Pen injectors

Where there is a dosing device provided with the product, the dose reproducibility and accuracy should be demonstrated. Examples include dropper devices, dose-measuring devices, and pen injectors. The instructions for use should also be discussed for such devices and may be particularly important for devices such as two-chamber cartridges and the like containing suspension products. It might be necessary to discuss how dosing devices meet the relevant Essential Requirements of the Medical Device Directives with reference to appropriate and relevant harmonized and other European (EN) and International Standards Organization (ISO) standards. 

Container composition and tamper evidence is discussed in the EPARs. There is also discussion of containers in cases where special systems such as two-compartment cartridges are used. Any particular points relating to multiple withdrawals of doses from the container will also be included. Special issues relating to pen injectors will be included. 

Lteif AN, Schwenk WF. Accuracy of pen injectors versus insulin syringes in children with type 1 diabetes. Diabetes Care 1999 22(l) 137-40. 

Specific considerations for container/closure system components for specialized delivery systems such as metered dose inhalers, dry-powder inhalers, disposable pen injectors, transdermal patches, or other novel dosage forms... 

A novel biologic administered using a 510(k) cleared pen injector... 

Figure 8-1 Dial and pen injectors for insulin (on the same scale)...

The present summary will cover only those technologies where the drug formulation itself is used to penetrate the skin via its mechanical energy. It will not describe any technology where a needle is used to puncture the skin, even if the needle is not visible to the patient or only the epidermis is punctured, such as mini-needles, microneedles, pen injectors, or autoinjectors. Also excluded are systems that ablate the skin mechanically or otherwise disrupt its chemical or mechanical structure to increase its permeability, such as laser ablation, microdermal ablation, electroporation, or iontophoresis. These are usually referred to as transdermal drug delivery, but can also be described as needle free. 

Establishing clinical bioequivalence to a reference delivery method, usually a needle and syringe or an autoinjector or pen injector is the customary method of demonstrating that these conditions have been successfully met. This requires that the maximum blood plasma concentration of the drug (Cmax) and the total area under the time-concentration curve (AUC), as well as their associated confidence intervals, adequately approximate a reference product. The standard criteria to establish bioequivalence are 70-143% for Cmax and 80-125% for AUC (Fig. 3 for an example of a bioequivalent needle-free delivery). 

The nurse is teaching the client with Type 1 diabetes how to use an insulin pen injector. Which information should the nurse discuss with the client ... 

Discuss that the insulin pen injector must be used in the abdominal area only. 

The insulin pen injector does not require drawing up insulin in a syringe. 

The insulin pen injector can be used in any subcutaneous site that traditional insulin can be injected. 

A disposable pen-injector where the drug-containing injector is a single integral unit and only to be used in that given combination, is covered by the MPD. However in addition to this, the relevant essential requirements in Annex 1 of the MDD apply with respect to safety and performance related features of the device (e.g. a syringe forming part of such a product). 

For a drug-containing pen injector that is developed for a specific drug, but whereby the device and drug are available separately, the device and the drug will be considered individually as a medical device and a medicinal product (MDD and MPD applied, respectively). 

There are a significant number and variety of pen-injector devices on the market and in development today, including products for treatment of diabetes, rheumatoid arthritis, and growth hormone deficiency. These pen-injector devices are generally... 

The device is available as a marketed product and the drug that is to be inserted into the pen-injector device is purchased by the patient separately. Here the combination is undertaken by the patient, not by the manufacturer. 

The drug and device are combined during the manufacturing or assembly process and the patient receives the product as an integrated drug-containing pen-injector device. 

Whether the contact is transient (e.g., only during injection) or sustained during the patient use period (e.g., over the entire period the cartridge remains within the pen-injector)... 

Bak,J. F.,Nielson, 0. H., Pederson, 0.,andBeck-Nielsan,H., 1987, Multiple insulininjections using a pen injector versus pump treatment in young diabetic patients. Diabetes Res. 6 155-158. 

GaU, M.-A., Mathiesen, E. R., Skott, P., Musaeus, L., Damm, S., Beck-Nielsen, H., and Parving, H.-H., 1989, Effect of multiple insulin injections with a pen injector on metabolic control and general well-being in insulin-dependent diabetes mellitus. Diabetes Res. 11 97-101. 

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