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.

 

 

 

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-drying^{8, 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 drying^{11, 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.

 

Sublimation^{5, 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 extrusion^{5, 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 process^{1, 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