Role of Excipients to Enhance the Disintegration Property of Different Formulations: An Overview

 

Amit Alexander*, Ajazuddin, D K Tripathi, TekeshwarVerma, Sandip Patel,  Harsh Deshmukh, Swarna.

Rungta College of Pharmaceutical Sciences and Research, Bhilai. (CG)

*Corresponding Author E-mail: mailme_amitalex@yahoo.in

 

ABSTRACT:

Excipients perform major role in manufacturing of different tablet formulations. Excipients which mainly effect the disintegration time of any formulation are disintegrants, super disintegrants, polymers, surfactants etc. The technologies like spray drying, molding, cotton candy, lyophilization etc are generally employed for manufacturing of tablets such as dispersible tablet (DTs) and orodispersible tablets (ODTs) or fast dissolving tablets (FDTs) also effect disintegration time of these formulations. Exipients can act by different mechanism such as capillary action, capillary absoption, swelling action. Dispersible tablets cover broad advantages over other dosage forms, in respect to onset of action, bioavailability and patient compliance. These formulations provide better efficacy to treat the patient. Formulation of tablets along with disintegrantes/superdisintegrants or with other excipients which can enhance the solubility of dosage forms, so selection of better compatible excipients is necessary. Commonly used disintegrating agents are Isapghula hask, Cassia tora, Cassia nodosa, Crosslinked tragacanth which have been employed in much drug formulation. The study of different disintegrating substances in formulations gives important information for optimizing the dosage forms for better efficacy.

 

KEYWORDS: Superdisintegrants, Disintegrants, Polymers, Methods, Mechanism of action.

 


 

INTRODUCTION:

Despite of tremendous advancements in drug delivery, the oral route remains the most popular and convenient route for the administration of therapeutic agents because the low cost of therapy and ease of administration leads to high level of patient compliance. Patient convenience and compliance oriented research has resulted in bringing out safer and newer drug delivery systems.1

 

Drug release from a solid dosage form can be enhanced by addition of suitable disintegrants. In more recent years, increasing attention has been paid to formulating dispersible tablets that disperse in water, but also orally disintegrating tablets that are intended to dissolve and/or disintegrate rapidly in the mouth.

 

Disintegrants are substances or mixture of substances added to the drug formulation that facilitate the breakup or disintegration of tablet or capsule content into smaller particles that dissolve more rapidly than in the absence of disintegrants. Superdisintegrants are generally used at a low level in the solid dosage form, typically 1 – 10 % by weight relative to the total weight of the dosage unit.

 

Examples of superdisintegrants are crosscarmelose, crosspovidone, Sodium starch glycolate which represent example of crosslinked cellulose, crosslinked polymer and a crosslinked starch respectively; Natural Disintegrant are Isapghul husk, Cassia tora; Polymers like PEG-4000,PEG-6000, Hpmc etc;Surfactants which facilitate disintegration  Poloxamer, Tween 80;Excipients are Pharmaburst, Orocell 400 (Table. No.1,2,3,4,5).2 The objectives behind addition of disintegrants are to increase surface area of the tablet fragments and to overcome cohesive forces that keep particles together in a tablet.The drug will dissolve at a slower rate from a non disintegrating tablet due to exposure of limited surface area to the fluid.3

 

 


Table 1. Super disintegrants and techniques used to prepare DT/ODT/MDT/FDT

S.No

Drugs

Super Disintegrants

Category

Dosage Form

Techniques Involve

Mechanism of Dissolution

References

1

Ketoprofen    Famotidine   Loratadine mitraxepine Ondansetron

Crosspovidone cross, Carmellose sodium, Sodium  starch glycolate,

Acrylic acid derivative  Sodium  alginate

NSAID                 Antiulcer                     Anti histaminic.            Anti depp.       Antiemetic

 

ODT

Lyophilization / Freeze drying Molding          Cotton candy   Spray drying              Mass extrusion Compaction

Rapid absorption of water  Capillary action                     Chemical reaction

 

8

2

Ondansetron hcl

MCC (Avicel 102)

 

Antiemetic

ODT

Direct compression

Capillary absorption

9

3

Buspirone

 

Avicel

Pealitol sd 2oo

Anxiolytic

 

ODT

Wet granulation   Direct compression Freeze drying

Capillary absorption

 

10

 

4

Naproxen

Cross-linked polyvinyl pyrrolidone

NSAID

(non steroidal anti-inflammatory drugs)

DT

Drug loading on the surface of a carrier

Higher surface area of carrier and capillary action of carrier

11

5

Phenylbutazone

Sodium starch glycolate

NSAID

DT

Wet granulation

Swelling action

 

6

Nifedipine

Crosscarmellose sodium & crospovidone

Anti-anginal

DT

Physical mixture

Swelling action & capillary action

7

Oxazepam

Cross linked sodium (Acdisol)

