A Seminar onA Seminar onCOPROCESSED EXCIPIENTCOPROCESSED EXCIPIENT

MVP’S COLLEGE OF PHARMACY,NASHIK MVP’S COLLEGE OF PHARMACY,NASHIK

Presented by Guided byMr. NITIN P.KANWALE Dr. D.V. DERLE Department of Pharmaceutics

Content Definition Co-processing Need of Co-processed Excipients Methods of Preparation Advantages Evaluation Parameter Examples Multifunctional Excipients Conclusion References

2

Definition

Excipients-

Excipients are the ingredients which are intentionally added to the pharmaceutical products to improve their performance but don’t have any therapeutic effect.

Co-processed Excipients-

Combination of two or more compendial or non compendial excipients to physically modify their properties.

3

Co-processing

4

Co-processing is a process in which two or more excipients interacting at the sub particle level, the objective of which is to provide a synergy of functionality improvements as well as masking the undesirable properties of individual excipients.

The main aim of co‐processing is to obtain a product with added value related to the ratio of its functionality / price.

Need for developing Co-processed Excipients

The growing popularity of the direct‐compression

process & demand for an ideal filler–binder that can

substitute two or more excipients.

The ability to modulate the solubility, permeability, or

stability.

To address the issues of flowability, compressibility,

and disintegration potential.

5

Method Advantages & Limitations

Examples

Spray drying Spherical shape and uniform size, good flowability, poor reworkability

SD lactose, Emedex, Fast Flo Lactose, Avicel, Karion Instant,TRI-CAFOSS, Advantose

Granulation / Agglomeration

Transformation poorly flowable powders into flowable and directly compressible.

Granulated lactitol, Tablettose

Dehydration Increased binding properties

Anhydrous α- Lactose

6

Method

Advantages

Improved Flow Properties

Improved compressibility

Better dilution potential

Fill weight variation

Reduced lubricant sensitivity

7

Evaluation Parameter

Carr’s Index

Hausner’s Ratio

Angle of repose

Particle Size Distribution

8

Example Name Supplier Ingredients %

Ludipress BASF Lactose 96.5

PVP 3.5

Starlac 100 Meggle α Lactose monohydrate

85

Maize Starch 15

Advantose FS SPI Fructose 95

Starch 5

Xylitab 200 Danisco Xylitol 98

SCMC 2

9

Modified MCC-Name Supplier Ingredients %

Avicel®

HFEFMC MCC 90

Mannitol 10

ProSolv® JRS MCC 98

Colloidal Silicon Dioxide

2

Avicel® CE15 FMC MCC 85

Guar gum 15

Avicel® DG FMC MCC 75

DiCalcium Phosphate 25

10

Multifunctional Excipients

Multifunctional Excipients are the class of excipients

that includes pre-processed & co-processed

excipients that provide multiple functionalities to

the formulation.

These functionality includes flowability,

compressibility, particle size distribution, shape,

porosity etc.

11

Steps in Co-processing of Multifunctional Excipients-

12

Examples of Multifunctional Excipients-

Name Ingredients Functions

StarCap® 1500 Corn starch, pregelatinised starch

Disintegrant, Flowability, Dissolution properties

Fujicalin® Dibasic Calcium Phosphate

Flowability, Compressibility, Disintegration,

MC200G Mannitol, Calcium silicate

Chewable properties, flowability, Compressibility

13

Name Ingredients Functions

Pharmatose®

DCL 40Β-Lactose, Lactitol

Good flowability, High dilution potential, Low water uptake

PanExcea®

MCC333GHPMC, MCC, Crosspovidone

Flowability, Compressibility, Disintegration, Binder, Filler, High API loading

Ludiflash® Mannitol, Kollidon CL-SF, kollicoat SR 30D

Creamier mouthfeel, Flowability, Hardness with ,low friability

14

Conclusion

The concepts of material science and advanced

technologies have shown an alternate path to obtain a new

class of excipients known as Co-processed and

Multifunctional excipients.

Their manufacturing is very simple with marginal cost of

production.

They serve as multipurpose excipients, providing a better

option of Excipient selection to the growing industries.

15

References1. Chougule Ajay Subhash, Dikpati Amarita, Trimbake Tushar,

Formulation development technique of co-processed excipient, Journal Of Advanced Pharmaceutical Sciences, 2012,Vol.2, 231-249.

2. Ushari.S, Prasanthi C.H, Reassessment of novel co-processed multi-

functional excipient, International Research journal Of

Pharmaceutical and Applied Sciences,2013 ,122-128.

3. Marwaha Minakshi ,Sandhu Dipak, Marwaha Rakesh Kumar, Co-

processing of excipient: A review on excipient development for

improved tableting performance, International Journal Of Applied

Pharmaceutics, vol 2,41-47.16

17

4. Aulton’s Michel E, The design and manufacture of medicine,churchill livingstone elsevier, third edition, 2007, 355-356

18