Oral Films Development & Manufacturing in India - Current Scenario

Dr. Sridhar Rudravarapu
Technical Consultant – Research & Product Development
Pharmaceuticals & Health Supplements
Hyderabad, INDIA
ORAL FILMS
An Alternate Convenient Dosage Delivery System
Oral Films - Development & Manufacturing in INDIA
Current Scenario
January 2018
Email: dr.r.sridhar@gmail.com Title slide

Presentation Contents
ORAL FILMS
Alternate Convenient Dosage Delivery System
Oral Films - Development & Manufacturing in INDIA – Current Scenario
Presenter: Dr. Sridhar Rudravarapu RS/Jan 2018
S.No. Content Slide No.
1 Oral films in India - Summary Slides 3-7
2 Oral films in India - Introduction 8-12
3 Oral films in India – Development & Manufacturing 13-21
4 Oral films in India – Comparative B.E. Study & Clinical Trials 22-24
5 Oral films in India – Post Marketing Surveillance 25
6 Oral films in India – CDSCO Approvals 26-27
7 Oral films in India – FSSAI Approvals 28
8 Oral films – Abroad Approvals 29-30
9 Oral films in India – Patent Application Filing 31
2 of 31

Oral Films - Current Scenario in India
3 of 31Presenter: Dr. Sridhar Rudravarapu Summary Slide – Opportunities, Constraints & Way Forward RS/Jan 2018
Opportunities:
It is nearly a decade that Oral Film (a novel drug delivery system) has been first approved for
marketing in India in the year 2008!
Since then, several oro-dispersible products developed mainly in the orally disintegrating
film/strip form have been approved for manufacturing/marketing and launched in India
(NU/Shilpa Therapeutics & Zim Labs).
Oral films mostly popular as mouth freshening forms till now are increasingly lapped up by
healthcare professionals and patients for drug/food supplement applications and a vast new
venue of opportunities lies for the enterprising pharma players in India.
Already major pharma companies (Reddy Labs/Abbott/ Cipla/ Hetero/ Mankind…) have begun
their engaging steps in the research, co-development and marketing of oral film (Oro
Dispersible/Oro Mucosal) products.
A plethora of nutraceutical/food supplement ingredients are also in chain for development in
to effective oral films.

Opportunities:
Based on biological equivalence, new oral film products developed using safe generic drug
products can be used interchangeably with the conventional oral tablet formulations.
No new non-clinical /clinical data other than B.E. study data was required for the approval of
these oral film products
Patent Applications on oral films (more than 11) filed in India are in the granted/published
status of patenting process.
Patent applications filed for sublingual films in India indicate their differentiation and higher
efficacy compared to other oral formulations in terms of oral systemic absorption, significantly
reduced drug load and avoidance of first pass effects (Inventor/Applicant details provided in the ensuing
presentation).
Numerous patent expiring drugs developed and approved as oral film application could
garner market exclusivity period given its novelty and type of application --new dosage form,
505 b(2).

Product Development:
The difficulty in incorporating water insoluble drugs, relatively smaller drug load and
sensitivity to humidity/temperature necessitates exclusive packaging for oral film products.
The rate and extent of dissolution and the target site of absorption influence the oral film
composition.
Acceptable mechanical parameters ensure flexibility and robustness of oral films during
manufacturing & handling.
Suitable methods for effective testing of in-vitro disintegration & dissolution and water
content in oral films need to be standardized for uniform application.
Pharmacopoeial Monographs for oral film products are not available globally and need to
be in place urgently for the implementation of drug quality standards and safety compliance.

Manufacturing:
Procurement of API & excipients for oral film manufacturing requires customized materials.
Sourcing of raw materials for oral film development/manufacturing in India for regulated
markets is thus demanding!
Aqueous slurry casting - widely used technique for oral film development & manufacturing.
The manufacturing process of oral films has been influenced largely by the machinery used
in India and it could evolve further for higher productivity & stringent regulatory compliance.
Closure container for oral films needs to be studied further for alternate packing materials
& cost reduction.