Anxiolytic

DT

Ordered mixing

Swelling action

8

Furosemide

Crosspovidone

Loop diuretics

DT

Formation of coprecipittates by solvent method

Capillary action of carrier

9

Aspirin

Sodium starch glycolate Crosscarmellose sodium

Crospovidone

Anti-platelet

DT

Direct compression

Swelling action  of sodium starch glycolate crosscarmellose sodium  capillary action  of crospovidone

10

Tenoxicam

Primogel,

Acdisol,

 Kollidone cl

 

NSAID

(non steroidal anti-inflammatory drugs)

DT

Cooprecipitation/ solvent evaporation method

Swelling action  of sodium starch glycolate crosscarmellose sodium    & capillary action  of crospovidone

11

Isoniazide

Avicel

Acdisol Crosscarmellose sodium

Antidepressant

DT

Direct compression

Capillary absorption

12

12

Naproxem

Crosscarmellose sodium

NSAID

DT

Sublimation

Capillary absorption

13

13

Promethazine theoclate

Sodium starch glycolate 

Acdisol  Crosspovidone

Anti- histaminic with antimuscarinic

 

FDT

Direct compression

Swelling action  of sodium starch glycolate & capillary action  of crospovidone

 

14

14

Valsartan

Microcrystalline cellulose

 crospovidone

Acdisol

Sodium starch glycolate (SSG)

Angiotensin- ii receptor antagonist

FDT

Direct compression

Capillary absorption Swelling action

15

15

Chlorpromazine HCL

Sodium starch glycolate Crospovidone Croscarmellose

l-hpc pregelatinised

Antiemetic

FDT

Direct compression

Capillary action  Swelling action

16

16

Aceclofenac

Microcrystalline  cellulose Croscarmellose Crosspovidone sodium Starch glycolate

NSAID

FDT

Direct compression

Capillary absorption Swelling action

17

17

Zopicolon

Acdisol (Croscarmellose sodium)

Polyplasdone xl-10  Microcrystalline cellulose ph 102

Atypical anti-psychotic

MDT

Direct compression

Swelling action 

Capillary absorption

 

18

18

Tizanidine hydrochloride

Sodium starch glycolate Crosscarmellose sodium

Crosspovidone

Muscle relaxant

FDT

Mass extrusion

Swelling action   (sodium starch glycolate and crosscarmellose sodium) capillary action  of crospovidone

19

19

Promethazine hcl

Microcrystalline cellulose

(Avicel ph-101)  Starch

Motion Sickness

FDT

Direct compression

Capillary absorption

 

20

20

Aceclofenac

Sodium starch glycolate Crosscarmellose sodium

Crosspovidone

NSAID

FDT

Direct compression

Swelling action   (sodium starch glycolate and crosscarmellose sodium)  & capillary action  of crospovidone

21

21

Omeprazole and domperidone

 Kollidon cl

Acdisol

SSG

Prokinetc anti-emetic

FDT

Direct compression

 Capillary action Swelling action  

 

22

22

Sildenafil citrate

Sodium  starch glycolate Croscarmellose sodium

Crospovidone Microcrystalline cellulose starch

Erectile dysfunction

MDT

Direct compression

Capillary action Swelling action  

 

23

23

Granisetron HCL

Crospovidone

Sodium starch glycolate

Antiemetic

MDT

Direct compression

Capillary action

Swelling action  

 

24

24

Aceclofenac

Sodium  starch glycolate Croscarmellose sodium Crospovidone

NSAID

FDT

Direct compression

Capillary action             Swelling action  

 

25

25

Fenoverine

Sodium  starch glycolate Croscarmellose sodium Crospovidone

Anti spasmodic

FDT

Direct compression

Capillary action

Swelling action  

 

26

26

Olanzapine

Crospovidone 

Atypical anti psychotic

QDT

Direct compression

Capillary action

27

27

Etoricoxib

Hydroxypropyl methylcellulose

(l-hpmc) hydroxylpropyl cellulose (l-hpc)

Crospovidone

Croscarmellose sodium,

 Sodium  starch glycolate

Cox-2 inhibiter

O.D.T

Direct compression

Capillary action Swelling action

28

 

Table 2. Natural Disintegrants used to prepare dispersible tablet

S.No

Drugs

Disintegrants

Category

Dosage form

Techniques involve

Mechanism of dissolution

References

1

Norfloxacin

Isapghul husk

Cassia tora

Cassia tora (df)

Cassia nodasa

Antibiotic

DT

Direct compression

High swellability

6

2

Piroxicam

Isapghul husk

Cassia tora

Cross-linked tragacanth

NSAID

DT

Direct compression

High swellability

7

TABLE 3 Polymer used to prepare dispersible tablet

S.No

Drugs

Polymers

Category

 Dosage Form

Techniques

Involve

Mechanism of  Dissolution

References

1

Glyburide

Peg-4000

Peg-6000

Anti-diabetic

DT

Solid dispersion by fusion and solvent method

Increase in surface area & hence surface free energy resulting in an increase in the dissolution

