Coating is required on solid dosage form either to protect the drug from atmospheric condition, to give an aesthetic look or for masking taste and odour. Coating also enhances the stability of drug and perform target delivery.
Coating started with sugar deposition on tablet to mask its bitter taste. Although it was introduced way back in 1954 by Abbott Laboratories, USA to commercialize their first batch of non enteric film coating product, it took time to get itself introduced and adapted by the pharmaceutical industry all over the globe. Initially sugar coating was popular as the only technology available to coat a tablet in order to mask its taste or odour.
However this four to five decade old process had various complications and disadvantages in terms of product & process. Sugar coating takes 8 to 12 hrs to coat one single batch which means tremendous consumption of electric power as well as excessive man hours. Sugar is hygroscopic in nature. Thus it needs 100 per cent water proof packing. Also the size of original tablet increases by almost 80 to 100 per cent after coating. This requires larger volume of packaging material which adds in packaging & transportation cost. Also trained & skilled operator is required for sugar coating.
To overcome all the above disadvantages of sugar coating, a new coating technology known as ‘Film Coating’ was developed. Film Coating can be described as “Thin deposition of polymeric material (approx 30-50 micron) on the surface of a pharmaceutical / ayurvedic solid dosage form”
Film Coating which is known as Latest Generation Coating is an efficient process as compared to sugar coating in terms of quality & duration (hardly takes 2 to 3 hrs) for batch completion. If one selects Readymix coating material for Film Coating then no reprocessing of batch is required. There is no necessity to have a skilled operator.
Initially Readymix had been a monopolistic product & thus used to be very expensive. Indian pharma companies needed to import this product.
Apart from this , Readymix was earlier available only in huge package sizes, making it compulsory for the buyer to procure extra material than what was required for coating. This resulted in accumulating unwanted inventory.
WINCOAT became the pioneer by introducing the Readymix manufacturing technology in India during 90’s. Wincoat made their Readymix material available in smaller package size starting from 1 kg, 2 kg, 5 kg onwards. Easy & flexible availability in small package sizes subsequently resulted in reduction in price to a huge extent.
Advantages of Film Coating :
Advantages of Film Coating starts right from the Product development. This department decides the tablet (product), its colour shade and nature of coating. WINCOAT assists them in selection of colorants, considering legislative requirements of respective country where they would like to sell. WINCOAT also provides guidance on stability and interaction of colorants. WINCOAT has a software which enables its
customers to create their own customised shade.
Next advantage is for the purchase department. Readymix enables single purchase thereby reducing the multiple purchases required for Inhouse preparation. This leads to saving on generation of 5 to 6 purchase orders and their vigorous follow up.
Also if single ingredient doesn’t reach on time, the whole process of coating gets delayed. In case of Readymix, inventory is almost negligible as one can order a single WINCOAT ready mix pack as per requirement, instead of purchasing huge quantities of individual raw materials which prevents blocking of money and also helps in saving storage space
Testing for quality control department is limited to single product in case of readymix as against 5 to 6 different ingredients in the case of Inhouse coating preparation. Single testing helps in saving time of chemist and expensive chemicals and reagents. For the stores department, it is single dispensing thus making it easier to handle & also saving time.
Production operations also become very simple and quick. One step operation of suspension making saves precious processing time. Here it is pertinent to mention that WINCOAT assures consistent colour shade. For this commitment WINCOAT has developed an inhouse colour matching software to ensure accurate colour shade batches after batches. With every consignment, WINCOAT provides computer generated graphical colour matching reports along with regular COA & qualitative formula.
WINCOAT provides aqua-smooth* coating assuring smooth, uniform coating without Logo-Bridging. For eliminating Logo-Bridging, WINCOAT adjusts surface tension of its Readymix.
Selection of Readymix
If the Readymix fails to perform at final stage of coating, customer has to reprocess the whole batch or discard the batch. Thus selection of appropriate Readymix is of prime importance to ease the process of film coating and to avoid unpleasant reprocessing due to poor performance of coating material. WINCOAT provides the best quality product with efficient technical service backup.
Making Readymix is not only mixing 4-5 ingredients together, but one has to consider the final performance of Readymix. While making Readymix, the manufacturer must make use of the knowledge of colour chemistry, physical chemistry and organic chemistry.
WINCOAT is having international certifications like WHO GMP, US-DMF, Halal, Kosher & ISO 9001-2008.
From its inception the company has promoted Aqueous Film Coating i.e. Water base Coating as it is cost saving, non- hazardous and also helps to maintain clean environment.
-The author is Managing Director of Wincoat