Oral Dispersible System A New Approach in Drug Del PDF
Oral Dispersible System A New Approach in Drug Del PDF
Oral Dispersible System A New Approach in Drug Del PDF
Dosage form is a mean used for the delivery of drug to a living body. In order to get the desired effect the drug
should be delivered to its site of action at such rate and concentration to achieve the maximum therapeutic effect and
minimum adverse effect. Since oral route is still widely accepted route but having a common drawback of difficulty
in swallowing of tablets and capsules. Therefore a lot of research has been done on novel drug delivery systems.
This review is about oral dispersible tablets a novel approach in drug delivery systems that are now a day’s more
focused in formulation world, and laid a new path that, helped the patients to build their compliance level with
the therapy, also reduced the cost and ease the administration especially in case of pediatrics and geriatrics. Quick
absorption, rapid onset of action and reduction in drug loss properties are the basic advantages of this dosage form.
Key words: Fast dissolving/disintegrating tablets, orodispersible tablets, GIT, bioavailability, first pass metabolism,
superdisintegrants
Formulation of drugs into a presentable form is the diffusion, or through pores called pore diffusion.
basic requirement and need of today. Dosage form In pore diffusion the drug release rate is controlled
is a mean of drug delivery system, used for the by the crystal size, molecular size, pore size, pore
application of drug to a living body. Various type of structure and tortuosity of the polymers. In passive
dosage forms are available such as tablets, syrups, transport (Fick’s first law) the drug moves from high
suspensions, suppositories, injections, transdermal concentration to the low concentration, while in active
and patches having different type of drug delivery transport energy is required for the movement of drug
mechanisms. These classical/modern dosage forms from low to high concentration region through one
have some advantages and disadvantages therefore or more transport mechanisms. It requires energy or
the development of an ideal drug delivery system carrier such as enzyme, protein[1].
is a big challenge to the pharmacist in the presence
scenario. In order to get the desired effect the drug GENERAL CONSIDERATIONS IN
should be delivered to its site of action at such DOSAGE FORM DESIGN
rate and concentration to achieve the maximum
therapeutic effect and minimum adverse effect. For Several physicochemical properties should be
the development of a suitable dosage form a thorough considered before going for new dosage form. The
study about the physicochemical principles that major aspects to be considered during formulation
governs a specific formulation of a drug should be of a dosage form are mentioned as, the formulation
subjected[1]. qualifying the target parameters is considered as
During establishing dosage form for a drug, it This is an open access article distributed under the terms of the Creative
Commons Attribution‑NonCommercial‑ShareAlike 3.0 License, which allows
requires knowledge about each ingredient i.e. physical, others to remix, tweak, and build upon the work non‑commercially, as long as the
author is credited and the new creations are licensed under the identical terms.
chemical and biological properties along with the
For reprints contact: reprints@medknow.com
compatibility with the active drug, so that the product
formed should be palatable, stable and efficacious[2].
Accepted 02 February 2016
Most drugs pass through the barrier by molecular Revised 12 November 2015
*Address for correspondence Received 02 December 2014
E-mail: peer_hannan@yahoo.com Indian J Pharm Sci 2016;78(1):2‑7
master formulation and any batch formulated must swallowing bulky conventional dosage forms [12]. In
be on the specifications of master formula. Active order to prevent the dysphagia and improve patient
agent can be incorporated in many dosage forms in compliance, orodispersible tablets are introduced as
such a way to achieve a convenient and efficacious a substitute in oral DDS, designed to disintegrate in
drug delivery system for the treatment of diseases mouth without the aid of water. So they are useful
based on the route of administration. For oral use in such conditions in which water is not available,
tablets and capsules are prepared for systemic effect or prohibited as before operation, in kinetosis,
as they can be easily handled by most of the patients, cough episodes due to neurological stimulation or
and if intended in emergency condition injectable chest infections. Different methods are adopted to
form is applied for quick results. Other dosage forms manufacture the orodispersible tablets with the aim
include the patches and suppositories can be applied of giving fast disintegration to the dosage form as
according to the patient condition[1]. it gets in contact with saliva with good agreeable
moth feeling[13]. These orodispersible tablets (ODT)
NEED OF INNOVATIVE DRUG can be administered to any patients having difficulty
DELIVERY SYSTEM in swallowing. They are also recognized as mouth
dissolvable, melt-in-mouth, fast dissolving, rapi-melts
The orally administered drug delivery is still or porous tablets[14].
considered as a standard system in pharmaceutics field
and still considered safest, convenient and economical These are tablets which get dispersed or disintegrate
method of administration providing best route for when gets in a contact with saliva with the
patient compliance[3], however in case of tablet and release of active drug [15,16] , providing maximum
capsule having a common drawback of difficulty in drug bioavailability as compared to conventional
swallowing leading to poor compliance specially in dosage form [17]. This dispersible property is given
geriatrics[4]. by the addition of superdisintegrants to the dosage
form, that releases the drug in mouth increasing
To improve compliance and making the administration the bioavailability[18]. Three different methods for
convenient, design of new dosage forms gained the addition of disintegrants are used, they are
significant importance. Conventional oral drug intra granular (within the granules), extra granular
delivery present a drug with quick and full release (addition after granulation) and combination of both
that may go as such without producing the desired processes[19].
