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8/10/2019 Formulation and Evaluation of Glipizide
1/25
Review of Literature
Drug profile
Diltiazem Hydrochloride
Synonym : Cardizem
CAS No : 33286-22-5
Chemical Name : (2S-Cis)3- (Acetyloxy)-5-[2-(Dimethylamino)ethyl]-
2,3-dihydro-2-(4-Methoxyphenyl) -1,5-benzo thiazepin
4(5H)-One HydrochlorideMolecular Structure :
Molecular Formulae : C22H26N2O4S.Hcl
Molecular Weight : 450.98 gm
Category : Calcium Channel Blocker, Anti Hypertensive
Solubility : Soluble in Water, Methanol, Formic Acid
Appearance : White to Off White Powder
Long Term Storage : +20C
Purity : 99% (HPLC)
Log P Value : 4.53
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Brand Names
Cardizem
CardizemCD
CardizemLA
CardizemSR
Cartia XT
Dilacor XR
Dilt-CD
Mechanism:
Diltiazem is a potent vasodilator, increasing blood flow and variably decreasing the
heart rate via strong depression of A-V node conduction. Its pharmacological activity is
somewhat similar to verapamil. Potent vasodilator of coronary vessels. Vasodilator of
peripheral vessels. This reduces peripheral resistance and afterload.
Negative inotropic effect : Diltiazem causes a modest decrease in heart muscle contractility
and reduces myocardium oxygen consumption.
Negative chronotropic effect: Diltiazem causes a modest lowering of heart rate. This effect
is due to slowing of the SA (sinoatrial) node. It results in reduced myocardium oxygen
consumption.
Negative dromotropic effect : By slowing conduction through the AV (atrioventricular)
node, diltiazem increases the time needed for each beat. This results in reduced
myocardium oxygen consumption by the body.
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Contra-Indications And Precautions:
CHF Patients with reduced ventricular function may not be able to counteract the
inotropic and chronotropic effects of diltiazem, the result being an even higher
compromise of function.
SA node or AV conduction disturbances : Use of diltiazem should be avoided in patients
with SA or AV nodal abnormalities, because of its negative chronotropic and
dromotropic effects
Low blood pressure : Patients with systolic blood pressures below 90 mm Hgshould not be treated with diltiazem.
Wolff-Parkinson-White syndrome : Diltiazem may paradoxically increase ventricular
rate in patients with WPW syndrome because of accessory conduction pathways.
Drug Interactions :
Beta-blockers : Intravenous diltiazem should be used with caution with beta-
blockers because, while this combination is most therapeutically beneficial, there are rare
instances of dysrhythmia and AV node block.
Quinidine : Quinidine should not be used concurrently with calcium
channel blockers because of reduced clearance of both drugs and potential
pharmacodynamic effects at the SA and AV nodes.
Miscellaneous : Diltiazem and verapamil inhibit hepatic cytochromes
CYP3A4, CYP2C9 andCYP2D6,possibly resulting in drug interactions.
http://en.wikipedia.org/wiki/Congestive_heart_failurehttp://en.wikipedia.org/wiki/Congestive_heart_failurehttp://en.wikipedia.org/wiki/Heart_blockhttp://en.wikipedia.org/wiki/Hypotensionhttp://en.wikipedia.org/wiki/Wolff-Parkinson-White_syndromehttp://en.wikipedia.org/wiki/Quinidinehttp://en.wikipedia.org/wiki/CYP3A4http://en.wikipedia.org/wiki/CYP2C9http://en.wikipedia.org/wiki/CYP2D6http://en.wikipedia.org/wiki/CYP2D6http://en.wikipedia.org/wiki/CYP2C9http://en.wikipedia.org/wiki/CYP3A4http://en.wikipedia.org/wiki/Quinidinehttp://en.wikipedia.org/wiki/Wolff-Parkinson-White_syndromehttp://en.wikipedia.org/wiki/Hypotensionhttp://en.wikipedia.org/wiki/Heart_blockhttp://en.wikipedia.org/wiki/Congestive_heart_failure8/10/2019 Formulation and Evaluation of Glipizide
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Side Effects:
A red, blistering skin rash, swelling in your hands or feet
trouble in breathing, slow heartbeats, fast or pounding heartbeat
dizziness, fainting, itching,
upper stomach pain, loss of appetite, dark urine, clay-colored stools,
jaundice
severe skin reaction -- fever, sore throat, swelling in your face or tongue,
burning in your eyes, skin pain, followed by a red or purple skin rash that
spreads) and causes blistering and peeling.
