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Introduction: Importance of bio-availability and fast disintegration of pharmaceutical tablet is realized and awarness for super-disintegrants in pharmaceutical tablet formulation has also increased. Superdisintegrant viz. Sodium Starch Glycollate was also introduced by Maple Biotech Pvt Ltd. in year 1991, which was appreciated in quality and performance by pharmaceutical industry . Although quest for superior quality superdisintegrant was not over . Superdisintegrant with better stability and superior performance at high tablet hardness level was sought and Maple Biotech's R & D department developed the product Crosslinked Sodium Carboxy Methyl Cellulose which is bearing brand name Cel-Ca-Dissol. Further taking into consideration the requirement for faster dissolution aid for tablets containing ingredients having poor solubility, Calcium Carboxymethylcellulose (Carmellose Calcium) was introduced.
Properties : Carmellose Calcium is white or creamish white in colour and chemically it is Calcium salt of Carboxy Methyl Cellulose with very high degree of purity . Very hard tablets where other superdisintegrants do not perform well Carmellose Calcium performs very much satisfactorily. Quantity to be used in pharmaceutical formulation is very less. Carmellose Calcium helps in dissolution of drugs having poor solubility
Specifications of Carmellose Calcium
|Description||White To Yellowish White Hygroscopic Odorless Powder|
|Identification :||Pass A,B,C,D Of Usp,Bp; Ph. Eur|
|Alkalanity||No Pink Colour Developed On Addition Of Phenolpthalein|
|Sulphated Ash @6000 C||10 To 20 % Bp / Ph Eur|
|Residual Solvent||Not More Than 0.05% Usp|
|Organic Volatile Impurities||Usp|
|Heavy Metals||Less Than 20 Ppm Bp, Ph Eur, Usp|
|Sulphates||1% Bp/ Ph Eur , 0.96% Usp|
|Chlorides:||Less Than 0.5% Bp & Ph Eur/ Less Than 0.36% Usp|
|Silicates||0.6% Bp/ Ph Eur 1.5% Usp|
|Starch||No Blue Colour With Iodine (USP)|
|Total Aerobic Microbial Count||Less Than 1000 Cfu/Gm|
|Total Yeast And Mould Count||Less Than 100 Cfu/Gm|
|Pathogens (E.coli, Pseudomonas Aeruginosa,Staphylococcus Aureus Salmonella)||Absent|