Main types of Combination Products for injectable biologics:

Wearable Injectors: These devices are worn on the body and can automatically administer drugs over time, useful for treatments that require multiple doses, like biologics.

Syringes: The most common and basic injectable device, often prefilled with medication. They can be manual or powered, and come in various sizes for different volumes.

Pens and Auto-Injectors: These are user-friendly devices designed for self-administration. They allow patients to inject drugs like insulin or biologics with ease and precision. Auto-injectors typically include a spring mechanism to automatically inject the medication after the device is positioned.

Microneedle Arrays: A newer form of injectable device that uses tiny needles to deliver drugs through the skin without causing significant pain or discomfort. These are being researched for vaccines and other biologics.

Infusion Pumps: These are electronic or mechanical devices designed for continuous or intermittent administration of medication, such as insulin pumps or pain pumps for chronic conditions.

1. Syringes: The most common and basic injectable device, often prefilled with medication. They can be manual or powered, and come in various sizes for different volumes.
2. Pens and Auto-Injectors: These are user-friendly devices designed for self-administration. They allow patients to inject drugs like insulin or biologics with ease and precision. Auto-injectors typically include a spring mechanism to automatically inject the medication after the device is positioned.
3. Microneedle Arrays: A newer form of injectable device that uses tiny needles to deliver drugs through the skin without causing significant pain or discomfort. These are being researched for vaccines and other biologics.
4. Infusion Pumps: These are electronic or mechanical devices designed for continuous or intermittent administration of medication, such as insulin pumps or pain pumps for chronic conditions.
5. Wearable Injectors: These devices are worn on the body and can automatically administer drugs over time, useful for treatments that require multiple doses, like biologics.

Key Benefits of Combination products

Key benefits of injectable drug delivery devices include precise dosing, faster drug absorption compared to oral medications, and the ability to deliver large molecules (e.g., proteins, monoclonal antibodies) that would otherwise be degraded in the digestive system. However, challenges include the need for proper training, potential discomfort, and the risk of infections or injuries if not used correctly.

Overall, injectable drug delivery devices enhance patient compliance, particularly for chronic conditions requiring regular treatment, and are essential in modern medicine for various therapies.

How to select the right combination product for your drug product?

Selecting the right combination products for biologics is a crucial step in ensuring that your biologic product achieves its intended therapeutic effect while meeting regulatory, safety, and market needs. Combination products typically consist of a biologic drug, a device (like an injector or pen), and sometimes a delivery system (e.g., a device for controlled release). The goal is to optimize patient experience, compliance, and clinical outcomes.

Here are key steps to help guide your decision-making process:

 

Key Benefits of Combination products

Key benefits of injectable drug delivery devices include precise dosing, faster drug absorption compared to oral medications, and the ability to deliver large molecules (e.g., proteins, monoclonal antibodies) that would otherwise be degraded in the digestive system. However, challenges include the need for proper training, potential discomfort, and the risk of infections or injuries if not used correctly.

Overall, injectable drug delivery devices enhance patient compliance, particularly for chronic conditions requiring regular treatment, and are essential in modern medicine for various therapies.

How to select the right combination product for your drug product?

Selecting the right combination products for biologics is a crucial step in ensuring that your biologic product achieves its intended therapeutic effect while meeting regulatory, safety, and market needs. Combination products typically consist of a biologic drug, a device (like an injector or pen), and sometimes a delivery system (e.g., a device for controlled release). The goal is to optimize patient experience, compliance, and clinical outcomes.

Here are key steps to help guide your decision-making process:

Understand the Intended Use and Clinical Requirements

• Therapeutic area: Consider the disease or condition your biologic is targeting. What are the specific delivery needs for that population? For example, the patient with rheumatoid arthritis, can’t apply a lot of force to remove a cap or press a button.
• Administration route: Is the biologic administered subcutaneously (SC), intramuscularly (IM), intravenously (IV), or via another route? Typically, IV, IM administration is performed by health care practitioners while there are many devices available for home administration of SC drug products.
• Dosage frequency: A biologic that requires frequent injections may need a user-friendly device for self-administration, while long-acting biologics might be more suitable for infusions with specialized equipment.
• Patient demographics: Consider patient age, health status, and potential dexterity or cognitive challenges. Pediatric, geriatric, and immunocompromised patients might have additional needs.

Further Device Selection Criteria

• Ease of use: The device should be easy for the target patient population to use effectively, especially if self-administration is expected.
• Compatibility with biologic: Ensure the device is compatible with the viscosity, pH, and other physical properties of your biologic product. For example, biologics with complex structures or high viscosity might need specialized delivery systems (e.g., autoinjectors, prefilled syringes).
• Sterility and stability: Devices must ensure the biologic is delivered under sterile conditions, without compromising its stability.
• Safety features: Look for devices that incorporate features to minimize risks like needle-stick injuries, dose errors, or over-injection.
• Cost considerations: Evaluate the tradeoff between a more complex device (higher upfront cost) and a simpler, potentially less expensive option, especially in terms of patient compliance, which can impact long-term treatment success.

Related materials

Read more on combination products design & development, prefilled syringes, autoinjectors and wearables.