Abstract
I. Background: Release liner removal from adhesive films is a newly introduced Pharmacopoeial test.
Release liner should detach easily and completely from the adhesive.II. Aims : To examine
whether and how drug loading in adhesive films affects removal (peel) of the release liner from the
adhesive film; and to correlate peel forces with film viscoelastic properties.III. Methods: Acrylic
(DURO-TAK 87-4287) films at ibuprofen concentrations of 0%, 5%, 15% & 25% (w/w) were prepared
in triplicate. Viscoelastic measurements of the bulk adhesive were performed at 32°C using a Bohlin
Gemini rheometer with a 20mm stainless steel parallel plate and 1mm gap size. The peel force to detach
the release liner (Scotchpak 9742) from the adhesive film was measured at a constant rate of 300mm/min
at an angle of 90° using a Zwick Z010 material tester. Microscopic examination of the films was
undertaken using an Olympus BH2 polarised microscope with an Olympus 10x lens fitted with a camera
(AxioCam MRc-Zeiss, UK) and AxioVision v4.4 image analyser software.IV. Results: Films containing 5%
w/w ibuprofen were unsaturated, whereas films at 15% and 25% w/w ibuprofen concentrations contained
undissolved drug. Peel force to remove the release liner was lowest for the unmedicated films and highest
for the 5% w/w ibuprofen films. Viscoelastic measurements showed softening of the adhesive at 5% w/w
compared to the unmedicated film, followed by gradual film strengthening at the saturated
concentrations.V. Summary / Conclusions: Addition of drug in the adhesive at unsaturated concentrations
(5% w/w) caused film softening and subsequent increase in the force required to remove the release liner.
Release liner should detach easily and completely from the adhesive.II. Aims : To examine
whether and how drug loading in adhesive films affects removal (peel) of the release liner from the
adhesive film; and to correlate peel forces with film viscoelastic properties.III. Methods: Acrylic
(DURO-TAK 87-4287) films at ibuprofen concentrations of 0%, 5%, 15% & 25% (w/w) were prepared
in triplicate. Viscoelastic measurements of the bulk adhesive were performed at 32°C using a Bohlin
Gemini rheometer with a 20mm stainless steel parallel plate and 1mm gap size. The peel force to detach
the release liner (Scotchpak 9742) from the adhesive film was measured at a constant rate of 300mm/min
at an angle of 90° using a Zwick Z010 material tester. Microscopic examination of the films was
undertaken using an Olympus BH2 polarised microscope with an Olympus 10x lens fitted with a camera
(AxioCam MRc-Zeiss, UK) and AxioVision v4.4 image analyser software.IV. Results: Films containing 5%
w/w ibuprofen were unsaturated, whereas films at 15% and 25% w/w ibuprofen concentrations contained
undissolved drug. Peel force to remove the release liner was lowest for the unmedicated films and highest
for the 5% w/w ibuprofen films. Viscoelastic measurements showed softening of the adhesive at 5% w/w
compared to the unmedicated film, followed by gradual film strengthening at the saturated
concentrations.V. Summary / Conclusions: Addition of drug in the adhesive at unsaturated concentrations
(5% w/w) caused film softening and subsequent increase in the force required to remove the release liner.
| Original language | English |
|---|---|
| Number of pages | 1 |
| Publication status | Published - 5 Oct 2012 |
| Externally published | Yes |
| Event | FIP Congress 2012 - Amsterdam, Netherlands Duration: 3 Oct 2012 → 8 Dec 2012 |
Conference
| Conference | FIP Congress 2012 |
|---|---|
| Country/Territory | Netherlands |
| City | Amsterdam |
| Period | 3/10/12 → 8/12/12 |