The art of reformulation: tablet formulations redefined

In the world of pharmaceuticals and dietary supplements, continuous development and improvement is at the forefront - especially in solid oral dosage forms (SOD). One way to refine is to reformulate existing tablet formulations. This process can help optimize the efficacy, tolerability and stability of SODs, open up new areas of application and improve patient care.

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Why is reformulation of oral dosage forms important?

For example, tablet reformulation is a sensitive step in pharmaceutical & nutraceutical development that is important for several reasons:

1. Improved efficacy: by optimizing the formulation, the active ingredients of a dosage form can be better released and absorbed. This can result in the drug or dietary supplement being more effective and working faster.
2. Better tolerability: some consumers may be allergic to or suffer side effects from certain ingredients in a formulation. Reformulation can minimize adverse reactions.
3. Broadening the scope of use: redesigning an existing formulation can lead to a product being used for new applications - e.g. reformulating a capsule into a tablet.
4. Patent expiration and generics: when the patent for a drug expires, other manufacturers may produce generic versions. Reformulation can help to offer drugs in an improved form and thus remain competitive.

Steps of tablet reformulation

Tablet reformulation requires careful planning and execution. Here are some of the most important steps:

1. Active ingredient analysis: identification and characterization of the active ingredient is the first step. This includes, e.g. checking stability, solubility and bioavailability.
2. Excipient selection: the choice of the right excipients, such as binders, fillers, flow agents and lubricants, is crucial for the formulation.
3. Formulation development: the development of the new tablet formulation requires laboratory tests and trial runs. Here, various combinations of active ingredients and excipients are tested to find the optimum composition.
4. Testing and analysis: the newly developed formulation is analyzed for stability, release rates and other pharmaceutical parameters.
5. In vivo studies: in some cases, clinical studies are necessary to verify the efficacy and tolerability of the reformulated tablet.

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Challenges of reformulation

Reformulation is a promising approach, but it also presents some challenges:

1. Patents and regulations: Compliance with patents and regulatory requirements can be complex and delay access to market release. For example, one or two excipients in an existing tablet may also no longer be allowed to be used (e.g. titanium dioxide in food within the EU) and must be replaced with alternatives.
2. Cost: The development and implementation of a new pharmaceutical formulation can be expensive, especially if clinical trials are required.
3. Stability and tolerability: reformulation may affect the stability of the drug or cause undesirable side effects.

Although this process is fraught with challenges, it offers great opportunities for healthcare and consumer well-being. BIOGRUND is therefore intensively addressing the issue of reformulation and offers the reformulation service to its customers - especially for tablet core and film-coated formulations.

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What BIOGRUND offers:

BIOGRUND is a company specializing in the development and manufacture of excipient premixes for the pharmaceutical and dietary supplement industries. Our customized products facilitate the production process of solid oral dosage forms. BIOGRUND accompanies its customers from development to production:

1. Excipients for formulation optimization: BIOGRUND builds on a wide range of excipients that can be used in tablet formulation. These include binders, fillers, lubricants, flow agents, disintegrants, film formers, pigments and others. These can help control the release of the active ingredient, increase stability and improve the mechanical properties of the tablets, among other things.
2. Adaptation to specific requirements: Depending on the requirements, BIOGRUND develops new formulations. We assist in finding the right combination of excipients to meet the needs of the project.
3. Consulting and support: BIOGRUND has an experienced team of pharmacists and chemists who assist in the development and optimization of tablet formulations. We can provide recommendations for suitable excipients and assist in solving formulation challenges and produce needed excipient mixtures ourselves.
4. Quality control and analysis: BIOGRUND can perform quite a few analyses and tests to ensure that the reformulated dosage form meets the desired quality and stability standards.
5. Regulatory requirements: Meeting regulatory requirements is critical to bringing drugs to market. BIOGRUND can provide supportive services in this regard.
6. Sustainability and compliance: BIOGRUND attaches great importance to sustainability and compliance with environmental and quality standards. Thus, we regularly get certified according to ISO, Organic and Excipact (GMP) standards.

Learn more about BIOGRUND. Click here.