oral thin films - why the mucofilm® and the … · odf > syrup (over all age groups) difference...
TRANSCRIPT
![Page 1: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/1.jpg)
ORAL THIN FILMS -
WHY THE MUCOFILM® AND THE RAPIDFILM® ARE EXACTLY WHAT YOU NEED
Dr. Ahmad Ghoniem – tesa Labtec – your global CDMO for patches and films – by your side from iea to market
![Page 2: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/2.jpg)
Raise your hands
9/11/2019DDF Summit, Boston, 2019 - 2 -
A: Yes
B: No
Question: Do oral thin films have an added value over
conventional tablets?
vs.
![Page 3: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/3.jpg)
Dosage Forms of Choice
9/11/2019DDF Summit, Boston, 2019 - 3 -
One Solution Fits It All?
![Page 4: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/4.jpg)
The Steakholders
9/11/2019DDF Summit, Boston, 2019 - 4 -
• PayersReg. Authorities •
Pharm.
Industry
•
Doctors • • Caregivers
• Patients
![Page 5: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/5.jpg)
For all those: it is a film that makes sense
9/11/2019DDF Summit, Boston, 2019 - 5 -
compliance adherencepatient journey convenience effective
![Page 6: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/6.jpg)
Oral Thin Films
9/11/2019DDF Summit, Boston, 2019 - 6 -
Fast dissolving oral dispersible films - No swallowing
- No water required
- Perfect for children and the elderly
Buccal and sublingual films - Fast onset of action
- Ease of use
- No first pass effect
![Page 7: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/7.jpg)
Raise your hands
9/11/2019DDF Summit, Boston, 2019 - 7 -
Question: the oral thin film is
mostly useful for:
C: Systemically acting alternatives to
orally bioavailable drugs administered
per orally (e.g. a tablet)
B: Systemic treatment while
circumventing first-pass metabolism
(for poor orally bioavailable drugs)
A: Local treatment (orally, no systemic
absorption)
![Page 8: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/8.jpg)
The Rapidfilm® and the Mucofilm®
9/11/2019DDF Summit, Boston, 2019 - 8 -
Types, Designs, Number of Layers
Typical design of tesa`s Rapidfilm® and Mucofilm®
Orodispersible film (Ph.Eur., EMA) Soluble film (FDA):
Oral film, thin strip, flash-release wafer, quick-dissolve film, orally
dissolving film, rapidly dissolving film
Variable:
- Size
- API loading
- Number of layers
- Dissolution duration
- Site of application
![Page 9: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/9.jpg)
The Mucofilm®
9/11/2019DDF Summit, Boston, 2019 - 9 -
.. in details
![Page 10: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/10.jpg)
Components of Films
9/11/2019DDF Summit, Boston, 2019 - 10 -
Conventional
Pharma Grade
GMP
monographed
PIP-safe
![Page 11: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/11.jpg)
WHICH PATIENTS WILL BENEFIT FROM OUR ORAL FILM
TECHNOLOGY?
.
![Page 12: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/12.jpg)
Children (our children; the pediatric population)
.
![Page 13: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/13.jpg)
• Uncooperative patients
• Poor tolerability from patients ( „you have one try“..)
