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Transdermal drug delivery system
1. R
ANSDER
MAL DR
UG DELIVER SYST
Y
SSJ COLLEGE OF P
HAR
MACY
(Appr oved by AI CTE & PCI & Af f iliat ed t o J NTU
Univer sit y, Hyder abad)
Vat t inagulaPally, Gandipet , Hyder abad – 500 075.
GUI DANCE: S.RAMYA LATHA
PRESENTI ED BY,
B.RUTHU
10FJ 1R0001
1
2.
INTR
ODUCTION
ADVANTAGES AND LIMITATIONS
SK
IN AND EP
IDER
MIS STR
UCTUR
E
COMP
ONENTS OF TR
ANSDER
MAL P
ATCH
TYP OF TR
ES
ANSDER
MAL P
ATCH
FACTOR AFFECTING TR
S
ANSDER
MAL P MEAB
ER
ILITY
P
OLYMER
S
THER IES THAT USE TR
AP
ANSDER
MAL DELIVER OF DR
Y
UGS
CLASSIFICATION OF TDDS
B
ASIC COMP
ONENTS OF TDDS
EVALUATION
CONCLUSION
R
EFER
ENCE
2
3.
Tr ansder mal deliver y r epr esent s an at t r act ive
alt er nat ive t o or al deliver y of dr ugs and is poised
t o pr ovide an alt er nat ive t o hypoder mic inj ect ion
t oo.
For t housands of year s, people have placed
subst ances on t he skin f or t her apeut ic ef f ect s.
Def init ion:
Tr ansder mal dr ug deliver y syst ems (pat ches) ar e
dosage f or ms designed t o deliver a
t her apeut ically ef f ect ive amount of dr ug acr oss a
pat ient ’s skin also def ined as Medicat ed adhesive
3
4.
Reduces f ir st -pass met abolism ef f ect and
GI incompat ibilit y
Sust ains t her apeut ic dr ug levels
Per mit s self -administ r at ion
Non-invasive (no needles or inj ect ions)
I mpr oves pat ient compliance
Reduces side ef f ect s
Allows r emoval of dr ug sour ce
Long act ing dr ug deliver y
4
5.
Poor dif f usion of lar ge molecules
Skin ir r it at ion
Only suit able f or ver y pot ent dr ugs
Mor e expensive t han or al dr ugs
5
7. 1. Liner - Pr ot ect s t he pat ch dur ing st or age.
2. Drug - Dr ug solut ion in dir ect cont act wit h
r elease liner .
3. Adhesive - Ser ves t o adher e t he component s
of t he pat ch t oget her along wit h adher ing t he
pat ch t o t he skin.
4. Membrane - Cont r ols t he r elease of t he dr ug.
5. B
acking - Pr ot ect s t he pat ch.
7
8. ) Single- layer Drug- in- Adhesive: The
adhesive layer of t his syst em also cont ains
t he dr ug.
(2) multi- layer drug in adhesive: One of t he
layer s is f or immediatis a elease of t hement
The dr ug layer e r liquid compar t dr ug
and ot her layer is f or cont r ol r elease of dr ug
cont aining a dr ug solut ion or suspension
f r om t he r eser vior . t he adhesive layer
separ at ed by
(3) R
eservoir:
(1
(4) Matrix: The Mat r ix syst em has a dr ug
layer of a semisolid mat r ix cont aining a dr ug
solut ion or suspension.
8
9. (A) Physicochemical pr oper t ies of t he
penet r ant s:
1. Par t it ion coef f icient .
2. PH condit ions.
3 . Penet r ant concent r at ion.
(B) Physicochemical pr oper t ies of dr ug deliver y
syst ems:
1. Release char act er ist ics.
2. Composit ion of dr ug deliver y syst ems3. Enhancement of t r ansder mal penet r at ion.
(C) Physiological and pat hological condit ions of
t he skin
9
10. P
olymer s ar e t he backbone of a t r ansder mal dr ug
deliver y syst em. Syst ems f or t r ansder mal
deliver y ar e f abr icat ed as mult i-layer ed polymer ic
laminat es in which a dr ug r eser voir or a dr ug
polymer mat r ix is sandwiched bet ween t wo
polymer layer s an out er imper vious backing layer
t hat pr event s t he loss of dr ug t hr ough t he
backing sur f ace.
Examples :HPMC 100, CMC, Polyet hylene glycol,
polycar bonat e, PVA, Polycar bonat e, Sodium
alginat e
10
11. Therapy
Drug Delivered by
TDDS
Mot ion Sickness
Scopolamine
Ant i-angina
Nit r oglycer ine
Hypertension
Clonidine
Smoking Cessat ion
Nicot ine
Hor mone Replacement Est r adiol
Ther apy
Est r adiol/ Pr ogest in
Test ost er one
Pain Management
Fent anyl
Lidocaine
11
12. 1. P
olymer membrane permeationcontrolled.