effect may be due to the presence of food, pH
of the stomach, enzymatic degradation, change in Te best time for an orodispersible tablet to get
GIT motility as so forth, giving not enough time disperse is considered to be less than a minute[20,21].
to get absorbed [5,6]. Recently much light is being Mostly the disintegration times varies from
put on the area of designing drug delivery systems 5 to 30 seconds and are prepared applying; direct
bearing organoleptic elegancy and maximum patient compression, solid dispersion, lyophilization or
acceptability in pediatrics and geriatric groups [7-9]. molding techniques. In all these methods direct
A lot of innovative work is being done on drug compression is preferred because of its effortlessness,
delivery in which oral route is preferred because of quick procedure and cost effectiveness [22] .
ease of administration, cost effective therapy, self ODTs are developed by the addition of super
medication and noninvasive method leading to patient disintegrants like cross linked cellulose derivative;
compliance to a higher level[10]. Tablet coating is one carboxymethyl cellulose, sodium starch glycolate,
of the parameter in drug delivery designing applied polyvinylpyrollidone, which gives burst disintegration
to minimize the bad tasting and side effects while when gets in contact with water or salivary secretions.
enhancing elegancy and drug bioavailability[11]. Bioavailability of drugs may rise due to oral and
pregastric absorption, reducing first pass metabolism
ORAL DISPERSIBLE TABLETS in gastrointestinal tract[23].
Drinking water is mostly required for the oral Prerequisite of fast disintegrating tablets:
administration of drugs, like tablet and capsules, There are some prerequisite for fast disintegrating
in which some patients experience nuisance in tablets which are mentioned as, Tablet must
January - February 2016 Indian Journal of Pharmaceutical Sciences 3
www.ijpsonline.com
disintegrate and disperse in oral cavity without apomorphine and buspirone. Drugs producing
water intake. It can hold high drug quantity. It considerable amounts of toxic metabolites on first
should be compatible with taste masking agents pass metabolism and in GIT and having substantial
and excipients, and have optimum sensation effect. absorption in oral and pregastric areas are good
Leave minimum to no residue after administration. candidates. Drugs permeable to upper GIT and oral
It should have optimum capacity to remain intact mucosal epithelial cell lining are considered good
in formulation processes. It should be stable at the candidates for FDT[25].
range of temperature and humidity. It should be
adaptable and amenable to existing processing and Drugs which can be integrated in the fast
packaging machinery. It should be manufactured at dissolving tablets:
low cost[22,24]. A variety of drugs are being incorporated in FDTs.
Examples of drug candidates in various classes are
Suitability of drugs for fast disintegrating tablets: mentioned in Table 1[26,27].
For developing FDT of a specific drug several
factors should be kept forth while selecting drug, Excipients required in formulating FDTs:
excipients and formulation method. These are as Excipients used in FDTs contain one
follows: Dugs to be used for sustained action are superdisintegrant, a diluent/bulking agent, a lubricant
not suitable candidate for FDT. Drugs having very and optionally swelling agent, a permeabilizing
disagreeable taste are not suitable like clopidogrel. agent (depending upon drug nature), sweeteners and
Patients suffering from Sjogren’s syndrome and flavorings agents. Names of excipients classes and
those with less saliva secretion and not suitable their percentages are given in Table 2[28].
for FDT dosage form. Drugs of very short half life
and requiring frequent dosing are not appropriate TECHNIQUES FOR PREPARING
candidate. Patients on anticholinergic therapy ORODISPERSIBLE TABLETS
are not suitable for FDT. Drugs showing altered
pharmacokinetic behavior if formulated in such Various techniques are currently used in preparing
dosage form with respect to their conventional fast disintegrating/dissolving tablets; some of them are
dosage form are not suitable, like selegiline, discussed briefly in the following section.
during swallowing[38]. Provide medication in dissolved 16. Redkar M, Gore S, Devrajan P. D-zolv taste masked mouth dissolving
tablet. Indian J Pharm Sci 2002;3:291-92.
or dispersed form through solid dosage form[39]. 17. Yeola BS, Pisal SS, Paradkar AR, Mahadik KR. New drug delivery
systems for elderly. Indian Drugs 2000;7:312-18.
APPLICATIONS 18. Masareddy RS, Kadia RV, Manvi FV. Development of mouth dissolving
tablets of clozapine using two different techniques. Indian J Pharm Sci
2008;70:526-8.
Numbers of drugs are being marketed applying 19. Sekar V, Chellan VR. Immediate release tablets of telmisartan using
different methods of formulating ODTs. List of some superdisintegrant-formulation, evaluation and stability studies. Chem
Pharm Bull (Tokyo) 2008;56:575-7.
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Table 3[28]. Expert Opin Therapeut Patents 2001;6:981-6.
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Pharm Sci 2002;15:295-305.
Financial support and sponsorship: 22. Abdelbary G, Prinderre P, Eouani C, Joachim J,
Nil. Reynier JP, Piccerelle P. The preparation of orally disintegrating tablets
using a hydrophilic waxy binder. Int J Pharm 2004;278:423-33.
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Conflicts of interest:
J Chem Pharm Res 2009;1:163-77.
There are no conflicts of interest. 24. Shukla D, Chakraborty S, Singh S, Mishra B. Mouth dissolving tablets
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