Regulatory:
Oral film products in India have demonstrated good stability of the product even when stored
under long term conditions for >4 years.
Dossier submissions made with the acceptable product stability and comparable biological
evaluation study results with the reference oral tablet lead to the approval of oral film products
by CDSCO-India.
Dossier submissions made by Indian manufacturers for the oral film products in the semi-
regulated (RoW) markets abroad have been receiving acceptance and on the rise.
Pharmaco-vigilance based on regular PSUR submissions made by the oral film manufacturers in
India indicates that the risk-benefit profile of the drug remains favorable in oral films.
Prices of oral film products also come under the control of National Pharmaceutical Pricing
Authority, India. For example the price for Ondansetron HCl orally disintegrating strip has been
fixed/revised under Drug Price Control Order (DPCO), 2013.

ORAL FILMS
Oral Films
Single or multilayered, mucoadhesive or non-mucoadhesive thin polymeric films
Deliver active therapeutic moieties in oral cavity
through
lingual, sublingual, buccal, or palatal surfaces
for local/gastrointestinal or systemic absorption
Oral films (Oro Dispersible & Oro Mucosal) are known variously as
- Orally disintegrating/dissolving films Rapid/fast/quick dissolving films
- Oral soluble films Oral thin films
- Buccal or buccal soluble films Mucoadhesive films
- Transmucosal films Sublingual films, etc.
8 of 31Oral Films - A Novel Drug Delivery System. An alternate, convenient oral drug delivery form. RS/Jan 2018

ORAL FILMS
Way to improved patient compliance
(especially in pediatric, geriatric, dysphagic & odynophagic patients)
Oral Films are advantageous over the conventional formulations
 Availability of larger surface area for faster wetting, disintegration, and dissolution
Clinical advantages such as dosing accuracy and flexibility
Film thickness (50-300 m); No safety/toxicity issues
Ease of administration without the necessity of water, chewing, and swallowing
Amenable to continuous film product manufacturing with robust process handling;
aqueous-based; powder less and solvent less conditions.
Ease of finished product portability and handling
9 of 31Oral Films are fast, convenient, effective and globally acclaimed. RS/Jan 2018

ORAL FILMS - TYPES
Oro Dispersible Films (ODF) & Oro Mucosal Films (OMF)
Oro Dispersible Films (ODF)
are non-mucoadhesive (Disintegrate and/or dissolve immediately in oral cavity upon contact with
saliva without involvement of water or chewing and deliver drugs locally or systemically through
gastrointestinal absorption).
Dissolution represents drug in solution (dissolved drug in saliva; in-vivo) while disintegration
represents breakage of film formulation (dispersion of film components in saliva).
Orally Disintegrating Films: Disintegrate in the oral cavity to facilitate fast dispersion in saliva
for easy swallowing and dissolution of drug in oral cavity. Dissolution and absorption of most
of the drugs in this form occurs in gastrointestinal tract.
Oro Mucosal Films (OMF)
are mucoadhesive (Adhere to sublingual, buccal, or palatal mucosa and deliver therapeutic
moieties locally or systemically; OMF must be an orally dissolving film for this purpose).
OMF can be advantageous over ODF due to their ability to bypass the first pass metabolism.
10 of 31Oral Films are classified as Oro Dispersible and Oro Mucosal Films based on their muco-adhesion. RS/Jan 2018