2. P
olymer matrix dif f usioncontrolled
3. Drug reservoir gradient- controlled
4. Micro reservoir dissolutioncontrolled
12
13. (1)
(2)
(3)
(4)
(5)
(6)
Solut ion in mat r ix
Suspension in cont inuous mat r ix
Suspension in por ous mat r ix
Solut ion upst r eam of membr ane
Suspension upst r eam of membr ane
Laminat ed membr ane downst r eam
13
14. 1) I ont ophor esis:
I t is an elect r ochemical met hod
t hat enhances t he t r anspor t of some
solut e molecules by cr eat ing a
pot ent ial gr adient t hr ough t he skin
wit h an applied elect r ical cur r ent or
volt age.
2)Elect r opor at ion:
I t is a met hod wher e high volt age
elect r ical pulses supplied t o t he skin.
14
15. Non-invasive, needle-f r ee
Rapid onset and cessat ion kinet ics
Cont r olled, pr ogr ammable and
t it r at able dr ug deliver y capabilit ies
Abilit y t o pr ovide smoot h, var iable
or bolus plasma levels, singly or in
combinat ion, all in a single deliver y
syst em
Enhanced t r ansder mal deliver y f or a
br oad r ange of compounds, including
lar ge dr ug molecules such as
pept ides and oligonucleot ides
Minimal var iabilit y in t he deliver y
15
16. SCIENTIFIC B
ASIS OF
IONTOP
HOR
ESIS
The Ner nst -Planck equat ion, seen below, is t he
t r adit ional r elat ionship accept ed f or descr ibing
t r anspor t of an ionic species acr oss a membr ane:
J = DzVFC/ kT+ Cu - D(dC/ dx)
wher e J = molar f lux
D = dif f usivit y coef f icient
C = t he concent r at ion (molar )
u = t he convect ive f low of wat er
T = t emper at ur e
k = Bolt zman' s const ant
z = char ge on t he species
16
17. Phonophor esis is t he int r oduct ion of subst ances int o t he
body by ult r asonic ener gy. Unlike iont ophor esis which
involves t he t r ansf er of ions int o t he t issue,
phonophor esis t r ansmit s molecules a dif f er ent pr ocess
alt hough similar in concept .
Some of t he common chemicals compounded f or
phonophor esis include:
•Bet amet hasone Dipr opionat e
•Dexamet hasone
•Dexamet hasone / Lidocaine
•Fluocinonide
•Hydr ocor t isone
•Hydr ocor t isone / Lidocaine
17
20. Matrix
Simplif ied pat ch
const r uct ion
Complex f or mulat ion
Skin cont r olled
deliver y
Thinner const r uct ion
Excellent skin
conf or mabilit y
Ef f icient ut ilizat ion
of size
Low dose dumping
R
eservoir
Complicat ed pat ch
const r uct ion
Simplif ied f or mulat ion
Membr ane moder at ed
deliver y
Mult iple layer s
Poor skin conf or mabilit y
Requir es ext ended size
Dose dumping pot ent ial
20
21.
The pat ches wer e pr epar ed by solvent cast ing
met hod .
The polymer (Car bopol/ HPMC) was t aken in a beaker
wit h aminimum quant it y of t he solvent Then 2/ 3r d
of t he solvent was mixed wit h t he ot her polymer s
(Eudr agit L 100) and was added wit h st ir r ing at
lower r pm init ially and lat er at a higher speed.
The plast icizer was added and unif or mly mixed and
t he dr ug was incor por at ed wit h cont inuing agit at ion
and t he volume was made up.
The f ilms wer e cast ont o a suit ably designed and
f abr icat ed glass mould and t hen dr ied in oven at
40oC.
The f ilms wer e r emoved by using shar p blade by
inser t ing along t he edges of t he f ilm.
21
22.
Clinical evaluat ion
For mulat ion and manuf act ur ing scale-up
St abilit y st udies
Analyt ical evaluat ion
Regulat or y submission and appr oval
22
23. 1.Weight unif or mit y.
2.Thickness.
3.Folding endur ance.
4.% moist ur e cont ent .
5.Moist ur e upt ake.
6.% Elongat ion br eak t est .
7.Dr ug cont ent .
8.I n-vit r o dr ug r elease st udies.
9.Skin ir r it at ion st udies.
23
24.
