anti-inflammatory TDDS

1. Presentation
on
Formulation and Evaluation of Novel Anti-
inflammatory Transdermal Drug Delivery System
presented by
Sunita Thakur
(Enrollment no: 1512202007)
Prof. P.K Sharma Dr. Md. Aftab Alam
Dean, Asst. Prof.
School of Medical and Allied Sciences, School of Medical& Allied Sciences,
Galgotias University, Greater Noida Galgotias University, Greater Noida
(Guide) (Co-Guide)
Department of Pharmacy
School of Medical and Allied Sciences
GALGOTIAS UNIVERSITY
Yamuna Expressway, G.B Nagar (U.P)

2. TABLE OF CONTENTS
S. NO. TITLE
1. INTRODUCTION
2. LITERATURE REVIEW
3. AIM AND OBJECTIVE
4. RATIONALE OF THE STUDY
5. PLAN OF WORK : RESEARCH ENVISAGED
6. EXPECTED OUTCOMES
7. CONCLUSION
8. REFERENCES

3.  Transdermal therapeutic delivery may be defined as a
self contained, discrete dosage forms which, when
applied to the intact skin, deliver the drug, via the skin
at control rate for the systemic effect. (Gannu, R. et
al., 2007)
 Examples-
1. Transderm-Nitro Nitroglycerin once a day medication
for angina (Novartis).
2. Transderm-Scop Scopolamine for 72 hrs in treatment of
motion sickness (Novartis).
3. Trans-Ver-Sal Salicylic acid for topical keratolytic action
(Doak)
4. Antihypertensive, antiangina, antihistamine, anti-
inflammatory, analgesic and steroids. (Kumar P, et
al.,2004).

4.  Backing Layer
 Drug
 Membrane
 Adhesive
 Liner

5. M
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1.Membrane type-( Sonam M. Ghandhi, 2013)

6. A
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P
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FORMULATION APPROCHES-

7. M
A
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Y
P
E
FORMULATION APPROCHES-

8. M
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O
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9. The following routes are observed in
transportation of penetrant through
skin barrier:
(1) Across the intact horny layer,
(2)Through the hair follicles with the
associated sebaceous glands, or
(3) Via the sweat glands
Routes of Penetration

11. The ideal enhancer should have the following conditions:(Bary
B.W, et al., 1983)
1. Non-pharmacological activities.
2. Nontoxic, non-allergenic, and non-irritating.
3. Rapid-acting with predictable and reproducible activity.
4. When removed from the skin surface, the penetrability of the
skin should recover immediately.
5. Cosmetically acceptable with suitable skin .
e.g.These include water, pyrolidones, fatty acids and alcohols,
azone and its derivatives, alcohols and glycols, essential oils,
terpenes and derivatives, sulfoxides like dimethyl sulfoximide
and their derivatives, urea and surfactants.

12.  Avoids first pass metabolism
 Avoids gut associated
metabolism
 Avoids pain associated with
injection
 Continuous “ sustained release”
drug delivery with infrequent
dosing
 Potential zero-order drug
delivery
 Easy to terminate therapy
Drug that require high blood
levels cannot be administered
Adhesive may not adhere well to
all types of skin
Drug or drug formulation may
cause skin irritation or sensitization
Uncomfortable to wear
May not be economical
Only relatively potent drugs.
Only small and lipophillic drugs
are administered.
ADVANTAGES DISADVANTAGES

13.  Small daily dose < 10 mg- potent . Examples include
testosterone, scopolamine, nitroglycerin, fentanyl, clonidine
and 17 ß Estradiol
 Molecular weight should be < 500 Da
 High Partition coefficient
 Water soluble at physiological pH
 Non-irritating, non-sensitizing, non-allergenic
 Good stability

14. a) Adequate skin permeability:
 Drugs with low molecular weight
 Drugs with low melting point
 Drugs with moderate oil and water solubility
b) Adequate skin acceptability:
 Non-irritating drugs.
 Non-toxic drugs.
Non-metabolizing drugs.
c) Adequate clinical need:
 Need to prolong administration
 Need to reduce side effects on target tissues
 Need to increase patient compliance.

15. criteria should be satisfied for a polymer to be used in TDDS :
a) Molecular weight, chemical functionality of the polymer should be such
that the specific drug diffuses properly and gets released through it.
b) The polymer should be stable.
c) The polymer should be nontoxic
d) The polymer should be easily of manufactured
e) The polymer should be inexpensive
f) The polymer and its deagration product must be non toxic or non-
antagonistic to the host.
g) Large amounts of the active agent are incorporated into it.

16. Product name Drug Manufacturer Uses
Alora Estradiol Theratech Hormone
Replacement
Androderm Testosterone GlaxoSmithKline Hypogonadism
Catapres TTS Clonidine Alza/ Boehinnger Hypertension
Combipatch Estradiol Noven Hormone
Replacement
Deponit Nitroglycerin Schwarz Pharma Angina Pectoris
Duragesic Fentanyl Jansen
Pharmaceutical
Severe Pain
Estroderm Estradiol Novartis Post-menstrual
Syndrome.

17. S.no
.
Author’s Name Year Workdone
1. Chinchole P. et al., 2016 States that TDDS facilitate the delivery of
API of drug through skin & can improve
therapeutic efficacy and safety ,also
describes various types of TDDS patches .
2. Bathe R. et al., 2015 Gives detail information regarding
diffusion process through which drug
diffuses into blood , having high conc.. On
patch & low conc.. In blood, drug will keep
diffusing for long period of time
maintaining constant drug conc.. In blood
flow.