ORAL FILMS – DEVELOPMENT & MANUFACTURING
Drug Solubility is a Key Factor for the Development & Manufacturing of Oral Films
ODF could either be orally disintegrating or dissolving films depending on the intended site of drug
action and/or absorption. Solubility of the drug influences the formulation for disintegration or
dissolution of films in oral cavity.
Dissolution of water soluble drugs (BCS Class I/III) in mouth or oral cavity could occur simultaneously
with disintegration of films though they are designed to be absorbed in gastrointestinal tract.
Dissolution of poorly water soluble drugs (BCS Class II/IV) could be difficult due to their poor solubility,
intrinsic dissolution rate, and limited amount of saliva in the oral cavity.
Hence, the oral films containing poorly water soluble drugs are usually the orally disintegrating film
types, whose target site of dissolution and absorption is gastrointestinal tract.
Several of the oral films developed and approved in India till now belong to orally disintegrating
film/strip category.
11 of 31Need to ensure adequate solubility & fast dissolution of oral films under a wide range of physiologicalconditions. RS/Jan 2018

INDIA
Among various techniques and technologies available for oral film manufacturing, solvent casting is
widely used in India.
Aqueous slurry casting is being widely applied due to the possibility of film manufacturing without the
use of expensive and harmful solvents.
Oral films are evaluated for
Organoleptic characteristics: Appearance, size, shape, color, transparency, taste, odor, pores,
tackiness, etc.
Mechanical properties: Thickness, tensile strength, percentage elongation, tear resistance,
folding endurance, swelling property, peel-ability, weight etc.
Film stability/performance/quality attributes: Drug - assay, content uniformity, impurities,
disintegration, dissolution, residual water and/or solvent content, microbial content, etc.
12 of 31Aqueous slurry casting has been a widely used technique for oral film development & manufacturingin India RS/Jan 2018

Raw Materials for Oral Film development & Manufacturing
API : The active pharmaceutical ingredients are evaluated for heat, moisture, shear and photo
sensitivity, solubility, particle size and desired mass for casting and dosage uniformity.
The API specifications conform to the respective pharmacopoeial monographs as maintained in
the case of oral tablet/capsule formulations. But the desired particle size requirement can be
specified only after the initial R&D trials to the API suppliers for procurement. This could result in
extra cost from the suppliers.
Excipients: In general no novel pharmacopoeial excipients are required for the development of
oral films. However, the important base polymer materials, ion-exchange resins and bitter taste
masking agents are sourced from international companies with proprietary/technology rights on
the same. Cost effective indigenous manufacturing in India is desired for continuous and economic
supply of the above mentioned materials.
Another area for improvement is in the supply of substrate/support polymer film required during
the manufacturing of oral films. Due to the presence of very few suppliers in India for this
material, consistent quality supply is often felt as a constraint.
13 of 31Procurement of API & Excipients for oral film manufacturingrequires customized materials for this purpose RS/Jan 2018

Raw Materials for Oral Film development & Manufacturing
Quality Specifications
Considering slight difference between the quality specifications of API & excipient materials as per
various country pharmacopoeia, a clear understanding at the beginning of R&D stage itself is
desired to develop and manufacture oral films as per targeted country/region specific
pharmacopoeial requirements. For example oral film products developed as per IP monograph
specifications some times may vary with those of EP/USP/JP monograph specifications for the API
and excipient materials.
Another constraint in India is the availability of API suppliers compliant with requisite DMF
possession and other regulatory documentation support for external marketing. Wherever they
are compliant the next concern would be the escalated price for these materials. Sourcing of small
amounts of the compliant API materials for R&D trial purpose is very difficult due to obviously
insufficient order quantity/commitment at the initial stages and hence their supply at exaggerated
cost for the same.
In-house specifications applied for few raw materials relevant to oral film making such as flavoring,
sweetening and coloring agents also could be a concern in the absence of relevant USP/other
specifications for the same.
14 of 31Sourcing of raw materials for oral film development/manufacturing in India for regulated markets is demanding ! RS/Jan 2018

