CARMECEL - P (CC) a superior tablet disintegrator is a result of the sustained R&D efforts of   the Ashok Brothers Products Limited the pioneer in developing Cellulose products in India.

 * Used in Tablet Dissolution / Disintegration.
 * Used in Both Wet granulation and Direct Compression.
 * Distinct Advantages over other Tablet Disintegrators.
 * Effective even at low use Levels.
 * Superior long term Dissolution Stability.
 * Insensitive to Tablet Hardness.

INTRODUCTION

Pharmaceutical formulators understand that for quick remedies effective absorption of drug is necessary which in effect means that the tablet consumed should be Disintegrated so as to expose the drug to the gastric fluids which results in the dissolution of the drug and improvement in subsequent bioavailability.  Formulators using available disintegrators face problems like long term functional stability, reduced effectiveness at high tablet hardness levels and high use levels needed to achieve desired performance.

CARMECEL -P (CC) a tablet disintegrator developed by Ashok Brothers over-comes most of these problems, the distinctive disintegrative functionality being a result of its unique properties and chemical structure.

USES

CARMECEL -P (CC) is used as a tablet disintegrator i.e., for breaking down the tablets so that the drug is exposed to the gastric fluids.  It can be used both in wet granulation and direct compression.  Carmecel -P (CC) due to its unique properties and chemistry has many advantages over other commonly used disintegrates.

PROPERTIES

The Chemistry of CARMELLOSE gives it several unique and excellent properties, which explains its consistent disintegrative functionality.

* High capillary action - good water intake.
* Rapid swelling properties - hydrophilic nature
* Relatively long fibre length provides efficient fluid channeling.

WORKING

As earlier mentioned rapid disintegration of tablets can aid in the dissolution of  the drug and improve its subsequent bioavail ability.  This can be accomplished through various mechanisms or a combination of mechanism, water wicking & disintegrant swelling represent two commonly used means. CARMECEL - P (CC) by virtue of its fibrous nature has amazing water wicking capability and its cross - linked   chemical   structure creates an insoluble hydrophilic, highly absorbant material which results   in good swelling   properties.   This dual functionality translates into superior disintegrating characteristics at very low use levels.  Studies       to evaluate the properties of various tablet disintegrators have shown the superiority of CARMECEL - P(CC)  over  other  tablet  disintegrators  in  terms of  the rate of water uptake as well as the change in tablet thickness. CARMECEL -P(CC) is used in both wet granulation and direct compression.

USAGE OF CARMECEL -P (CC) IN WET GRANULATION

CARMECEL -P (CC) is recommended in both wet and dry phases of wet granulation. This way the wicking and swelling properties of CARMECEL -P (CC) are best utilized to improve drug dissolution.  In the wet mixing process an intimate mixture of CARMECEL -P (CC) drug, binder and   filler   with the granular matrix allows CARMECEL -P (CC) to break down the granules by utilising its swelling characteristics to rupture the tablet and expose greater surface area of the drug to the gastric fluids. Similarly addition of CARMECEL -P(CC)  during  the dry blending step places  CARMECEL -P(CC)  into  the  extra granular  structure  where  its  fibrous nature and where its  fibrous nature  and  wicking  ability  carry  fluid   throughout  the tablet.  The intragranular and   extra granular distribution of CARMECEL -P (CC) also helps to achieve better distribution of the disintegrant and optimise its functionality.

USAGE   OF CARMECEL - P (CC) IN DIRECT COMPRESSION

CARMECEL -P (CC) should be added to the other formulation components and dry blended to
 a homogenous mixture,  prior to the addition  of  lubricants.  The uniform distribution of CARMECEL-P (CC) into the tablet mixture will enable it to wick water and swell thereby breaking the tablet apart and exposing more surface area of the drug to the gastric fluids.

ADVANTAGES OF CARMECEL - P (CC) EFFECTIVE AT LOW USE LEVELS.

CARMECEL -P(CC) can typically be used at very low levels to achieve desired tablet disintegration  results. Comparative studies using other tablet disintegrators have shown that CARMECEL -P (CC) takes less than half the time as compared to other disintegrators for  initial disintegration.    

CARMECEL - P (CC) takes less than half the time as compared to other disintegrators for initial disintegration.  CARMECEL-P (CC) also showed comparatively aritively faster disintegration time for various periods of storage. This superiority was  confirmed at various use levels.  At 0.5% use level and at 6 Kg hardness tablets showed initial disintegration time of less than 5 minutes and even after 6 months of storage gives disintegration times of less than 20 minutes. This that the formulator has to use very less amounts of tablet to disintegrator whereas earlier he had to use large amounts of disintegrator to achieve the same level of disintegration

INSENSITIVE TO TABLET HARDNESS

In most of the current crop of tablet disintegration as tablet hardness increases the disintegration time also increases whereas studies show that CARMECEL -P(CC) shows very little change in disintegration time relative to tablet hardness. This meant that with other tablet disintegrates the formulators had to be careful as increased tablet hardness would destroy the disintegrative capability of the disintegrants where as with CARMECEL -P (CC) there would   be minimal or negligible effect of increasing tablet hardness

SUPERIOR LONG TERM DISSOLUTION STABILITY

The disintegrative capability of available disintegrants wears down in course of time that is as the storage period of shelf life of the tablet increases.  It becomes more to break the tablet, thereby reducing its effectiveness.  CARMECEL -P(CC) on the other hand  exhibit  superior  long-term  dissolution stability. This meant that a tablet well granulated with CARMECEL -P (CC) shows virtually no change in disintegration time whereas other disintegrants show significant drop in dissolution rate over time.

PACKING AND STORAGE

CARMECEL - P (CC) is supplied in 25 kilos net weight in Drums/HDPE Polylined sacks with extra liner inside. It should be stored in the dry place under which conditions, it can be kept indefinitely.

N.B. While information contained in this bulletin is accurate to the best of our knowledge, it implies no Guarantee and freedom from patent restrictions cannot be assumed

TOXICOLOGICAL TESTS CARRIED OUT SHOWS NO TOXICOLOGICAL EFFECTS UNDER STUDIED CONDITIONS.