Due t o t he r ecent advances in t echnology and
t he incor por at ion of t he dr ug t o t he sit e of
act ion wit hout r upt ur ing t he skin membr ane
t r ansder mal r out e is becoming t he most
widely accept ed r out e of dr ug administ r at ion.
I t pr omises t o eliminat e needles f or
administ r at ion of a wide var iet y of dr ugs in
t he f ut ur e.
To opt imize t his dr ug deliver y syst em,
gr eat er under st anding of dif f er ent
mechanism of biological int er act ions, and
polymer s ar e r equir ed.
24
25. 1..Williams A. London: Phar maceut ical Pr ess; 2003.
Tr ansder mal and Topical Dr ug Deliver y.
2. Pr ausnit z MR, Mit r agot r i S, Langer R. Cur r ent
st at us and f ut ur e pot ent ial of t r ansder mal dr ug
deliver y.t Rev Dr ug Discov. 2004;3:115–124.
3. Br onaugh RL, Maibach HI , edit or s. Edn. 4t h.
New Yor k: Mar cel Dekker ; 2005. Per cut aneous
Absor pt ion.
4. Miller MA, Pisani E. The cost of unsaf e
inj ect ions. Bull Wor ld Healt h Or gan.
1999;77:808–811.
5. Ault on.M.E, Phar maceut ics; The science of
dosage f or m design, second edit ion, Chur chill
Livingst on, Har cour t publisher s-2002.
6. Ansel.H.C, Loyd.A.V, Popovich.N.G,
Phar maceut ical dosage f or ms and dr ug deliver y
25
This presentation provides an introduction to transdermal drug delivery.
Transdermal drug delivery (TDD) uses diffusion of the medication through the skin into the systemic circulation where it is distributed for therapeutic effect. Currently, most TDD systems use passive delivery.
Transdermal delivery offers a variety of advantages over oral delivery and injections. Because TDD enables the drug to bypass the digestive system, metabolism of the drug by the liver is avoided and more of the drug can enter the bloodstream. This is called avoiding the “first-pass effect.” There is also less chance of gastrointestinal side effects. Transdermal delivery can provide sustained therapeutic drug levels, currently up to seven days. TDD systems can be self-administered and are non-invasive, so they help improve patient compliance. Transdermal delivery can reduce the incidence of side effects because it reduces peak levels of drug in the plasma. TDD also permits removal of the drug source, if necessary.
TDD also has limitations. Currently, using TDD for diffusion of large molecules provides poor results. Some patients also may experience skin irritation in response to using TDD systems.
The greatest challenge for transdermal systems is penetrating the skin.
Transdermal systems are currently used to provide therapy for a variety of conditions including motion sickness, anti-angina, hypertension, smoking cessation, hormone replacement therapy and pain management.
For a standard transdermal patch of a given surface area, the critical predictor of delivery is the permeability coefficient.
There are four typical constructions used in transdermal patches. In the matrix design, which is probably the simplest approach, the drug formulation is contained in a non-adhesive reservoir that is held in contact with the skin by an adhesive overlay. In the reservoir design, the drug formulation is held in an envelope formed between the backing and the membrane. In the single-layer drug-in-adhesive design, the drug formulation is incorporated within the skin-contacting adhesive. The multi-layer drug-in-adhesive configuration is similar to the single-layer design. However, it incorporates either a membrane between two distinctive drug-in-adhesive layers or the addition of multiple drug-in-adhesive layers under a single backing film.
This table compares the features of drug-in-adhesive and reservoir configurations. While a reservoir system has a complicated construction, its drug formulation is usually simpler. In contrast, a drug-in-adhesive patch has a simpler construction but requires a complicated formulation to successfully incorporate the drug and excipients and provide adhesion to the skin. Drug delivery from a reservoir patch is moderated by a membrane but in a drug-in-adhesive patch is controlled by the skin. The multiple layers of a reservoir patch can lead to poor skin conformability. However, a drug-in-adhesive patch has thinner construction enabling excellent skin conformability. While a reservoir patch needs an extended size, a drug-in-adhesive patch offers efficient size utilization. Finally, the use of a rate moderating membrane in the reservoir construction creates the potential for dose dumping. If the membrane layer becomes compromised, the direct exposure of the liquid reservoir to the skin may result in a dramatic increase in the rate of drug delivery to the patient. Because the drug-in-adhesive configuration does not have a membrane layer, the potential for dose dumping is very low.
Once a new prototype transdermal patch has been developed, it must proceed through additional development stages. The stages include clinical evaluation, formulation and manufacturing scale-up, stability studies, analytical evaluation, and regulatory submission and approval.
