Example: Cetylpyridinium chloride

Direct compression of lozenges

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ExcipientsCustom Synthesis | | Active Ingredients Excipients

ExExActConcepts

This formulation concept effectively combines

Convenient manufacturing based on direct compression è one-step tableting and trouble-free processing

Direct compression reduces

the number of process steps

and thereby helps to decrease

process time and cost.

Direct compression

Hardness throughout the

handling of tablets is often of

great importance. This applies

to handling through a patient

as well as handling in preced-

ing work stages, e.g. coating.

High strength & low friability

Lozenges are mainly applied

in the local treatment of soar

throats. The drug remains in

the oral cavity for an extended

period of time and therefore

has a local effect there.

Benefi ts through lozenges

Task:Produce a lozenge by direct compression

Ludipress® LCEan excipient for direct compression,

shows excellent compression properties:

• High compressibility

• Excellent fl owability

• Low lubricant sensitivity

• Outstanding blending behavior with actives

Lozenges

Chewable tablets

Effervescent tablets

Sublingual tablets

Modifi ed release tablets

SEM Ludipress® LCE

This excipient is specially suitable for

Concept:A BASF excipient

60.9 μm

Example formulationLozenge with Cetylpyridinium chlorid

Composition Parameter setManufacturing instructions

Pass all ingredients through a sieve

(0.8 mm sieve).

Blend all ingredients for 10 minutes

using a Turbula blender.

Compress mixture into tablet.

Ingredient Function

420 mg

Quantity [%]

Cetyl-pyridi-nium chloride

API 2.5

Ludipress® LCE

Filler, binder

370.0

Kollidon® 90 F

Binder 20.0

PEG 6000 powder

Lubricant 20.0

Aspartame Sweetener 1.5

Menthol Flavor 6.0

Preparation of lozenge Compression

Tablet press

Korsch PH106

(rotary press

with compres-

sion research

system)

Punch10 mm

diameter

Compression force 30 kN

* Tablet hardness dependent

on compression force

03_120811e-0

0

BASF SEPharma Ingredients & ServicesChemiestraße 22

68623 Lampertheim

Germany

Phone: +49 621 60 - 0

www.pharma-ingredients.basf.com

pharma-ingredients@basf.com

Disclaimer

The data contained in this publication are based on our current knowledge and experience. In view of the many factors that may affect processing and application of our

product, these data do not relieve processors from carrying out their own investigations and tests; neither do these data imply any guarantee of certain properties, nor the

suitability of the product for a specifi c purpose. Any descriptions, drawings, photographs, data, proportions, weights etc. given herein may change without prior informa-

tion and do not constitute the agreed contractual quality of the product. It is the responsibility of the recipient of our products to ensure that any proprietary rights and

existing laws and legislation are observed. (01 / 2012) ® = registered trademark of BASF SE

Analytical results

Crushing strength 224 N

Disintegration time* 28:02 min:s

Standard deviation of mass 1.2%

* Disintegration time can be adjusted by chan-

ging compression force and incorporation of

a high molecular weight polymer binder

Apparatus: Ph.Eur. 7.0, TEST A