11

2

Norfloxacine

Peg- 6000

Antibiotic

DT

Solid dispersion by fusion method

Solubilizing effect of peg on the drug

3

Piroxicam

Pvp k-30

NSAID

DT

Solid dispersion by fusion method

Increase in the drug wet ability & the presence of intermolecular hydrogen bound between piroxicam & pvp

4

Nifedipine, griseofulvin, indomethacin

Peg-6000-

HPMC

Anti-anginal

DT

Compaction process

Providing a lower energy pathway

5

Micronized danzol

Pvp k-15

Antibiotic

DT

Ultra-rapid freezing

Increases the solubility driving force, nanostructure amorphous drug domain & improve surface area

6

Prochlorperajin maleate tablet

HPMC

Hpmc

DT

Coevaporates

Solubilizing effect of carrier

7

Meloxicam

Peg 6000

peg 8000

peg 20000

lutrol f-127

β –cyclodextrin

NSAID

DT

Melting method

solid dispersion solvent evaporation method

 

Solubilizing effect of peg on the drug

29

Table 4 Surfactants and techniques used to prepare ODT (Orodispersible tablet)

S.No

Drugs

Surfactants

Category

Dosage Form

Techniques Involve

Mechanism of  Dissolution

References

1

Albendazole

Poloxamer   407

Wormicide

O.D.T

Solid dispersion by hot  melt method

Surface active property of the carrier, deceased cristilinity of product

11

2

Refecoxib

Poloxamers

NSAID

O.D.T

Solid dispersion by hot  melt method

Micellar solubilization &/or reduction of activity coefficient of the drug through reduction of

Hydrophobic reaction

3

Piroxicam

Labrasol

NSAID

O.D.T

Semi-solid dispersion

Increasing wetting and micellar solubilizatoin of drug

4

Piroxicam

Tween 80

NSAID

O.D.T

Liqisolid compact

Increasing wetting and surface availability of drug to the dissolution medium

Table 5 Approaches used for desired  disintegration purpose

S.No

Excipients

Drugs

Approaches  used

Result

References

1

Pharmaburst

Famotidine

Taste masking microsphere for orally disintegrating tablets using Eudragit- EPO and quick dissolving excipient Pharma-burst by spray drying

Disintegration in 30 seconds with improved taste.

30

 

2

Pharmaburst

Ondansetron   (gastroenteritis’

dehydration

Blended with conventional tableting aids. The excipient system is claimed to be of good flow characteristics and highly compressible such that robust tablets

Disintegration in 30 seconds with improved taste

31

3

Orocell 200 &

Orocell 400

 

Ibuprofen

Direct compressible

Disintegration time of 5 sec.

30

4

Orocell 200

Rizatriptan benzoate

 ( migraine)

Direct compressible

Disintegration time of 5 sec.

32

5

Orocell 200

Ibuprofen

Direct compressible

Disintegration time of 5 sec.

32

 

6

GalenIQ

720 and 721

(Yousef, 2005)

Placebo

 

Direct compressible

Even without superdisintegrants, tablets containing both isomalt grades disintegrated quickly, within 200–500 sec

30

 

7

GalenIQ

 

--

Direct compressible

Disintegrated quickly, within 200–500 sec

33

8

GalenIQ

 

--

Direct compression

Disintegrated quickly, within 200–500 sec

34

9

Polacrilin Potassium

Samaritan

Direct compression

Disintegration time of 45 s. 100%drug release in 10 min

 

30

1O

Polacrilin potassium

Ondansetron  HCL

 

Disintegration time of 45 s. 100%drug release in 10 min

 

 

35

11

Ludiflash

 

Risperidone

Direct compression

 

Disintegration time of  27 sec

30

Abbrevation

ODT-Orodispersible tablet ; FDT-Fast dissolving tablet ; DT-Dispersible tsblet ; MDT-Mouth dissolving tablet

QDT-Quick dissolving table ; NSAID-Non steroidal anti inflammatory drug

 

 

 


Difference between dispersible and orodispersible tablets

Dispersible tablets-Dispersible tablets are uncoated or film-coated tablets intended to be dispersed in water before administration giving a homogeneous dispersion.

 

Disintegration- Dispersible tablets disintegrate within 3 min when examined by the test for disintegration of tablets and capsules, but using water R at 15-25 °C.

 

Orodispersible tablets-Orodispersible tablets are uncoated tablets intended to be placed in the mouth where they disperse rapidly before being swallowed. Orodispersible tablets are also known as mouth dissolving tablets, quick disintegrating tablets, fast dissolving tablets, porous tablets.

