Example: Cimetidine HCl

Direct compression of effervescent tablets

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ExcipientsCustom Synthesis | | Active Ingredients Excipients

ExExActConcepts

Direct compression reduces

the number of process steps

and thereby helps to decrease

process time and cost.

This formulation concept effectively combines

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

Direct compression

Effervescent tablets as dosage

forms must dissolve quickly,

ideally leaving no residue.

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.

Quick dissolution High strength & low friability

Task:Produce an effervescent tablet 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

Effervescent tablets

Chewable tablets

Lozenges

Sublingual tablets

Modifi ed release tablets

SEM Ludipress® LCE

This excipient is specially suitable for

Concept:A BASF excipient

Ludipress® LCE is completely soluble in water and

therefore an ideal excipient for effervescent tablets.

60.9 μm

Example formulationEffervescent tablet with Cimetidine HCI

Composition Parameter setManufacturing instructions

Ingredient Function

2360 mg

Quantity [%]

Cimetidine HCl

API 17.0

Ludipress® LCE

Filler, binder

29.0

PEG 6000 powder

Lubricant 4.0

Aspartame Sweetener 1.5

NaHCO3 Disinte-grant

25.0

Na2CO3 Disinte-grant

2.0

Tartaric acid Buffering-, Complex-ing agent, fl avor enhancer

21.0

Orange fl avor Flavor 0.5

Compression

Tablet press

Korsch PH106

(rotary press

with compres-

sion research

system)

Punch20 mm

diameter

Compression force 28 kN

Pass all ingredients through a sieve

(0.8 mm sieve).

Blend all ingredients for 10 minutes

using a Turbula blender.

Compress mixture into tablet.

Preparation of effervescent tablet

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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

Disintegration time* 3:10 min:s

Crushing strength 189 N

Friability 0.46%

Standard deviation of mass 0.9%

* Apparatus: Ph.Eur. 7.0, TEST A