ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference...

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

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.

Dosage Forms of Choice


One Solution Fits It All?

The Steakholders


• PayersReg. Authorities •

Pharm.

Industry

•

Doctors • • Caregivers

• Patients

For all those: it is a film that makes sense


compliance adherencepatient journey convenience effective

Oral Thin Films


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

Raise your hands


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)

The Rapidfilm® and the Mucofilm®


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

The Mucofilm®


.. in details

Components of Films


Conventional

Pharma Grade

GMP

monographed

PIP-safe

WHICH PATIENTS WILL BENEFIT FROM OUR ORAL FILM

TECHNOLOGY?

.

Children (our children; the pediatric population)

.

• 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

Patient Population: Children


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

Clinical Results


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.

Adults (You and I)

.

Other examples


The migraine patient

Fast onset

The unconscious (overdosed / convulsive) patient

Fast onset + access to patient

A case study


TPP:

- Accessible to

patient`s buccal

pocket

- Quick release / fast

tmax

- Stable at various

conditions

- ….An overdosed patient

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

https://orcid.org/0000-0003-3263-4545

https://orcid.org/0000-0002-3631-5114

https://orcid.org/0000-0002-8174-2879

https://orcid.org/0000-0001-8628-8364

A case study


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)

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 -

Seniors (our parents; the geriatric population)

.

Pediatrics / Geriatrics


Analogies exist

MORE SPECIAL PATIENTS

USE CASE: PARKINSON‘S DISEASE „OFF PERIODES“

.

USE CASE: PARKINSON‘S DISEASE „OFF EPISODES“


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



Apomorphine – Subcutaneous delivery

myIV.com, website, 2019

Healthunlocked.com, website, 2019



Apomorphine – buccal transmucosal delivery

Sunovion.com, website, 2019

The Market

Exemplary Marketed Oral Thin Films


… and some more to come

• Within 2 yrs: 55 % of market share!

• 1,8 Bio USD in 2017

• Most preferred dosage form of treatment

Raise your hands


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)

Tesa Labtec – a Beiersdorf Company


125 years of experience in …

• coating technology

• development of adhesive masses and innovative

product solutions

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

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

Current & Possible Indications


Parkinson`s

Local therapy

Anti-epileptic

Migraine

Erectile

DysfunctionAnti-Anxiety

Breakthrough

Pain

….and many more

Anti-Allergic

Anti-Emetic

Alzheimer’s

Disease

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

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.

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ORAL THIN FILMS - WHY THE MUCOFILM® AND THE … · ODF > syrup (over all age groups) Difference...

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