 

Disintegration- Orodispersible tablets disintegrate within 3 min when examined by the test for disintegration of tablets and capsules.4

Methods of incorporating disintegrants4

·         Internal Addition (Intra-granular)

·         External Addition (Extra-granular)

·         Partly Internal and External

In external addition method, the disintegrant is added to the sized granulation with mixing prior to compression. In Internal addition method, the disintegrant is mixed with other powders before wetting the powder mixtures with the granulating fluid. Thus the disintegrant is incorporated within the granules. When these methods are used, part of disintegrant can be added internally and part externally. This provides immediate disruption of the tablet into previously compressed granules while the disintegrating agent within the granules produces further erosion of the granules to the original powder particles. The two step method usually produces better and more complete disintegration than the usual method of adding the disintegrant to the granulation surface only.

 

Ideal properties of disintegrants2

·         Poor solubility

·         Poor gel formation

·         Good hydration capacity

·         Good molding and flow properties

·         No tendency to form complexes with the drugs.

 

Mechanism of disintegration3

·         Capillary action

·         Swelling

·         Because of heat of wetting

·         Due to disintegrating particle/particle repulsive forces

·         Due to deformation

·         Enzymatic action

·         Chemical reaction (Acid base reaction)

 

Factors affecting action of disintegrants2

·         Percentage of disintegrants present in the tablets.

·         Types of substances present in the tablets.

·         Combination of disintegrants.

·         Presence of surfactants.

·         Hardness of the tablets.

·         Nature of Drug substances.

·         Mixing and Screening.

 

Methods of formulation

Lyophilization / Freeze-drying8, 11

Lyophilization is a process, which includes the removal of solvent from a frozen suspension or solution of drug with structure-forming additives. Freeze-drying of drug along with additives imparts glossy amorphous structure resulting in highly porous and lightweight product. The resulting tablet has rapid disintegration and dissolution when placed on the tongue and the freeze-dried unit dissolves instantly to release the drug several technologies are patented involving lyophilization process, which are discussed in this article. However, the ODTs formed by lyophilization have low mechanical strength, poor stability at higher temperature, and humidity. Along with above complications and its expensive equipment freeze-drying use is observed to be limited.

 

Spray drying11, 36

Drug is dissolved in suitable solvent and the required stoichiometric amount of carrier material is dissolved in water. Solutions are then mixed by sonication or other suitable method to a reduction in particle-particle agglomeration or by reducing van der Waal’s interactions. Increase in true surface area of the ordered powdered mixture is expected due to the inherent surface roughness and porosity of the microcrystalline cellulose-drug mixture.Spray drying technique produces highly porous and fine powders as the processing solvent is evaporated during this process.

 

Sublimation5, 37

Because of low porosity, compressed tablets composed of highly water-soluble excipients as tablet matrix material often do not dissolve rapidly in the water. Porous tablets that exhibit good mechanical strength. Inert solid ingredients (ex. urea, urethane, ammonium carbonate, camphor, naphthalene) were added to other tablet excipients and the blend was compressed into tablet. Removal of volatile material by sublimation generated a porous structure. A method of producing fast dissolving tablet using water as the pore forming material. Compressed tablets containing mannitol and camphor have been prepared by sublimation technique. The tablets dissolve within 10-20 seconds and exhibit sufficient mechanical strength for practical use.

 

Mass extrusion5, 8

The drug/carrier mix is typically processed with a twin-screw extruder. The drug/carrier mix is simultaneously melted, homogenized and then extruded and shaped as tablets, granules, pellets, sheets, sticks or powder. The intermediates can then be further processed into conventional tablets. An important advantage of the hot melt extrusion method is that the drug/carrier mix is only subjected to an elevated temperature for about 1 min, which enables drugs that are somewhat thermo labile to be processed.

 

Molding8

The molding technology results in tablets with an appropriate dissolution time, even though they are characterized by poor mechanical properties (hardness). [1] Molding process includes moistening, dissolving, or dispersing the drug with a solvent then molding the moist mixture into tablets (compression molding with lower pressure than conventional tablet compression), evaporating the solvent from drug solution, or suspension at ambient pressure (no vacuum lyophilization), respectively.

 

Cotton candy process1, 5, 8

This process is so named as it utilizes a unique spinning mechanism to produce floss-like crystalline structure which mimics cotton candy. Cotton candy process involves formation of matrix of polysaccharides or saccharides by points. Before heating process, the tablets do not have sufficient hardness because of low compatibility. The tablet hardness was increased after heating process, due to the increase of inter particle bonds or the bonding surface area in tablets induced by phase transition of lower melting point sugar alcohol.

 

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Received on 14.03.2011          Modified on 23.03.2011

Accepted on 11.04.2011         © RJPT All right reserved

Research J. Pharm. and Tech. 4(10): Oct. 2011; Page 1519-1525