flexible technology for modified release drugs: multiple-unit pellet system (MUPS). J. Control. Release 147, 2– ehtauk16.
  18. 18. Thank you

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