Latest Updates on Pharma Colours, Lakes and Dyes by ISPE Standards

Pharma colours are an essential part of the pharmaceutical industry. Be it tablets, capsules, syrups or ointments, colours transform pharmaceutical products from the mundane to the eye-catching. Recent advances in the pharma industry have revolutionised the way our modern medicines are produced and manufactured. Technology has been at the forefront in helping to standardise the process of medicine production, making it attractive using colours while ensuring complete safety and effectiveness of medicines.


What are pharma colours and why are they used?

In addition to Active Pharma Ingredients (API), there are several additives used in pharmaceutical products. These additives include pharma colours that are commonly used in tablets, hard gelatine capsules, soft gelatine capsules, ointments, syrups and compressed tablets.

Pharma colours do not have any therapeutic value. However, they enhance the efficiency of medicine delivery by:

  1. Giving it a unique colour. This makes the medicine easy to identify. Many brands use this property to make their brands distinguishable from other brands.
  2. Increasing the acceptability of the medicine by making it visibly appealing.
  3. Making the medicine flavour correspond with a similar colour. e.g. Cherry flavour syrup is expected to be red.
  4. Identifying counterfeits. The packaging can be mimicked, but duplicate medicines can be identified by the colour (or lack of it).
  5. Increasing shelf life. Opaque pigments can protect the medicine from damage by sunlight and thus improve the shelf life.

Different types of pharma colours or pigments are available. To understand the correct pharma dye or pigment, we need to understand the various types of pharma colours available.


What are the various types of pharma colours used in the industry currently?

  • Water-soluble colours: As the name suggests, these are dyes that dissolve in water completely. Example: Tartrazine and Sunset Yellow.
  • Water-insoluble lakes & pigments: These pigments do not dissolve in water. Example : High purity Iron Oxides is pigment.
  • Organic dyes and lakes: These are synthesised chemically. These pigments display deep colour shades. Example: Lake colour of Azo dyes and Allura red.
  • Inorganic mineral colours: These are mineral-based pigments like Titanium oxide.
  • Lakes: Lakes are aluminium salts of water-soluble dyes. They differ from dyes because they are insoluble and are given their colour by dispersed particles. Example: Red 40 aluminium Lake.
  • Natural plant and animal-based colours: These are mostly obtained from plants and animals and are most suitable for human consumption. Their colour intensity is usually lower when compared to others. Examples: Curcumin, Cochineal, etc.


Is using pharma dyes in medicines safe?

Numerous organisations and international regulating bodies have set parameters and guidelines in using pharma dyes in medicines. Only those dyes that pass these stringent norms can get approval for human consumption. The two most active bodies amongst these are the US FDA and the ISPE.

US FDA: The United States Food and Drug Administration (US FDA) approves pharma dyes, pigments or lakes only if certain parameters are cleared.

The criteria for evaluation take into account:

  1. Effects of consuming the dye, both for long-term and short-term, on the body.
  2. The composition of the dye
  3. Process of manufacturing
  4. Dye stability
  5. Amount expected to be consumed in each dose
  6. The ability of the dye to react to the medicine

ISPE: ISPE stands for International Society for Pharmaceutical Engineering. This is an international non-profit organisation that aims to help its members through advanced scientific research, regulations and technology in the field of pharmacology.

ISPE standardisation ensures that the colourant dyes, pigments and lakes are safe to use. ISPE standardisation sets guidelines on every process involved in pharma manufacturing. The use of colours and dyes in medicines also have to follow the guidelines set by ISPE.


Neelikon Global: A pioneer in pharma colours

Neelikon Global colours have been manufacturing pharma colours, food dyes and pigments for more than 40 years. We have stringent protocols in place that ensure the use of the best quality raw materials and a seamless manufacturing process.

To know more about pharma colours, food pigments and dyes, write to us at

Neelikon Colours Global