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Penn-Century DP-4_4M User Manual

Page 7

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7

RECOMMENDATIONS FOR USE OF PENN-CENTURY DRY POWDER INSUFFLATORS™

First time use: New users are encouraged to practice with the device by loading a volume of inhalation

grade lactose that is similar to the volume they plan to use in their final study. Practicing using it in the

open air will give a sense of how fast and hard the plunger of the air syringe or Air Pump must be pushed

to produce a cloud of particles. If using the air syringe, it is necessary to first set the plunger using the

measurement marks on the syringe to deliver the proper volume setting for the animal to be used. The

user must push the plunger quickly and firmly to produce a cloud of particles. If using the Air Pump,

normal thumb pressure is sufficient and the thumb button will return to the start position automatically.

NOTE: The device is tested with inhalation grade lactose prior to shipping. Trace amounts of powder

may be on the device when first opened.

Characteristics of use with dry powder formulations: Penn-Century Dry Powder Insufflators™ have

been successfully used with a wide range of pharmaceutical, biologic and toxicological compounds. The

Penn-Century Dry Powder Insufflator™ does not filter or alter the powder formulation and can

accommodate a very wide range of powder particle sizes from nanoparticle formulations to large porous

particles. Dry powder formulations vary widely in their characteristics. Some powders may absorb

ambient humidity more rapidly than others. In such cases, the entire device may be loaded in a glove

bag to keep it from exposure to air. Once the device is loaded and the two halves are reattached,

exposure to air is very minimal.

Dose volume capacity of Model DP-4: The Model DP-4 is designed for precise administration of

powder doses in the range of 1-5 mg. For larger doses, the user may purchase a 100 mg Sample

Chamber Extension. Regardless of the dose capacity of the device, the dose is intended to be loaded

with one dose per use. It is not intended to be filled with a larger volume of powder in order to dose

smaller amounts to several animals in sequence

.

Dose volume capacity of Model DP-4M: The Model DP-4M is designed for precise administration of

powder doses in the range of 1-2 mg. It is intended to be loaded with one dose per use. It is not

intended to be filled with a larger volume of powder in order to dose smaller amounts to several animals

in sequence

.

Static electricity – Effect on powder sample: It is important to note that the device is made of non-

conductive materials which can build up a slight electrostatic charge that can interact with the powder

samples and cause the internal surfaces to acquire a light coating of powder. This coating can add a

milligram or more to the tare weight of the device. For this reason, the device should be loaded and

discharged several times before starting an experiment in order to allow electrostatic effects to become

saturated. Once the internal surfaces are coated, the device will be relatively stable gravimetrically. Tare

weight variations of the stabilized device are on the order of 50-100μg. It is not necessary to remove

all traces of powder between each use, as this may refresh the static properties of the

device. The optimal sample delivery efficiency is achieved (nearly 100% with lactose) after two or three

deliveries, when the static electrical effects have become saturated.

Quantifying dry powder dose delivery: Because the devices are light, it is possible to precisely

quantify the delivered dose, unlike passive exposure systems. To do this, the user must weigh the

device before and after loading, using a precision balance or scale.

Preparing to load the Dry Powder Insufflator™: The Model DP-4 and DP-4M each consist of two

halves: an Air Intake and the Sample Chamber. The Sample Chamber is the portion of the device that is

attached to the delivery tube. Separate the two parts with a simple “twist-and-pull” motion. On rare

occasions, the two halves may stick together and cannot be twisted apart. If this occurs, grasp the two

parts firmly with your finger tips close to the point where they meet and gently rock your hands up and

down in unison – as if you were attempting to break the device in half. This usually immediately releases

the two halves.