• Risk of spitting out – dose not guaranteed
• Risk of aspiration and chocking
• Consumption of tablets not possible
• Some children have no access to clean water for
intake
• Difficulties in dosing and handling
• Variety in age, size and weight from preterm neonates
to young adults
• Ingredients have to be suitable for children‘s medicine
Children as patients
- 13 -
What is to be considered
9/11/2019DDF Summit, Boston, 2019
• Children are a special target
population with special needs
• They are not young adults
• Swallowability is a topic
![Page 14: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/14.jpg)
Patient Population: Children
9/11/2019DDF Summit, Boston, 2019 - 14 -
USE CASE: ACCEPTABILITY OF FILMS FOR TREATING NEONATES AND INFANTS
Clinical trial using placebo films developed and manufactured by tesa Labtec
150 patients aged 2 days – 12 months
To investigate the acceptability,
swallowability and palatability of placebo
ODF (2 x 3 cm) in comparison to glucose
syrup 15 % in children aged 2 days to 12
months
Prospective, single-centre, open, randomised, single dose, age-
stratified two-way cross-over design with three age sub-groups
![Page 15: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/15.jpg)
Clinical Results
9/11/2019DDF Summit, Boston, 2019 - 15 -
ODF > syrup (over all age groups)
Difference 14.7 % (95 % CI 7.91-21.43),
p < 0.0001
0
20
40
60
80
100
ODF Syrup
Acceptability over all age groups
ODF > syrup
Difference 21.3 % (95 % CI 11.11-31.55),
p < 0.0001
0
20
40
60
80
100
ODF Syrup
Swallowabilityover all AGs
Palatability
Assessments are in favour
of the ODF because the
rates of “unpleasant”
judgments were clearly
smaller for ODF than for
syrup.
![Page 16: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/16.jpg)
Adults (You and I)
.
![Page 17: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/17.jpg)
Other examples
9/11/2019DDF Summit, Boston, 2019 - 17 -
The migraine patient
Fast onset
The unconscious (overdosed / convulsive) patient
Fast onset + access to patient
![Page 18: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/18.jpg)
A case study
9/11/2019DDF Summit, Boston, 2019 - 18 -
TPP:
- Accessible to
patient`s buccal
- Quick release / fast
tmax
- Stable at various
conditions
- ….An overdosed patient
![Page 19: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/19.jpg)
USE CASE: SILDENAFIL CITRATE ORODISPERSIBLE FILM
DDF Summit, Boston, 2019
Bioequivalence Study ( IBSA )
- 19 -
Irma Cupone, Fabio Marra, Eleonora Deller, Simona Gianella, Andrea Giori ( IBSA )
Fact sheet
API Sildenafil citrate
Indication Erectile Dysfunction
Dosage form 100 mg orodispersible
film
Authors Radicioni M, Castiglioni C, Giori A, Cupone I,
Frangione V, Rovati S
9/11/2019
![Page 20: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/20.jpg)
A case study
9/11/2019DDF Summit, Boston, 2019 - 20 -
Oral lesions
TPP:
- reside 30 min locally
- API release uni-
directionally
- No systemic
absorption
- Refreshing taste
- Fixed size vs. flexible
size
- ….
- Bi-layer
- Formulation development on both layers (acrtive, placebo backing)
- Processability / scale-up
- Clinical trial supplies (CTS)
![Page 21: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/21.jpg)
3 scales, 2 sites, 1 aim: your success
All scales under GMP conditions; both sites FDA approved
1
2
3
Lab s
cale
Pilo
t scale
Com
merc
ial scale
All scales:
GMP
FDA
XXX - 21 -
![Page 22: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/22.jpg)
Seniors (our parents; the geriatric population)
.
![Page 23: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/23.jpg)
Pediatrics / Geriatrics
9/11/2019DDF Summit, Boston, 2019 - 23 -
Analogies exist
![Page 24: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/24.jpg)
MORE SPECIAL PATIENTS
USE CASE: PARKINSON‘S DISEASE „OFF PERIODES“
.
![Page 25: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/25.jpg)
USE CASE: PARKINSON‘S DISEASE „OFF EPISODES“
9/11/2019DDF Summit, Boston, 2019 - 25 -
Treatment of off episodes with apomorphine
Managing PD Mid-Stride – A Treatment Guide to Parkinson‘s Disease, Parkinson‘s Foundation