Critical Properties for Evaluation of Oral Films
Flexibility, disintegration rate, mouth feel and handling properties.
Appropriate taste/flavor profile and bitter taste masking.
Moisture content acceptable for physical properties, mechanical properties
 in-vitro disintegration and dissolution, pH and colour
Mechanical properties at appropriate level for convenient film roll manufacturability as well as for
proper handling and transportation of the finished product (This varies from one product to another,
due to the variation in composition, drug load, and dosage form design).
Thickness/viscosity of the aqueous slurry cast for layering and the rheological parameters involving
fluid flow play an important role in quality control and sensory assessment of oral films.
In the absence of pharmacopoeial monograph specifications for the oral films, the desired product
specifications are being followed as per comparative oral tablet formulation specifications in IP/USP
monographs.
15 of 31Acceptable mechanical parameters ensure flexibility and robustness of films during manufacturing& handling RS/Jan 2018

16 of 31The manufacturingprocess of oral films has been influenced largely by the machinery used in India RS/Jan 2018
Suspension characteristics,
Temperature during the process
Dispersion/Dissolution
(Excipients & API into polymer base)
Homogenization & De-aeration
Layering of Suspension
Drying
Mechanical tension & speedSlitting
Sealing characteristicsPacking
Layering characteristics, film peel-ability, Test
film-weight, dimension, thickness,
Assay & content uniformity & Moisture content
Pressure & Temperature
Polymer Base Preparation Polymer characteristics
Manufacturing Process - Solvent Casting type - A Typical Flow Chart
Process Steps Key Checks

ORAL FILMS – MANUFACTURING
Oral Film Coating Oral Film Roll Slitting
Oral Film Packaging
Equipment
Machinery used for product slurry coating, roll slitting and packaging of oral film manufacturing in
India is mostly of indigenous make customized to the manufacturing process and packaging system.
Indian manufacturers are on the way to procure effective automated oral film manufacturing systems
compliant to global regulatory specifications which are highly priced and available mainly from
Germany based sources.
17 of 31Oral film manufacturingin India needs to evolve further for higher productivity & higher regulatory compliance RS/ Jan 2018

ORAL FILMS - MANUFACTURING
Packaging/Closure Container System
18 of 31Closure container for oral films needs to be studied further for alternate packing materials & cost reduction RS/Jan 2018
Aluminum sachet is a most commonly used peel-able container system with
essentially zero transmission of both gas and moisture while providing a flexible
primary packaging of thin oral film for pharmaceutical applications in India. The
single dose sachet provides both product and dosage protection. The package
is easier for the consumer to handle and to open easily.
The oral films are packed on automated machinery using a blend of aluminum
foil and a polyester material for peel-able seals. This package material requires
specific tensile strength to resist any puncture, heat impact, tears and should
be amenable for passing over static machine parts and also allow materials to
be gripped firmly or to be stacked.
Polyester/suitable paper backed packaging is also used for oral films. This type
of packaging is yet not applied in India partly due to the machinery involved and
its costing.
Cassette packing is mainly used to carry multiple dosages of breath freshener/
herbal/dietary supplements in a set of oral films

Testing Equipment for Evaluation of Critical Oral Film Properties
Moisture/Water content – Requirements concerning residual moisture content in oral films are not
described in the pharmacopoeia.
Karl Fischer Titration System: Testing equipment available in India or in general are designed to test
the water content in oral tablets/capsules and they need to be slightly modified/customized to test
the oral films. Due to the sticky nature of the oral films, the sample introduction point and the
electrode placement needs to be altered for effective testing of water content. This should not be a
difficult task if the KF equipment manufacturers are oriented on this aspect.
In-vitro Disintegration – Standard USP in-vitro disintegration tester apparatus with or without
modification for the sample container is being used.
The end-point determination of the disintegration process is variable leading to inconsistencies in
disintegration time. There are no pharmacopoeia limits set for disintegration time for oral films
(Existing guidelines for orally disintegrating/dissolving tablets as per various pharmacopoeia
monographs vary between 5 and 180 seconds).
19 of 31Suitable methods for effective testing of disintegration and water content in oral films are to be standardized RS/Jan 2018

