You are hereFORMULATION AND EVALUATION OF TASTE MASKED ORODISPERSIBLE TABLETS BY ION – EXCHANGE RESINS

FORMULATION AND EVALUATION OF TASTE MASKED ORODISPERSIBLE TABLETS BY ION – EXCHANGE RESINS


PHARMACEUTICAL GRADE IER- INDION-

PRODUCT NAME

INDION 204

INDION 214

INDION 224

INDION 234

Applications

Taste masking of bitter drugs such as Norfloxacin, Ofloxacin

Taste masking of bitter drugs such as Azithromycin

Sustained release agent in drug formulations

Taste masking of bitter drugs such as Ciprofloxacin, Chloroquin phosphate


Matrix type

Cross linked polyacrylic

Cross linked polyacrylic

Styrene DVB

Cross linked polyacrylic

Functional Group

-coo-

-coo-

-SO3-

-coo-

Standard Ionic Form

H+

H+

H+

K+

Particle size range, mm

≤ 0.15

≤0.15

0.2 – 1.2

≤0.15

% Moisture

≤ 5

≤ 5

≤ 3

≤ 10

Total Exchange Capacity meq/g, dry

10.0

10.0

4.8

NA

  


PRODUCT NAME



INDION 234S


INDION 244


INDION 254


INDION 264

Applications

Taste masking of bitter drugs as well as tablet disintegration

Sustained release agent in drug formulations

Sustained release agent in drug formulations. Product meets specs. Of Sodium Polystyrene sulfonate , USP


Stabilization of Vitamin B12

Matrix type

Cross linked polyacrylic

Styrene/DVB

Styrene/DVB

Cross linked polyacrylic


Functional Group

-coo-

-SO3-

-SO3-

-coo-  


Standard Ionic Form

K+

H+

Na+

H+

Particle size range, mm

≤ 0.075

≤ 0.15

≤ 0.15

≤ 0.15

% Moisture

≤ 10

≤ 10

≤0.15

≤ 5

Total Exchange Capacity meq/g, dry

NA

4.5*

NA

10.0*


PRODUCT NAME


INDION 284

INDION 294

INDION 404

INDION 414

Applications

Sustained release agent in drug formulations

Tablet disintegrant/ Taste masking. Product meets specs. Of Polacrilin Potassium, USP


Treatment of hyperkalaemia. Product meets specs. Of Calcium polystyrene sulfonate, BP

As superdisintegrant in mouth disperse tablets, iron & calcium pellets

Matrix type

Styrene/DVB

Cross linked polyacrylic


Styrene/DVB

Cross linked polyacrylic

Functional Group


-SO3-

-coo-

-SO3-

-coo-

Standard Ionic Form

Na+

K+

Ca++

K+

Particle size range, mm

0.3 – 1.2

≤ 0.15

≤ 0.15

≤ 0.15

% Moisture

≤ 70

≤ 10

≤ 8

≤ 10

Total Exchange Capacity meq/g,


1.0

NA

NA

NA


PRODUCT NAME

INDION 454

INDION 464

Applications

Cholesterol reduction and taste masking of bitter drug

Taste masking of bitter substances Ex. Nicotine

Matrix type

Cross linked Polystyrene

Cross linked Polymethacrylic

Functional Group

- N+R3

- COO-

Standard Ionic Form

Chloride

H+

Particle size range, mm

≤0.15

≤ 0.15

% Moisture

≤12

≤ 5

Total Exchange Capacity meq/g,

N.A.

9.5

Desired properties of pharmaceutical grade IERs-
a) Fine, free flowing powders
b) Particle size of 25 - 150 microns
c) Contain functional group that capable of exchanging ions and/or ionic groups
d) Insoluble in all solvents, all pH’s
e) Not absorbed by body
f) Do not have a defined molecular weight

Advantages of Ion Exchange Resin as a Taste Masking Agent in Orodispersible Tablet-
1. These method requires few and simple equipment.
2. The numbers of excipients required are less and are easily available.
3. The Bioavailability of drug is not altered.
4. The resins are easy to process and has high margin of safety.
5. The manufacturing can be carried out at room temperature and no other special experimental conditions are required
6. It has low cost of manufacturing. (23)

TASTE MASKED ORODISPERSIBLE TABLETS HAVING IERs AS A TASTE MASKING AGENT-
1. FORMULATION OF TASTE MASKED ORO-DISPERSIBLE TABLETS OF METFORMIN HYDROCHLORIDE-
(27)
INTRODUCTION-
METFORMIN HYDROCHLORIDE is an oral biguinide agent, used in the management of non-insulin dependent (type-2) diabetes mellitus. The purpose of this article is to mask the taste of drug by complexation with indion-234 which is an IER & formulation of oro-dispersible tablet.

PREPARATION OF RESINATE-
Resinate was prepared using batch method. An accurately weighed amount of resin (100mg) was placed in a beaker containing 50 ml of demonized water. Accurately weighed100 mg of metformin hydrochloride was added to the resin solution and stirred for 180 min. The mixture was filtered through whatman filter paper and residue was washed with 50 ml of deionised water to remove any uncomplexed drug. Unbound drug in filtrate was estimated at 233.5 nm and drug-loading efficiency was calculated.

FORMULATION DESIGN-

EVALUATION OF TABLETS-

EVALUATION OF PHYSICAL CHARACTERISTICS OF TABLETS (BATCH B-1-B-8)-   

After evaluation Batch B-5 with 5% sodium starch glycolate and starlac and Batch B-8 with 5% sodium starch glycolate and avicel PH 101 was found to be optimum batch as it shows lowest disintegration time with desired friability values.

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