In-house vs. ready-to-use film coating preparation. Is there a right choice?

In the pharmaceutical & nutraceutical industry, the focus is always on the quality and efficiency of production processes. A key aspect in the production of pharmaceuticals is film coating technology, which is used to coat tablets with a thin, tasteless and protective layer. Companies are often faced with the decision of whether to produce the film coating solution in-house or use ready-to-use preparations. An informative overview by BIOGRUND published in April 2024.

What is an “in-house film coating preparation”?

In-house film coating preparation refers to the process by which a company manufactures the film coating solutions its own production facilities. This means that the company procures the necessary raw materials for the film coating itself and carries out the formulation and manufacturing process (weighing, mixing) in-house.

These preparations offer companies a degree of control over the manufacturing process and allows them to customize the formulations and properties of the film coating solutions to their own requirements. This can be beneficial for companies that have specific requirements for their film coatings or who wish to fully control their production processes.

However, in-house manufacturing of film coating solutions also presents some challenges, including the need for specialized equipment, skilled personnel and resources for research and development. In addition, in-house manufacturing can be expensive and can be associated with quality risks if the manufacturing processes are not optimized.

Overall, the decision for or against in-house film coating preparation is a strategic consideration that depends on various factors such as the company's specific requirements, available resources and desired control over the manufacturing process.

Steps to be taken for conventional In-house film coating

The disadvantages of in-house manufacturing in short:

• Resource intensive: In-house manufacturing requires significant resources such as time, money and specialized personnel for research, development and production.
• Quality risks: The in-house manufacturing process carries the risk of quality deviations, which can affect product stability and quality.
• Cost factor: In-house manufacturing can be expensive as it requires investment in equipment, training and quality assurance.

What is a “ready-to-use film coating preparation”?

Ready-to-use film coating refers to fully formulated film coating solutions that are produced by external suppliers or manufacturers (e.g. BIOGRUND) and delivered to pharmaceutical and nutraceutical companies as one product. These solutions are already prepared and ready-to-use without the need for further preparation or customization. The premixes are formulated to contain all the necessary ingredients and additives to fulfil the customer's requirements.

The ready-to-use film coating solutions are usually supplied as liquids or powder premixes and can be introduced directly into the production process..

Ready-to-use film coating solutions offer companies various advantages:

• Time and cost efficient: As the solutions are already formulated, companies save time and costs for the internal development and production of film coating solutions.
• Quality control: By using established suppliers, companies can rely on products in a reproducible high quality. They only have to check on product instead of several raw materials.
• Reduced risk: By using ready-to-use solutions, companies can minimize the risk of quality deviations and instabilities that can occur during in-house production.
• Flexibility and scalability: Ready-to-use solutions allow flexible adjustment of production capacity and faster time-to-market for new products.

Overall, ready-to-use film coating solutions offer a practical and efficient way for pharmaceutical companies to optimize their production processes and achieve high-quality film coatings on their solid oral dosage forms.

Reasons for using ready-to-use products

Considerations for film coating

If you decided to use film coating, there a few things you might want to consider:

• Depending on your API you could need different coating formulations. This could be for example due to reactions of API with ingredients of the formulation with alter disintegration.
• If we talk about dissolution profiles of sustained release systems we need to distinguish between highly soluble and hardly soluble APIs and adapt the sustained release coating accordingly. The coordination between the core and the film must be right in order to achieve the desired release profile.
• And last but not less important: We have to adjust the polymers, pigments and the rest of the excipients to meet the official regulatory requirements of the user’s country and consumer driven trends (e.g. clean label; TiO2 free, etc.).

In this context, the choice of reliable suppliers is crucial. Companies such as BIOGRUND offer ready-to-use film coating solutions of the highest quality that meet the requirements of the pharmaceutical industry worldwide.

BIOGRUND's qualification as a second source offers companies the opportunity to take advantage of ready-to-use film coating solutions without relying on a single supplier. This increases the flexibility and resilience of the supply chain and reduces the risk of bottlenecks or quality issues.

Overall, the decision between in-house manufacturing and the use of ready-to-use products is a strategic consideration that companies should carefully weigh up.

Further information on Biogrund

Get your tailored film coating here: https://www.pharmaexcipients.com/tailored-film-coating/

Direct contact to Biogrund by e-mail [email protected].

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