Sharp was approached to develop a package for an intramuscular injectable used for the treatment of schizophrenia. The Sharp team partnered with the customer during many stages of the product packaging development, including clinical trials, human factor studies, packaging samples, tray samples, shipment studies, carton design and thermoform design.

The Challenge Identified

The challenge was to create a design for a multi-component packaged kit, in three different dose strengths for the new extended-release intra-muscular injectable, used in the treatment of schizophrenia. A critical deliverable in the functionality of the packaging was to ensure user compliance in administration. Effective preparation is crucial to ensuring a successful outcome. The physician must follow a specific procedure in order to administer effectively. The product syringe needs to be shaken and tapped on the tip a specific number of times to prevent clogging and a malfunction in the administration of the drug. This added an extra layer of complexity to the design brief.

The Sharp Solution

To communicate the usage instructions effectively we developed several key features for compliance. The complete packaged kit, as designed by Sharp, is composed of:

  1. A top opening design to have better visibility of the components and the order they need to be used
  2. Text on the inside of the carton lid directing a review of the IFU instructions
  3. A modified tray design to hold an insert card further emphasizing the critical need to adhere to the instructions.

In total, Sharp designed the outer carton, reverse tear lid, the custom-designed interior thermoform tray, the snap-fit safety instruction card, the inner sealed section housing 2 or 3 needles and patient information. The packaging presents each component of the kit individually in a staged sequence to ensure compliance with the instructions.

The packaging had to be both accessible and easy to use by the healthcare administrator. It also had to be cost-effective to print and assemble in the commercial phase. Other considerations were for the package to be optimally designed for shipping (it passed ASDM ship testing), distribution and presentation on the shelf. The three different dosage levels needed to be identifiable as one brand but clearly distinguishable from each other.

Extensive Human Factor Studies were performed with these modifications to measure compliance and positive execution of the step-by-step procedure for administration of product to the patient.

The Positive Outcome

The Sharp design team began working with the customer at the clinical trial stage and we leveraged that knowledge to evolve the design and build of the packaging for the commercial launch of the product.

The Patient Impact

The successful dosing and administration of this injectable is inextricably linked to the presentation and preparation instructions as designed into the complete packaged kit.

Sharp offers the expertise, flexibility and capacity for injectables assembly, labeling, packaging and serialization in both our Belgium and Allentown facilities.