Pellet Development Services

Pellets are small solid, spherical, or cylindrical particles containing a specific dose of drug. They are commonly used in pharmaceutical manufacturing and are designed to release the drug in a controlled manner over an extended period. This controlled release mechanism allows for continuous drug delivery, ensuring consistent therapeutic effects and reducing the frequency of administration.

Pellets are typically used in oral dosage forms, such as capsules or tablets. They can also be filled into capsules for modified-release applications or incorporated into other drug formulations such as transdermal patches or implants.

Protheragen-ING provides pharmaceutical companies and research organizations with comprehensive pellet development services to meet their specific drug development needs. Our experienced team of scientists and engineers specializes in the formulation, optimization, and manufacturing of pellets for controlled-release applications.

Advantages of Pellets

• Pellets provide more uniform drug distribution, which can improve drug absorption and reduce inter-individual variability in drug response.
• The controlled-release nature of pellets can improve patient compliance by reducing the frequency of administration and minimizing side effects associated with peak drug concentrations.
• Pellets provide flexibility in dosing regimens because they can be formulated to release the drug immediately, with a delayed onset, or in a pulsatile manner.

Technology for Manufacturing Pellets

Protheragen-ING is made by mixing an active pharmaceutical ingredient (API) with other excipients and binders to form a homogeneous mixture. The mixture is then processed using various techniques to form pellets. The choice of manufacturing method depends on the specific drug and the desired release profile.

• Direct pelletizing
• Pelletizing by powder layering
• Solution suspension layering technique
• Fluidized bed granulation
• Extrusion pelletizing
• Roller pelletizing
• Coating technology
• Laminating

Key Steps in Our Pellet Development Process

• Determination of target properties and performance requirements for pellets - drug release characteristics, stability requirements, drug concentration, target particle size and shape, etc.
• API selection and preparation - powdering, screening, and mixing of API, etc.
• Selection of granulation technology suitable for the target drug and development and optimization of the granulation process - determination of suitable binder, excipients and process parameters such as extrusion speed, spray rate of spray liquid, drum speed, etc.
• Preparation and optimization of pellets based on the selected granulation process - may involve adjustment of process parameters, optimization of binder and excipient formulation, control of particle size and shape, etc.
• Coating technology development (optional) - if required to control release characteristics or improve stability.
• Validation and quality control of developed pellets - assessment of physical properties (e.g., size, shape, homogeneity), testing of drug release characteristics, and stability studies.
• Industrialization and production scale-up - involves developing production processes, setting up production equipment, and operating procedures to ensure consistency and quality control in large-scale production.

Fig. 1 Pellets prepared by conventional and innovative technologies. (Kállai-Szabó N, et al. 2022)

The Cases for Pellets

Several drugs are often formulated into pills for controlled-release applications. Here are some examples:

• Methylphenidate: It is commonly formulated into pellets to provide sustained release and prolonged duration of action.
• Diltiazem: Diltiazem controlled-release pellets provide a gradual sustained release of the drug, thus maintaining stable blood levels over a longer period.
• Theophylline: Pellets of theophylline provide controlled release, ensuring a consistent therapeutic effect and reducing the frequency of administration.
• Ropinirole: Pellets of ropinirole allow for a controlled release, helping to control the symptoms of these conditions over time.
• Venlafaxine: Venlafaxine controlled-release pellets are used to provide sustained antidepressant effects and minimize side effects.
• Mesalazine: pellet formulations of mesalazine are designed for controlled release in the gastrointestinal tract to deliver the drug to the affected area.

Contact us today to discuss your project requirements and explore how we can assist you in developing high-quality drug pellets for controlled-release applications.