Novel drug delivery systems aim to optimize drug delivery to achieve the desired therapeutic effects. They can provide precise dosing, improve drug efficacy through more efficient absorption, and enhance patient comfort. Rapidly dissolving tablets are one type of novel delivery system that can dissolve quickly in the mouth for rapid drug release. They are commonly prepared through direct compression of the drug with superdisintegrants or by freeze drying drug solutions in blister packs. Excipients like croscarmellose sodium, crospovidone, and sodium starch glycolate are often used as superdisintegrants in these systems to promote rapid tablet disintegration. Lollipops have also been used to deliver drugs through the oral mucosa for rapid absorption, such as

1. Sandeep
Mewada
NOVEL DRUG
DELIVERY SYSTEM

2. Novel Drug delivery System
(NDDS) refers to the approaches,
formulations, technologies, and
systems for transporting a
pharmaceutical compound in the
body as needed to safely achieve its
desired therapeutic effects.
NOVEL DRUG DELIVERY SYSTEM

3. 1.Optimum dose at the right time
and right location.
2.Efficient use of expensive drugs,
excipients and reduction in
production cost.
3.Beneficial to patients, better
therapy, improved comfort and
standard of living.
•ADVANTAGES OF NOVEL DRUG
DELIVERY SYSTEM ARE:

4. Introduction
Despite tremendous innovations in drug
delivery, the oral route remains the
preferred route for administration of
therapeutic agents because of accurate
dosage, low cost therapy, self medication,
non invasive method, and ease of
administration leading to high level of
patient compliance.
ORAL ROUTE OF ADMINISTRATION

5. RAPIDLY DISSOLVING TABLETS (RDTS)

6. FORMULATION OF RDT’S

7. Molded tablets are prepared by forcing dampened
powders under low pressure into die cavities.
Solidification depends upon crystal bridges built
up during the subsequent drying process.
Molded tablets made from completely and readily
water-soluble ingredients.
They are employed orally, or where rapid drug
availability is required such as in the case of
Nitroglycerin Tablets, sublingually.
FORMULATION OF RDT’S

8. Molded tablets are prepared from mixtures of
medicinal substances and a diluent usually
consisting of lactose and powdered sucrose in
varying proportions.
The powders are dampened with solutions
containing high percentages of alcohol.
The dampened powders are pressed into molds,
removed, and allowed to dry.
Molded tablets are quite friable and care must be
taken in packaging and dispensing.
PREPARATION OF MOLDED TABLETS

9.  The drug is dissolved or dispersed in an aqueous solution of a
carrier.
 The mixture is poured into the wells of the preformed blister
packs.
 The trays holding the blister packs are passed through liquid
nitrogen freezing tunnel to freeze the drug solution.
 Then the frozen blister packs are placed in refrigerated
cabinets to continue the freeze drying.
 Finally the blisters are packaged and shipped.
 Characteristics: The preparations are highly porous, have high
specific surface area, dissolve rapidly and ultimately show
improved absorption and bioavailability.
LYOPHILIZATION

10. * The temperature and pressure should
be below the triple point of water i.e.,
0.0098°C and 4.58mmHg. Easily
removes moisture up to 98% to 99%.
** The temperature is raised to 50°C –
60°C and vacuum is lowered about
50mmHg. It takes about 10-20 hrs.
STEPS INVOLVED IN LYOPHILIZATION

11. SECONDARY DRYING STAGE**
FREEZING STAGE

12. Advantage
Water sensitive drug are
prepared by this
method as RDTs
instead of dry granulation
(delay DT)
LYOPHILIZATION

13. Disadvantage
Some portion of drug
remains in the wells of
the blister packs
LYOPHILIZATION

14. Loratidine (Claritin Reditab and
Dimetapp Quick Dissolve)
Cisapride monohydrate
(Propulsid Quicksolv)
Risperidone (Risperdal M-tab)
Ibuprofen (Nurofen Flashtab)
EXAMPLES

15.  A direct compression method uses conventional equipment,
commonly available excipients, and a limited number of process
steps.
 The direct compression tablet's disintegration and solubilization
are based on the single or combined action of super
disintegrants, water-soluble excipients, and effervescent agents.
 The choice of superdisintegrant for a tablet formulation depends
largely on the nature of the drug being used.
 TizanidineHCl,OxybutyninHCl,Rofecoxib,and Ethenzamide are
some examples of model drugs that have been formulated as RDT
by direct compression method.
 Super
 Disintegrants
 Used In Rapid Disintegrating Tablets
DIRECT COMPRESSION

16. Synonyms: (Ac-Di-Sol)
Cross linking makes it an insoluble, hydrophilic,
highly absorbent material, resulting in excellent
swelling properties and its unique fibrous nature
gives it excellent water wicking capabilities.
Croscarmellose sodium provides superior drug
dissolution and disintegration characteristics,
thus improving bioavailability of formulations
CROSCARMELLOSE SODIUM

17. Synonyms:- Crosslinked
polyvinylpyrrolidone (PVP), Insoluble
PVP, Polyvinylpolypyrrolidone
(PVPP), Crospovidone ,
Crospovidonum
Crospovidone, NF, is a synthetic,
insoluble but rapidly swellable, cross-
linked homopolymer of N-vinyl-2-
pyrrolidone
CROSPOVIDONE

18. Synonyms: Carboxymethyl starch,
Explotab, Primojel
Primojel promotes water penetration into
the tablet and develops a disintegration
force needed to push the particles apart.
High swelling capacity results in its high
disintegration rate and efficiency.
SODIUM STARCH GLYCOLATE

19. PHARMACEUTICAL LOLLIPOPS

20.  Lollipops have been used to deliver pharmaceuticals
(chiefly, Lipophilic drugs) to patients.
 Provide rapid absorption into the blood stream through
the mucosa of the mouth
 Absorption occurs much more rapidly than when drugs
are swallowed and absorbed via the digestive system.
 The dose can easily be controlled by administering the
lollipop only until the desired effect is observed,
thereby minimizing the dose
 Lollipops provide a pleasant way for a reluctant patient
to receive the pharmaceutical.
PHARMACEUTICAL LOLLIPOPS

21. In particular, lollipops containing
the potent,short-acting narcotic
fentanyl have been approved by the
FDA for the treatment of severe
pain.
• For example: Actiq by Cephalon
PHARMACEUTICAL
LOLLIPOPS

22.  It is a solid formulation of fentanyl citrate on a plastic
stick that dissolves slowly in the mouth for absorption
across the buccal mucosa.
 It is effective in treating cancer breakthrough pain
and other problems, such as bone injuries, migraines,
severe back pain, cluster headaches, neuropathy,
arthritis, and moderate to severe chronic, non-
malignant pain.
 The dosage unit is a white, berry-flavored lozenge on
a stick which is swabbed on the buccal mucosa,
between cheek and gum to release the fentanyl
quickly into the bloodstream.
FENTANYL LOLLIPOP

23.  Absorption
 Normally 25% of the drug is absorbed via the buccal
mucosa directly into the bloodstream while the
remaining
 75% is swallowed and then slowly absorbed in the
gastrointestinal tract.
 Two-thirds of the swallowed dose is metabolized by
the liver and becomes unavailable
 25% of the total dose will reach the bloodstream via
the intestines
 50% of the total dose will reach the bloodstream via
both routes
FENTANYL LOLLIPOP

24. Side effects
Sedation
Nausea
Constipation
tolerance
respiratory depression
dental decay
Each lozenge contains approx. 2grams of
sugar, and has issues for pre-diabetic users
and diabetic users.
FENTANYL LOLLIPOP