IR/ER/MR Tablet Development

What is IR/ER/MR Tablet?

• IR tablet, also known as immediate-release tablet, refers to a type of tablet that releases the active ingredient of the drug immediately after oral administration.
• ER tablet, also known as extended-release tablet, refers to a type of tablet that can slowly and sustainably release the active ingredient of the drug after oral administration.
• MR tablet, also known as modified release tablet, refers to a type of tablet that changes the release time and/or rate of the drug in the formulation.

In conventional tablet designs, there is no way to modify the release rate of the drug, which results in faster absorption, lower bioavailability, and concomitant poorer efficacy. Currently, ER/MR tablets have been a more effective treatment alternative to IR tablets (conventional tablets). In order to achieve the desired therapeutic goals or better patient compliance, more and more pharmaceutical companies are focusing their research and development on the development of MR /IR tablets, which control the gastrointestinal tract absorption by controlling the release of API to achieve better therapeutic effects and patient experience.

Explore Our IR/ER/MR Tablet Development Services

Thanks to our innovative sustained-release oral solid dosage platform, CD Formulation excels at developing various oral IR/ER/MR tablets to address solubility and release challenges. Our team of experienced formulators and scientists can create customized formulations that optimize drug solubility and release profiles, leading to improved bioavailability and therapeutic efficacy.

Importantly, our team of highly qualified experts considers the target product profile (PPT) of your drug to efficiently develop scalable formulations. The types of IR/ER/MR tablets we can develop include but are not limited to:

• Conventional tablets
• Mini tablets
• Enteric-coated tablets
• Orally disintegrating tablets (ODT)
• Targeted tablets
• Double-layer matrix tablets
• Multilayer tablets
• Sustained release tablets

Our IR/ER/MR Tablet Development Services Include:

• Preformulation studies to evaluate API properties and solubility.
• Formulation optimization to enhance drug dissolution and release kinetics.
• Excipient selection to improve drug stability and bioavailability.
• In vitro and in vivo testing to assess formulation performance.
• Scale-up and manufacturing support to facilitate commercialization.

General Workflow of IR/ER/MR Tablet Development Services

• Formulation Design

Our scientists will develop the best strategic plan based on the physical and chemical properties of your API, including solubility and stability.

• APIs with poor stability are usually designed as film-coated tablets to ensure that they will not be affected during storage and use.
• APIs with poor solubility are usually designed into sustained-release tablets or controlled-release tablets to extend the release time of the drug in the body, improve the bioavailability of the drug, and reduce the side effects of drugs. Of course, we will customize the design according to your specific needs.

• Feasibility Assessment

In the pre-formulation stage, analytical tests such as hardness, disintegration performance, solubility, and release are conducted to evaluate the feasibility of the formulation.

• Process Optimization

Utilize the most advanced technology and equipment to optimize parameters, which may include adjusting the ratio of drugs and excipients and process parameters, as well as optimizing tableting processes and coating processes, etc., to further improve bioavailability.

• Critical Quality Attributes (CQAs) Assessment

Conduct stability studies in accordance with regulatory requirements to assess critical quality attributes including:

• Drug content testing.
• Moisture testing.
• Hardness testing.
• Friability testing.
• Uniformity testing.
• Solubility testing.
• Insoluble matter content testing.
• Residual solvent testing.
• Microbial testing.

Our Technology

• Coating: fluidized bed coating, hot melt coating, MAIC device, compression coating, supercritical fluid spraying, electrostatic dry coating.
• Granulation: fluidized bed coater, spray dryer, disc coater, extrusion.
• Grinding: hammer mill, jet mill, bead mill, ball mill.
• Particle size reduction: jetting and nano grinding.
• Amorphous solid dispersions: powder engineering technology.

Why Choose CD Formulation for IR/ER/MR Tablet Development?

• Extensive expertise in the development of multiple tablet types, including conventional tablets, mini tablets, enteric-coated tablets, ODT, double-layer matrix tablets, multilayer tablets, and sustained-release tablets, etc.
• Innovative sustained-release oral formulation platform and advanced technical support.
• The ability to flexibly customize the release curve for improving existing formulas, thus meeting specific treatment requirements.
• End-to-end services, from pre-formulation research to clinical trial drug production.

With our capabilities in formulation development and expertise in IR/ER/MR tablets for a wide range of APIs, CD Formulation can help you overcome solubility and release challenges for conventional tablets. Please contact us today to learn more about our services and how we can support your drug development needs.