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CO-PROCESSED

EXCIPIENTS

Presented by- Mr. Bhaskar N. Bangar Mr. Bhaskar N. Bangar

M. Pharm. (Sem. I)

Under the guidance ofUnder the guidance of

Dr. N. H. Aloorkar Dr. N. H. Aloorkar

(H.O.D. Pharmaceutics)

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Contents…………Contents…………

Definition of excipients

Roles of excipients

Need of excipients

Classification of excipients

Excipients used in solid dosage forms

Excipients used in semi-solid dosage forms

Ideal characteristics of excipients

Excipients used in liquid dosage forms

Co-processed excipients

Conclusion

References 3

Co-processing methodology

What are Excipients?What are Excipients?

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Need of ExcipientsNeed of Excipients

Direct clinical use of the active drug substances is rare

due to the number of reasons:

API handling is difficult or impossible.

Accurate drug dosing is difficult or impossible.

API may cause local irritations or injury.

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API can have unpleasant organoleptic properties.

API can be degraded at the site of administration.

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Cont......

Ideal characteristics of excipientsIdeal characteristics of excipients

It should be non toxic.

It should be physically and chemically stable.

It should be commercially available.

It should have pleasant organoleptic properties.

Economic.

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Roles of excipients in different dosage formsRoles of excipients in different dosage forms

Impart consistency and volume

Improve stability

Increase solubility

Enhance bioavailability

Increase patient compliance and acceptability

Impart weight

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ClassificationClassification of excipientsof excipients

Primary excipients : Diluents

Binders

Disintegrants

Lubricants

Antiadhesives

Glidents

Secondary excipients : Flavoring agents

Sweetening agents

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Commonly used excipients in solid dosage Commonly used excipients in solid dosage formsforms

Diluents Binders Disintegrants Lubricants Antiadhesives Glidents

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Commonly used excipients in liquid dosage Commonly used excipients in liquid dosage formsforms

Vehicle Vehicle

Flocculating agents Antimicrobial agents Antimicrobial agents Antioxidants Sweetening agents Flavoring agents

Suspending agents

Preservatives

SUSPENSIONSUSPENSION EMULSIONEMULSION

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Commonly used excipients in semi-solid dosage Commonly used excipients in semi-solid dosage formsforms

Bases

Preservatives

Antioxidants

Chelating agents

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Co-Processed ExcipientsCo-Processed Excipients

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Manufacturing problems in solid Manufacturing problems in solid dosage dosage forms forms

Product weight variation.

Content non uniformity during mixing.

Loss of excipients.

Poor disintegration time of product.

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Particle propertyParticle property Achieving Excipient functionalityAchieving Excipient functionality

Particle size Flow ability, compressibility, disintegration, dissolution rate.

Particle size distribution Segregation potential.

Particle shape Flow ability, content uniformity, compressibility.

Particle porosity Compressibility, solubility.

Particle Properties Achieving Excipient Particle Properties Achieving Excipient FunctionalityFunctionality

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Excipient selection on the basis of material characteristics

Selection of proportion of excipients

Homogenous dispersion or solution

Co-drying

Co-processed excipient

Co-processing methodologyCo-processing methodology

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Manufacturing of co-processed excipietsManufacturing of co-processed excipietse.g. Dicalcium phosphate (diluent) and magnesium stearate (lubricant)

Steps:Steps:

1. Solubalisation

2. Solvent evaporation

3. Drying

4. Sifting

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Properties of co-processed excipientsProperties of co-processed excipients

Absence of chemical change

Improved flow properties

Improved compressibility Reduced lubricant sensitivity

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AdvantagesAdvantages

Provide a single excipient with multiple functionalities.

Better mouth feel and improved palatibility.

Removal of undesirable properties.

Improvement of organoleptic properties.

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Evaluation parameters for co-processed excipientsEvaluation parameters for co-processed excipients

ParticleParticle size distribution-size distribution-

The particle size distribution can be calculated by

statistical method.

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Carr’s index-Carr’s index-

Carr’s index can be calculated by-

Carr’s index= Tapped Density-Bulk Density Tapped Density ˟˟

100

Cont......

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Hausner Ratio-Hausner Ratio-

Hausner Ratio= Tapped Density Bulk Density

Hausner ratio can be calculated by-

Cont......

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REFERENCESREFERENCESAulton’s Pharmaceutics, the design and

manufacture of medicines, third edition by Michael E. Aulton.

Page no: 298-301.B. M. Mithal, A textbook of Pharmaceutical formulation,

vallabh prakashan. Page no. 57-120.Remington- The science & practice of Pharmacy. Page

no. 896-910.Ansel’s Pharmaceutical dosage form. Page no.198-

199, 240-242.www.google.comwww.wikipedia.com/coprocessed excipients

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