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PHARMACEUTICAL SOLUTIONS

PHARMACEUTICAL COLOURS

All is not perfect when formulating with natural colours:

Stability – in some formulations, use of natural colours is limited due to UV, formulation compatibility (heat, fruit acids, aeration of bulk, preservative system, high sheer, etc), pH, etc. A good example is enocianin, which has a red to violet-red colour at a pH below 3.5; at a higher pH, the colour shifts to a more bluish-violet. Another example is annatto extract, which is not stable with some of the calcium salts and is also pH-sensitive.

Percentage inclusion – in most instances, more natural colour material must be is used compared to synthetic colours to get to the same level of colour intensity, as the active dye content of primary synthetic colours is much higher.

Cost – most natural colours are slightly more expensive per unit, depending on the colour in question, compared to synthetic colours.

Minimum pack size – it is important to check the pack size of the material as one has to be able to consume it all before the expiry date.

Storage – most natural colours require specific controlled storage conditions that also, in some instances, indirectly add to the cost.

Colour pallet limitations – natural colours are limited when looking at the colour pallet available from synthetic colours. Blending some natural colours to achieve specific shades might also prove to be challenging in various ways.

The extraction process used – it is important to know the extraction processes for the natural colours, which may result in some colours not being kosher.

Purity – some natural colours are modified using complex formations, ion exchange and saponification, and it is important that they meet purity criteria and satisfy legislation both for purity and use.

TABLET COATINGS

Film coating has become the preferred method of coating tablets versus sugar coating. The reason for this is that film coating results in shorter processing times as well as minimal mass gain, improved aesthetics, improved handling and improved drug release. Processing variables are more complex compared to sugar coating, which is done in a conventional coating pan. Some critical parameters that influence film coating are physical properties of the tablets cores such as shape, surface area (size) and friability. Process variables include tablet bed temperature, inlet temperature, outlet temperature, air volume, batch size, type of equipment used, spray rate, spray pattern and pan speed. All the above-mentioned have to be specific to each film-coating system as well as the medium being coated. Batch validation is therefore a critical process for each film-coating system.

PHARMASPEC ™ FC is a ready-to-use system and is extensively utilised with exceptional results. The reason for PHARMASPEC ™ FC being used and accepted so widely is its ability to introduce high levels of solids, thus reducing mixing and spraying time. Instant release of film coat also ensures superior drug absorption, smooth edges and surfaces with no logo bridging. A variety of colours both from natural and synthetic origin are available. Existing colours can also be shade and colour matched very successfully. PHARMASPEC ™ FC is an alternative that yields superior results, taking film coating to the next level of effectiveness both from a cost and a quality point of view.

Spectratec Inc. can also supply most market equivalents of tablet coatings based on PVA, HPMC and Metacrylic acid co-polymers. 

16 points benefits and advantages of PHARMASPEC™ as a complete film-coating system:

  • Fast and easy to use – increased productivity
  • Ultra-low viscosity polymers with increased pigment loading
  • Superior moisture barrier of hygroscopic and moisture-sensitive formulations
  • Superior taste barrier (flavours/ sweeteners can be incorporated to mask pungent materials)
  • Uniform coating with no logo-bridging or filling
  • Improved reconstitution time – reduces delays
  • No sticking together of tablets
  • Lower temperature required (35°C-40°C) ensures stability of API.
  • Very easy to clean – almost no residue
  • Versatile – can be used in aqueous or solvent systems
  • Can successfully coat in most commercially available coating machines
  • Shade and colour-matching available to Pantone references
  • Technical support and experience available
  • Kosher and halaal certified colours are used, TSE/BSE, Non-GMO, Melanmine free, OVI declaration.
  • Unique colour identification
  • Improvement of patient compliane

16 points benefits and advantages of PHARMASPEC™ as a complete film-coating system:

16 points benefits and advantages of PHARMASPEC™ as a complete film-coating system:

  • Fast and easy to use – increased productivity
  • Ultra-low viscosity polymers with increased pigment loading
  • Superior moisture barrier of hygroscopic and moisture-sensitive formulations
  • Superior taste barrier (flavours/ sweeteners can be incorporated to mask pungent materials)
  • Uniform coating with no logo-bridging or filling
  • Improved reconstitution time – reduces delays
  • No sticking together of tablets
  • Lower temperature required (35°C-40°C) ensures stability of API.
  • Very easy to clean – almost no residue
  • Versatile – can be used in aqueous or solvent systems
  • Can successfully coat in most commercially available coating machines
  • Shade and colour-matching available to Pantone references
  • Technical support and experience available
  • Kosher and halaal certified colours are used, TSE/BSE, Non-GMO, Melanmine free, OVI declaration.
  • Unique colour identification
  • Improvement of patient compliane

PHARMASPEC™ is a complete system that has been developed based on the latest German technology. This system is a ready-mix fine powder blend of the highest quality film-forming polymers, plasticisers and pigments. PHARMASPEC™ is manufactured with raw materials that comply with the latest USP, BP, EU Pharmacopeia and FDA standards. This system provides protection of the active against light, oxygen, moisture and other functional components (sub-coating).

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