Testing Equipment for Evaluation of Critical Oral Film Properties
In-vitro Dissolution - USP apparatus I (Basket) is being generally used to test the in-vitro dissolution
of oral films. In-vitro dissolution test applied for oral tablets/capsules cannot be directly applied to
oral films due to the variations in dosage composition and challenges associated with end-point
determination.
The in-vitro dissolution testing should be based on appropriate dissolution method of choice, with
the focus on simulating the oral cavity with little saliva (water or bio-relevant media) and the
mechanical stress of tongue and palate on films upon introduction.
A guiding precedent is available for testing the oral films from US-FDA prescribed USP Apparatus-I
(Basket) for Fenatnyl citrate buccal film; USP Apparatus-V (Paddle over disc) for the Buprenorphine
HCl/Naloxone HCl sublingual film and Ondansetron oro dispersible film products.
Diffusion – Ex vivo: Oro-mucosal film product development is based on studies on Franz-type
diffusion apparatus using biological/synthetic membranes to establish their drug muco-absorption.
Synthetic membranes mimicking the human oral mucosa need to be developed similar to the ones
developed for trans-dermal patches.
20 of 31Suitable methods for effective testing of disintegration and dissolution in oral films are to be standardized RS/Jan 2018

ORAL FILMS – DEVELOPMENT & EVALUATION
21 of 31Oral film products in India stored under long term conditions for >4 years indicate good stability in this form RS/Jan 2018
Stability Testing of Oral Film Finished Product
Stability testing for oral films is conducted in the container closure system (laminate alumina
sachet) proposed for marketing.
Systematic evaluation of the stability information including results from the physical, chemical,
microbiological and the dissolution tests is done on the oral film product under the long term
storage conditions (30°C and 65% RH) in India which has been applicable to all future batches of
the oral film product manufactured and packaged under similar circumstances. In addition data
from the accelerated storage condition (40°C and 75% RH) for six months also is being used to
evaluate the effect of short-term excursions outside the label storage conditions (monitoring of API
degradation/impurity generation) and for shelf-life prediction. Microbial limits specified for the oral
film finished product are indicated below.

ORAL FILMS – DEVELOPMENT & REGULATORY APPROVALS
Comparative Biological Evaluation Studies
Bioavailability studies demonstrate the amount and rate of drug appearing in systemic
circulation and though it does not fully determine the clinical effectiveness, it can be used to
assess the bioequivalenc (B.E.) of different pharmaceutical preparations.
The B.E. study design for oral films in India includes a single dose, randomized, two treatment
and two-way cross over study with the volunteers receiving either of the test preparation of oral
film or the reference preparation of oral tablet on the study day at a fixed time.
CDSCO-India approves the conduct of B.E. Studies on oral film products in comparison with
reference tablet/oral film products.
B.E. studies for the oral film products mentioned in
In the adjacent table have been conducted successfully
in India. Several other oral film products are in the
process of completion after prior approval of the
B.E. study protocols from CDSCO-India.
22 of 31Acceptable B.E. study results with reference oral tablet lead to the approval of oral film products by CDSCO-India RS/Jan 2018
ODF Product – B.E. Study accomplished
Ondansetron (8mg)
Sildenafil (50mg)
Tadalafil (20mg)
Montelukast (10mg)
Methylcobalamin (1500mcg)
Vitamin D3 (2000IU)
Levocetirizine (5mg)
Amlodipine (10mg)

ORAL FILMS – DEVELOPMENT & COMPARATIVE B.E. STUDIES
Pharmacokinetics of Oral Films
23 of 31Based on B.E., new oral film products can be used interchangeably with the conventional oral tablet formulations Jan 2018
Bioequivalence of newly developed oral film product with the reference oral tablet is
assumed based on the comparative bioavailability demonstrated with
pharmacokinetic study parameters Cmax, AUC0–t, t½, and Tmax.
No further clinical studies are mandated in the case of established comparative
bioequivalence between an oral tablet formulation and ODF product.
An oral film product exhibiting different pharmacokinetic profile compared to the
marketed reference oral tablet product is categorized as ‘new dosage form’ and in
this case a new clinical study could be suggested/mandated.
All the approved oral film products in India revealed no significant difference in
pharmacokinetics compared with those of the film coated oral tablet formulations. No
serious adverse events were reported in these B.E. study results reported till now.

