• Core Excipients

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Standard Operating Procedures (SOP) for Coated Tablets

 

Careful adherence to the preparative process is essential for preventing defects in the final coated tablet. Let Colorcon’s experience and technical expertise assist in every step in the process – from core formulation through coating selection and application – to help you achieve the best end result possible.                                                      

Core Substrate Formulation Film Coating Selection

 Coating Application
 

 Core Substrate Formulation

When considering the preparation of a coated tablet, the core or substrate needs to be formulated correctly so it can withstand the mechanical duress and the elevated heat and humidity conditions of the coating process.

The design of a robust substrate has to be considered in terms of:

  • The excipient and active blend is compressible in to tablets of a hardness and friability level that will allow for appropriate drug release.
  • These tablets exhibit hardness and friability properties that will allow them to withstand the stress of the film coating process.
  • The adhesion of the coating to the surface of the core is maximized, especially when a logo, or intagliation, is present.
  • The selected tablet shape is conducive to consistent mixing of the cores in the process and uniform distribution of the coating.
  • The final coated dosage form will meet the ultimate stability objectives.


Success can only be ensured in the film coating process by reconciling the formulation, the tablet design and the production parameters early in the development process. Many of the ingredients chosen in initial tablet formulation development can have a significant impact on aqueous film coating quality. Further, decisions as to the ultimate appearance of the tablet are often left until later stages of development which can force concessions that will negatively impact tablet coating and customer perception of quality.
 
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Film Coating Selection

The selection of the right film coating for the application is critical in order to optimize the adhesion values and tensile properties of the film with the processing conditions required to achieve the best combination of product performance, appearance and process efficiency.

For film coating processes, the latest technology allows for the application of aesthetic and functional films at elevated solids levels when compared to conventional, more mature formulations. The advantages of high solids include but are not limited to the following:

  • Improving productivity and reducing energy and labor costs
  • Speeding the application of the protective coatings to the tablet which ultimately lessens the chance for defects such as edge chipping and erosion
  • The reduction of the amount of water utilized in the procedure, keeping moisture away from tablets containing sensitive actives

With the appropriate early stage consideration a high solids film coating process will produce tablets that are visually identical and are uniformly functional. Please refer to the Standard Operating Procedures for coated tablets for instruction on film coating preparation and use.
 
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Coating Application

Coating at any scale involves the understanding of the interactions between the product being coated, the film coating formulation, the equipment installation and the processing parameters. When a film coating process is transferred and scaled from the laboratory to production equipment many factors must be well thought-out. 

The variable inputs to a film coating process derived from differences in equipment installations include but are not limited to air volume, air temperature, humidity control, and the control system with which the operator interfaces with the machinery. In addition, the coating pan dimensions, the mixing systems or baffle designs and the speed of the coating pan (RPM) add to the list of variables to be measured.

Moreover, the spray rates at which the coating formulation is delivered, the atomization and pattern settings, the nozzle orifice size, the numbers of spray guns, the distance from spray gun to spray gun, and the distance of the spray guns to the tablets will change with scale and can all have a significant impact on the quality of the coated product. 
 
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