Apomorphine, Drugbank.ca
S. Gancher, Pharmacokinetics of apomorphine in Parkinson’s disease,
J. Neural Transm. Suppl. 45 (1995) 137–141.
M.J. Tsai, Y.B. Huang, P.C. Wu, Y.S. Fu, Y.R. Kao, J.Y. Fang, et al., Oral apomorphine delivery
from solid lipid nanoparticles with different monostearate emulsifiers: pharmacokinetic and
behavioral evaluations, J. Pharm. Sci. 100 (2) (2011) 547–557
Characteristics
Half life 33 min
MW 267 Da
Oral BA <2%
logP 3.1
pKa 8.9
![Page 26: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/26.jpg)
USE CASE: PARKINSON‘S DISEASE „OFF EPISODES“
9/11/2019DDF Summit, Boston, 2019 - 26 -
Apomorphine – Subcutaneous delivery
myIV.com, website, 2019
Healthunlocked.com, website, 2019
![Page 27: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/27.jpg)
USE CASE: PARKINSON‘S DISEASE „OFF EPISODES“
9/11/2019DDF Summit, Boston, 2019 - 27 -
Apomorphine – buccal transmucosal delivery
Sunovion.com, website, 2019
![Page 28: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/28.jpg)
The Market
![Page 29: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/29.jpg)
Exemplary Marketed Oral Thin Films
9/11/2019DDF Summit, Boston, 2019 - 29 -
… and some more to come
• Within 2 yrs: 55 % of market share!
• 1,8 Bio USD in 2017
• Most preferred dosage form of treatment
![Page 30: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/30.jpg)
Raise your hands
9/11/2019DDF Summit, Boston, 2019 - 30 -
Question: the oral thin film is
mostly useful for:
C: Systemically acting alternatives to
orally bioavailable drugs administered
per orally (e.g. a tablet)
B: Systemic treatment while
circumventing first-pass metabolism
(for poor orally bioavailable drugs)
A: Local treatment (orally, no systemic
absorption)
![Page 31: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/31.jpg)
Tesa Labtec – a Beiersdorf Company
9/11/2019DDF Summit, Boston, 2019 - 31 -
125 years of experience in …
• coating technology
• development of adhesive masses and innovative
product solutions
![Page 32: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/32.jpg)
tesa Labtec: by your side, from idea to market
2 sites, 3 scales, but 1 aim: YOUR SUCCESS
Dosage Forms:
By your side: from idea to market
Regardless of
• colors
• shapes
• number of layers
• type of polymers
• type of applications
DDF Summit, Boston, 2019 - 32 - 9/11/2019
Quality made in Germany
FDA inspected cGMP
Europe
Manufacturing facility
supports lab-scale-to-pilot
and commercial-scale
production
![Page 33: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/33.jpg)
Our partners
tesa Labtec: your innovative driven CDMO
Your one-stop-shop – from the idea to the market
full regulatory support serviceformulation services
process services
manufacturing services
one stop-
shopping
DDF Summit, Boston, 2019 - 33 - 9/11/2019
![Page 34: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/34.jpg)
Current & Possible Indications
9/11/2019DDF Summit, Boston, 2019 - 34 -
Parkinson`s
Local therapy
Anti-epileptic
Migraine
Erectile
DysfunctionAnti-Anxiety
Breakthrough
Pain
….and many more
Anti-Allergic
Anti-Emetic
Alzheimer’s
Disease
![Page 35: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/35.jpg)
THANK YOUE-Mail: [email protected]
Internet: www.tesa-labtec.com
Phone: 1-877-309-0092 (toll free)
tesa Labtec GmbH
Dr. Ahmad Ghoniem
Manager Business Development
North America
![Page 36: ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference 14.7 % (95 % CI 7.91-21.43), p < 0.0001 0 20 40 60 80 100 ODF Syrup Acceptability](https://reader034.vdocument.in/reader034/viewer/2022042215/5ebb9dfbd435d30ec7073cf3/html5/thumbnails/36.jpg)
tesa® products prove their impressive quality day in, day out in demanding conditions and are regularly subjected to strict controls. All technical information and data above mentioned are provided to the best of our knowledge on the basis of our practical
experience. They shall be considered as average values and are not appropriate for a specification. Therefore tesa SE can make no warranties, express or implied, including, but not limited to any implied warranty of merchantability or fitness for a particular
purpose. The user is responsible for determining whether the tesa® product is fit for a particular purpose and suitable for the user’s method of application. If you are in any doubt, our technical support staff will be glad to support you.