ORAL FILMS – DEVELOPMENT & REGULATORY PROCESS
Oral Films – Clinical Trials Status for Marketing Approval
24 of 31No new non-clinical/clinical data other than B.E. study data was required for the approval of oral film products RS/Jan 2018
Globally, oral films have been approved for marketing based primarily/alone on
bioequivalence studies conducted with film coated oral tablets as a reference product.
As the pharmaco-dynamic, pharmaco-kinetic and toxicological properties of these drug
products are well-known, no new non-clinical data was submitted.
In all the oral film marketing approvals received till now in India, except the
bioequivalence study results, no other new non-clinical or clinical data were submitted,
which was acceptable as these oral film applications were based on sufficiently
demonstrated safety and efficacy of the drug substances.
Potential Environmental Risks Assessment
As most of the newly developed oral film products are based on the generic/hybrid
versions of already authorized drug molecule/product, it is justified that the
environmental exposure will not increase following approval of the marketing
authorization for the newly developed oral film product.

ORAL FILMS – PHARMACOVIGILANCE
25 of 31Regular PSUR submissions indicate that the risk-benefit profile of the drug remains favorable in oral film s RS/Jan 2018
Post Marketing Surveillance on Oral Films
Periodical Safety Update Report (PSUR) for the oral film products approved/being marketed
in India are submitted for the purpose of pharmaco-vigilance to the Drug Authority in India.
The PSURs available with the DCGI till now indicate that no cases were reported concerning
use of oral film products during the reporting interval periods. There have been no reports of
any increase in the frequency, severity or change in the outcome of the listed reactions during
the reporting interval periods.
There have been no safety related changes required or imposed from any regulatory agency
during the reporting interval period.
These approved products have not been refused registration in any other countries where
applied with regard to safety/efficacy post marketing.
No urgent safety restrictions or label amendments were proposed till now to the information
contained in the PSURs. The risk-benefit profile of the drug remains favorable.

ORAL FILMS – REGULATORY APPROVALS - INDIA
Oro-Dispersible Film products (mainly orally disintegrating strips/films)
Approved by the Central Drugs Standard Control Organization- CDSCO-INDIA
Prescription Drug Strength Indication Date of
Approval
Dextromethorphan 5.5mg, 11mg For the relief of persistent dry irritating cough in adult
patients only
28-01-2008
Simethicone 62.5mg For the treatment of flatulence and as adjuvant in
hyperacidity
14-11-2010
Ondansetron
hydrochloride
2mg, 4mg, 8mg For chemotherapeutic induced nausea and vomiting 29-3-2012
Sildenafil citrate 25mg, 50mg For the treatment of erectile dysfunction 5-07-2013
Tadalafil 10mg, 20mg For erectile dysfunction 30-07-2014
Methylcobalamin 1500mcg for the treatment of peripheral neuropathy and diabetic
neuropathy
17-12-2014
Levocetirizine
dihydrochloride
2.5mg,5mg For allergic rhinitis and chronic urticaria 14-1-2015
Ketorolac 10mg For the treatment of short-term management of
postoperative pain and musco-skeletal pain
29-4-2015
Montelukast
sodium
4mg, 5mg, 10mg For the relief of perennial allergic rhinitis in adults & pediatric
patients 6 months of age and older
29-5-2015
Cholecalciferol 2000 IU For the treatment of Vitamin D3 deficiency 1-10-2015
Amlodipine 2.5mg, 5mg, 10mg For the treatment of essential hypertension 7-01-2016
26 of 31Several oro-dispersible film products mainly the orally disintegrating forms have been approved in India RS/Jan 2018

