(mups) novel pellets for oral dosage forms

22
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. 7 th Sem. University Roll No. - 20101911022 & Prosenjit Chakraborty B. Pharm. 7 th Sem. University Roll No. - 20101911026 1

Upload: nilanjan-bhattacharya

Post on 02-Jul-2015

530 views

Category:

Health & Medicine


0 download

DESCRIPTION

novel pellets for oral dosage forms

TRANSCRIPT

Page 1: (Mups)  novel pellets for oral dosage forms

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

Page 2: (Mups)  novel pellets for oral dosage forms

Pelletization can be defined as an agglomeration(size-enlargement) process that converts fine powdersor 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 unitsformed by a size-enlargement process that includes aspheronization step where extrudates or agglomeratesare rounded as they tumble on a rotating frictionalbase plate, being named “spheroids”. 2

Page 3: (Mups)  novel pellets for oral dosage forms

Spherical shape and smoothsurface is considered asdesired characteristics foruniform film coating.

The particle size of pelletsshould be in range of 0.5 to2.0 mm.

The quantity of the activeingredient in pellets shouldbe maximum in order tomaintain size of pellet. 3

Page 4: (Mups)  novel pellets for oral dosage forms

They can be divided in to desired dosage strengthwithout process or formulation changes.

They can be blended to deliver incompatible bioactiveagents.

They can be used to provide different release profile atthe same or different sites in the gastrointestinal tract.

When pellets containing the active ingredient are inthe form of suspension, capsules, or disintegratingtablets, they offer significant therapeutic advantagesover single unit dosage forms. 4

Page 5: (Mups)  novel pellets for oral dosage forms

5

Page 6: (Mups)  novel pellets for oral dosage forms

Agitation can be further classified underBalling, which is –

A technique is not popular in thepharmaceutical industry as a Pelletizationprocess.

This is because due to the constraints ofparticle size distribution and contentuniformity.

Work in this area is expected to continue.

6

Page 7: (Mups)  novel pellets for oral dosage forms

Compaction is a form of pressure agglomeration, inwhich drug particles or granules are forcedtogether with or without formulation aids by amechanical force to generate pellets of welldefined shapes and sizes.

The Pelletization process can be subdivided intocompression and extrusion.

7

Page 8: (Mups)  novel pellets for oral dosage forms

In this process, drug is layered onto seed materials(generally, a coarse material) in powder, solution orsuspension form and leads to heterogeneous pellets,which consist of an inner core region and an outershell 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

Page 9: (Mups)  novel pellets for oral dosage forms

9

Page 10: (Mups)  novel pellets for oral dosage forms

10

Page 11: (Mups)  novel pellets for oral dosage forms

11

Page 12: (Mups)  novel pellets for oral dosage forms

It is a process where hot melts, solutions, orsuspensions are atomized to generatespherical particles or pellets.

In globulation, atomization produces solidparticles directly from the liquid phase throughevaporation or cooling and subsequentsolidification of hot melts, solution andsuspension.

12

Page 13: (Mups)  novel pellets for oral dosage forms

It is an approach that has come into existencewhich combines the features of both controlledrelease tablets and modified release capsulesin one dosage form, such a system is known asMUPS tablets or Multiple-Unit Pellet System.

13

Page 14: (Mups)  novel pellets for oral dosage forms

When taken orally, multiple unit dosage forms-

Disperse freely in the gastro intestinal tract.

Offer reduced variation in gastric emptying rateand transit time which is less dependent on thestate of nutrition.

Reduces localized concentration of irritativedrugs.

Improves safety and efficacy of a drug. 14

Page 15: (Mups)  novel pellets for oral dosage forms

Should maintain all the tablet properties.

Pellets should not show any interaction likedeveloping electrostatic charges during compression.

The drug release should not be affected by the

compaction process.

Like tablets, MUPS should have ease to withstandphysical parameters, stability, packing storage andtransportation.

The dosage form must disintegrate rapidly intoindividual pellets in gastrointestinal fluids.

15

Page 16: (Mups)  novel pellets for oral dosage forms

MUPS formulations are broadly classified into two types :

A. MUPS with matrix pellets

B. MUPS with pellets coated

16

Page 17: (Mups)  novel pellets for oral dosage forms

Pellets which inherentlycontain excipients that slowsdown the drug release bybeing contained within thematrix of pellet structurecommonly referred as MUPSwith matrix pellets .

For example matrix pellets ofswellable polymers or waxes,retain their controlledrelease characteristics to alarger extent.

Fusion of matrix pellets as aresult of compaction can beavoided by application of filmcoating or by excessiveblending with a hydrophobicagent.

17

Page 18: (Mups)  novel pellets for oral dosage forms

There are several types of coating, they are followed by :

18

Page 19: (Mups)  novel pellets for oral dosage forms

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

Page 20: (Mups)  novel pellets for oral dosage forms

Thus we see that the present scenario of MUPS finda greater advantage due to its flexible design in variablerelease properties, stability, patient compliance andeconomic compared to other dosage forms.

For the pharmaceutical industry, not only theinnovation of new products and techniques, creation ofline extension, expansion of patent protection, achievingglobalized product and thereby overcome competition arealso key strategies with respect to profit perspective.

MUPS meet all these with medical, health care, andbusiness benefits.

20

Page 21: (Mups)  novel pellets for oral dosage forms

Reddy S ,Das P, Das H, Das,Ghosh A, MUPS (Multiple UnitPellet System) Tablets – A BriefReview, JOURNAL OFPHARMACEUTICAL ANDBIOMEDICAL SCIENCES, 2011,Vol 12 (02)

N.Jawahar, Patel H.A, Multi UnitParticulates Systems (MUPS): ANovel Pellets for Oral DosageForms Journal Of PharmaceuticalScience 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, PELLETIZATIONTECHNIQUES USED INPHARMACEUTICAL FIELDS.Practica Farmaceutică, 2011, Vol.4

VR Sirisha K, K Vijaya sri, K

Suresh, G Kamalakar Reddy,MULTIPLE UNIT PELLETSYSTEMS: A REVIEW , Int J

Pharm 2012; 2(2)21

Page 22: (Mups)  novel pellets for oral dosage forms

22