Dose accuracy and injection force of disposable pens delivering pramlintide for the treatment of diabetes.
BACKGROUND
The pen injection format, typically used for insulin administration, has been adapted for the injectable, noninsulin diabetes therapy pramlintide. Administered before major meals, pramlintide therapy requires two to four injections/day in addition to the patients' usual insulin injections. The dose accuracy and injection force was determined for the 60 and 120 µg pramlintide pens.


METHODS
Dose accuracy testing was conducted at two sites on multiple 60 µg (15, 30, and 60 µg doses) and 120 µg pens (60 and 120 µg doses) at prespecified temperatures (5-40 °C) and humidities (0-75%) using 29 G half-inch needles. All pens were stabilized under testing conditions for 4 h prior to testing. One site used a compression load cell (Zwick device) to test pens; one site performed tests manually. Injection-force testing was conducted at one site on multiple 60 and 120 µg pens at multiple temperatures (18-28 °C) and humidities (25-75%) using 29 and 31 G half-inch needles and an injection speed of 150 m/min. Injection-force testing was performed using a Zwick device.


RESULTS
Dose accuracy for all pens tested, regardless of location, reproducibly met/exceeded acceptance criteria. Mean percentage of dose accuracy was 96.04 to 102.45% [standard deviations (SDs) 0.3 to 1.4 µg] for the 60 µg pen and 98.16 to 101.83% (SDs 0.4 to 2.5 µg) for the 120 µg pen. The average injection force across both pens did not exceed 7 N regardless of needle size.


CONCLUSIONS
High dose accuracy and low injection force were observed for the 60 and 120 µg pens under a variety of conditions.
Amylin Pharmaceuticals, Inc., San Diego, California 92121, USA. douglas.merritt@amylin.com
Douglas
D
Merritt
Barb
B
Schreiner
Scott
S
Harris
Mary Beth
MB
DeYoung
Susan
S
Strobel
Joseph
J
Lauinger
D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D002140:California; D003920:Diabetes Mellitus / Q000097:blood / Q000188:drug therapy*; D004209:Disposable Equipment; D016503:Drug Delivery Systems / Q000295:instrumentation*; D004867:Equipment Design; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007279:Injections, Subcutaneous; D058228:Islet Amyloid Polypeptide / Q000008:administration & dosage*; D008422:Materials Testing; D013557:Switzerland
D015415:Biomarkers; D001786:Blood Glucose; D007004:Hypoglycemic Agents; D058228:Islet Amyloid Polypeptide; C105254:pramlintide