ORAL FILM PRODUCTS – UNDER DEVELOPMENT IN INDIA
ODF – Orally Disintegrating/Dissolving Films
Drug Strength Treatment
Olanzapine 2.5/5/7.5//10/15/20mg Psychosis
Haloperidol 0.5/1/5//10mg Psychosis
Loratadine 10mg Histamine
Acetaminophen 10mg Pains
Caffeine 25/50mg CNS & ADHD
Armadafinil 50mg CNS Stimulant
Eszopiclone 1/2/3mg Hypnosis
Colchicine 0.5/1mg Gout
Drotaverine 40mg Spasms
Vardenafil 2.5/5/10/20mg Erectile Dysfunction
Risperidone 1/2/3/4mg Schizophrenia
Levocetirizine 10mg Histamine
Donepezil 5/10mg Neuro degeneration
Cetirizine 10mg Histamine
Lornoxicam 4/8mg Inflammation
Loperamide 2/5mg Diarrhea
Zolmitriptan 2.5/5mg Migraine
Piroxicam 20mg Inflammation
Rizatriptan 5/10mg Migraine/ Vertigo
Fingolimod 0.5mg Multiple Sclerosis
Naratriptan 2.5mg Migraine
Zolpidem 5/10mg Insomnia
Voglibose 0.2/0.3mg Diabetes
Prucalopride 1/2mg Constipation
Betahistine 8/16/24mg Tinnitus
(Test licenses approved by the CDSCO - India)
OMF - Sublingual Films
Drug Strength Treatment
Salbutamol 4/2mg Asthma
Ketorolac 10mg Inflammation
Terbutaline 2.5/5mg Asthma
Buprenorphine 2+0.5mg; 4+1mg;
+ Naloxone 8+2mg; 12+3mg Opioid addiction
Fentanyl 200/400/600/800/1200mcg Pains
Teriparatide 20/250/600/750mcg Arthritis/Osteoporosis
27 of 31Several drug moieties for various indications are on the way for R&D in the form of Oral films in India RS/Jan 2018

Examples of ODS Products being developed/ reviewed or approved in INDIA
(By FSSAI; Food Safety and Standards Authority of India)
ODF – HEALTH SUPPLEMENTS & HERBALS
ODF – Orally Disintegrating/Dissolving Films
Nutraceutical/Herbal Strength __Function
Melatonin 0.5/1/3/5mg Sedative & Hypnotic
Folic acid 0.5mg Vitamin
Nicotine 2/4mg Cholinergic
Niacin 75mg Vitamin
Folic acid + Pyridoxine + Vitamin C 0.5mg + 1mg + 25mg Vitamins
Vitamin D3 200 IU Vitamin
Vitamin D3 + Methylcobalamin + Folic Acid 2000 IU + 1500mcg + 0.5mg Vitamins
Bacopa Monnieri 100mg Antioxidant
Withania Somnifera 100mg Adaptogen
Menthol + Essential oils Mouth freshener
Vitamins & Minerals Electrolyte
Methylcobalamin 60000 IU Vitamin
28 of 31A plethora of nutraceutical/food supplement ingredients are in store for development in to effective oral films RS/ Jan 2018

ADDITIONAL ORAL FILM DRUG PRODUCTS APPROVED ABROAD
29 of 31Several other oral films (including sublingual forms) approved abroad can be investigated for use in India. RS/Jan 2018
Eucalyptol, Menthol, Methylsalicylic acid & Thymol oral film
(OTC – Listerine pocket packs); antibacterial
Suboxone sublingual film 8mg/2mg; 2mg/0.5mg; anti-opioid addiction
(Buprenorphine/Naloxone)
Donepezil orodispersible film 3/5/10mg; anti-dementia
Rizatriptan oral thin film 10mg; anti-migraine
Zolmitriptan orodispersible film 2.5mg; anti-migraine
Olanzapine orodispersible film 5/10/15/20mg; antipsychotic