18. 3. Reddy V. et al., 2014 Describes briefly about the modes of drug
administration , advantages, and
disadvantages of TDDS, drug penetration
pathway, type of TDDS etc & considers
TDDS as novel approach of delivery drug
across skin.
4. Ghulaxe C. et al., 2015 Investigated with aimed to formulate
transdermal film incorporated with herbal
drug components and observed that well
known ayurvedic drugs have been formed to
be effective through modern pharmaceutical
formulation techniques.

19. 5. Sachan R. et al., 2013 Emphasized on the three generations of
TDDS which start a new era of delivery of
drug & proven that delivery through this
technology offers significant clinical
benefits over other dosage form.
6 Rastogi V. et al., 2012 Gives detailed information about main
routes of drug penetration which includes
the appendages, transcellular, &
intercellular, permeation via rate limiting
barrier stratum corneum.
LITERATURE REVIEW-

20. 7. Anisree G. et al., 2012 Worked on Metoprolol tartrate,
modifying it from conventional to
TDDS successfully rectify its drawback
i.e.. Due to short half life it gets
metabolized via first pass metabolism.
8. Uzor P. et al., 2011 Presents a comprehensive account of
various aspects of drug delivery by
transdermal routes including the various
chemical & physical penetration
enhancers.
LITERATURE REVIEW-

21. AIM:
 Formulation and evaluation of Anti-inflammatory transdermal Patches.
OBJECTIVE:
 To prepare transdermal patches.
 To evaluate transdermal patches.
 To perform in-vitro dissolution testing of prepared patches.
 To perform stability studies of prepared patches.
AIM AND OBJECTIVE

22.  Selection of Drug/Excipient
 Preformulation Studies
 IR Spectroscopy
 Melting point studies
 Calibration curve
 Solubility studies
 Formulation of transdermal drug delivery system
 Evaluation of transdermal drug delivery system
 Thickness of Patch
 Weight Uniformity
 Folding Endurance
 Percentage moisture uptake
 Percentage moisture content
 Water vapour permeability (WVP) evaluation
 Uniformity of dosage unit test
 Stability studies
 Compilation of Data.
 Thesis writing.
RESEARCH ENVISAGED: PLAN OF WORK

23.  The Rational approach is using skin delivery for systemic
treatment.
eg. Transdermal therapeutic systems provide systemic therapy for
conditions such as motion sickness, angina pectoris.
 By Providing smoother, continous drug delivery and steadies
plasma levels .
 It may reduces the incidence of side-effects.
 Making optimal therapeutic doses easier to attain & Potentially
improving treatment efficacy & compliance.
 TDDS patches are more patient and caregier friendly may enable
patients to continue treatment for longer periods.
 To attain greater, more sustained treatment benefits.
 Delivering of drugs directly to the viable skin , tissues without using
Rationale of TDDS-

24. •Prepared controlled release transdermal patch may be used for
providing the constant systemic effect.
•It will be able to deliver the drug in controlled manner for
prolong time.
•This will reduce the dosing frequency and so it will provide
better patient compliance.

25.  Transdermal drug delivery system is a kind of
delivering system which delivers the medicine to the
general circulation through the skin is seen as a
desirable alternative to the oral.
 Intact skin is not sufficiently Permeable to the
majority of drugs, hence permeation enhancement is
needed.
 TDDS improves the efficacy , safety and
convenience of use.

26.  Gannu ,R.,Vamshi Y.V,Krishan V.,Rao,Y.M, Development of
Niterndipine transdermal patches :in-vitro &Ex-vivo
characterization ,current drug delivery,2007;4,pg.no-69-76.
 Kumar P, Shankar C, Mishra B.; Delivery of macromolecules
through skin, The Indian Pharmacist 2004, 5(3); pg.no:7-17.
 Pravin Chinchole, Sagar Savale & Kambh Waelile, A novel
approach on transdermal drug delivery system, World Journal of
Pharmacy and Pharmaceutical Sciences, 2016; vol-5, issue 4.

27.  Ritesh Bathe & Reni Kapoor, Transdermal drug delivery
system :Formulation , development & evaluation –An
overview, International Journal of Biomedical & Advance
TDDS-33 research,2015; vol-6 (01), pg.no:1-10.
 B. Venkateswara Reddy, S. Satyanandam , Transdermal drug
delivery system – A review, International Journal of
Chemistry & Pharmaceutical Sciences , 2014;vol-2(15).
 Chetan Ghulaxe ,Rameshwar Verma , A Review on
Transdermal Drug Delivery System , The Pharma Innovation
Journal, 2015; VOL-4 (1), Pg.no:37-43.

28.  Richa Sachan, Meenaskhi Bajpai, Transdermal drug delivery
system :A Review , International Journal of Research and
Development in Pharmacy & Lifesciences, 2013; vol-3(4),
pg.no:748-765.
 Vaibhav Rastogi, Pragya yadav, Transdermal drug delivery
system: A overview, Asian Journal of Pharmaceutics, 2002.;
6(3)Pg.no:161.
 Anisree G.S, Ramasamy C, John Wesely, Formulation of
Transdermal drug delivery system of Metoprolol Tartrate and its
evaluation , Journal of Pharmaceutical sciences &
research,2012;vol-4(10).

29.  P.F. Uzor, E.O. Omeje, C. J. Mbab, Prospective On Transdermal
Drug Delivery , Journal Of Chemical & Pharmaceutical
Research, 2011; Vol-3(3).
 Bary B.W, Dermatological formulation: Percutaneous
absorption, Marcel Dekker, 1983;Pg.no:238.