OTHER ORAL FILM (Nutraceutical/Food Supplement) PRODUCTS APPROVED ABROAD
30 of 31Several oral film products are marketed as nutraceutical/herbal/food supplement products worldwide RS/ Jan 2018
Product Category Ingredients
Energy booster/Detoxification Caffeine, green tea extract & guarana
Male vitality Maca root extract, ginseng extract
Appetite suppressant Fucus vesiculous and guarana extract,
Garcinia cambogia
Listerine equivalent/ Antibacterial Mint & cetylpyridinium chloride
Multivitamins for kids & adults B6, B12, C, D3…
Food Supplements/Nutraceuticals Benzocaine, Caffeine, Melatonin,
Menthol, Hoodia, Vincopectine etc.
Minerals Chromium
Anti-ageing support Resveratrol, quercetin & green tea
extract
Following is a partial list of oral films marketed as nutraceutical/food supplement products abroad

ORAL FILMS – PATENT APPLICATIONS & STATUS - INDIA
S. No. Application No. Title Date of Filing Status
1. 1974/CHE/2008 PERFORATED WATER SOLUBLE POLYMER BASED EDIBLE FILMS August 14, 2008 Granted
(Inventor/Applicant:Venkatesh Katakam)
1. 954/CHE/2012 TASTE MASKING PHARMACEUTICAL ORALLY DISSOLVING STRIPS OF LORNOXICAM March 15, 2012 Published
(Co-Inventors: Venkatesh Katakam & K. Adinarayana Reddy)
3. 955/CHE/2012 TASTE MASKED ORALLY DISSOLVING STRIPS OF SILDENAFIL CITRATE March 15, 2012 Published
4. 956/CHE/2012 RAPID ORALLY DISSOLVING STRIPS OF TADALAFIL March 15, 2012 Published
5. 4608/CHE/2012 TASTE MASKED AMLODIPINE STRIP FORMULATION Nov 5, 2012 Published
(Co-Inventors:Venkatesh Katakam & Adinarayana Reddy Kadapa)
6. 4613/CHE/2012 MONTELUKAST STRIP DOSAGE FORM Nov 5, 2012 Published
(Co-Inventors:Venkatesh Katakam & Adinarayana Reddy Kadapa)
7. PCT/IB2014/065871 PHARMACEUTICAL FILM COMPOSITION Nov 7, 2014 Published
(Co-Inventors:NavneetMundada, Ritesh Vinod Birla, Badrinath Allampalli & Akshay Kant Chaturvedi)
8. PCT/IB2016/051557 SUBLINGUAL FILM OF KETOROLAC March 19, 2016 Published
(Co-inventors:Sridhar Rudravarapu,Ritesh Vinod Birla & Manohar Katakam
9. 1500/CHE/2015 SUBLINGUAL FILM OF SALBUTAMOL March 24, 2015 Unpublished
(Co-inventors:Sridhar Rudravarapu,Ritesh Vinod Birla & Manohar Katakam)
10. 1501/CHE/2015 PHARMACEUTICALSUBLINGUAL FILM OF TERBUTALINE March 24, 2015 Unpublished
(Co-inventors:Sridhar Rudravarapu,Ritesh Vinod Birla & Manohar Katakam)
11. PCT/IB2016/054102 ORALLY ADMINISTRABLE FILM DOSAGE FORM CONTAINING FINGOLIMOD July 8, 2016 Published
(Co-inventors:Venkatanarayana Kurella, Sridhar Rudravarapu & Akshay Kant Chaturvedi)
END SLIDESeveral Patent Applications on oral films (more than 11) have been filed by Indian companies till date RS/ Jan 2018
List of patent applications on oral film products filed on behalf of M/s NU Therapeutics Pvt. Ltd.
& Shilpa Medicare Ltd. in India (List may be in-complete with contributions from other sources)

Oral Films Development & Manufacturing in India - Current Scenario

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