Less serious diltiazem side effects may include:
headache, dizziness, weakness, tired feeling, nausea
upset stomach, sore throat, cough, stuffy nose, flushing
Dosage:
The dose of Diltiazem in Supraventricular tachycardias is 0.25 mg/kg slow IV
push. Most commonly, a 20 mg IV dose is given to the average size patient
Dosing Information :
Usual Adult Diltiazem Dose for Hypertension:
Initial dose: 30 to 60 mg orally 3 to 4 times a day.
Maintenance dose: 180 to 360 mg orally/day in divided doses.
Initial bolus doses : 0.25 mg/kg as a bolus administered over 2 minutes.
A second bolus of 0.35 mg/kg may be used if necessary.
Initial infusion dose : 5 mg/hr.
Maintenance infusion dose : The infusion rate may be increased in 5 mg/hr increments up
to 15 mg/hr.
http://en.wikipedia.org/wiki/Supraventricular_tachycardiahttp://en.wikipedia.org/wiki/Supraventricular_tachycardia8/10/2019 Formulation and Evaluation of Glipizide
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Usual Adult Diltiazem Dose for Atrial Fibrillation:
Initial dose (oral): 30 to 60 mg orally 3 to 4 times a day.
Maintenance dose: 180 to 360 mg orally/day in divided doses.
Initial dose (IV): 0.25 mg/kg actual body weight bolus over 2 minutes. If necessary, a second
bolus of 0.35 mg/kg ABW may be given. In some cases, an infusion of diltiazem 5 mg/hour
may be started, and advanced in 5 mg/hour increments to 15 mg/hour for up to 24 hours.
Usual Adult Diltiazem Dose for Atrial Flutter:
Initial dose (oral): 30 to 60 mg orally 3 to 4 times a day.
Maintenance dose: 180 to 360 mg orally/day in divided doses.
Initial dose (IV) : 0.25 mg/kg actual body weight bolus over 2 minutes. If necessary, a second
bolus of 0.35 mg/kg ABW may be given. In some cases, an infusion of diltiazem 5
mg/hour may be started, and advanced in 5 mg/hour increments to 15 mg/hour for up to
24 hours.
Usual Adult Diltiazem Dose for Supraventricular Tachycardia:
Initial dose (oral): 30 to 60 mg orally 3 to 4 times a day.
Maintenance dose: 180 to 360 mg orally/day in divided doses.
Initial dose (IV) : 0.25 mg/kg actual body weight bolus over 2 minutes. If necessary, a second
bolus of 0.35 mg/kg ABW may be given. In some cases, an infusion of diltiazem 5
mg/hour may be started, and advanced in 5 mg/hour increments to 15 mg/hour for up to
24 hours.
Usual Adult Diltiazem Dose for Angina Pectoris Prophylaxis:
Initial dose: 30 to 60 mg orally 3 to 4 times a day.
Maintenance dose: 180 to 360 mg orally/day in divided doses.
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Excipients profile
Mannitol:
Mannitol occurs as a white, odourless, crystalline powder, or free-flowing granules. It
has a sweet taste, approximately as sweet as glucose and half as sweet as sucrose, and imparts a
cooling sensation in the mouth.
Description of mannitol
a) Synonyms
Cordycepic acid; E421; manna sugar; D-mannite; Mannite; Mannogem; Pearlitol.
b) Chemical name and CAS registry number
D-Mannitol [69-65-8]
c) Empirical formula and molecular weight
Empirical Formula : C6H14O6
Molecular weight : 182.17
d) Structural Formula
e) Functional Category
Diluent; diluent for lyophilized preparations; Sweetening agent; Tablet and Capsule
diluents; Tonicity agent.
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Applications in pharmaceutical formulation or technology
In pharmaceutical preparations it is primarily used as a diluent (1090% w/w) in
tablet formulations, due to its non hygroscopic nature and may thus be used with moisture-
sensitive active ingredients. Mannitol may be used in direct-compression tablet applications, for
which the granular and spray-dried forms are available. Specific tablet applications include
antacid preparations, and Vitamin preparations. Mannitol is commonly used as an excipient in
the manufacture of chewable tablet formulations because of its negative heat of solution,
sweetness, and mouth feel.
Solubility of mannitol
Freely soluble in water. Practically insoluble in ether.
Incompatibilities of mannitol
Mannitol solutions, 20% w/v or stronger, may be salted out by potassium chloride or
sodium chloride. Mannitol is incompatible with Xylitol infusion and may form complexes with
some metals such as Aluminum, Copper, and Iron. Reducing sugar impurities in mannitol have
been implicated in the oxidative degradation of a peptide in a lyophilized formation. Mannitol
was found to reduce the oral bioavailability of Cimetidine compared to sucrose.
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Microcrystalline cellulose (MCC)
Microcrystalline cellulose occurs as a white, odourless, tasteless, crystalline
powder composed of porous particles.
Description of microcrystalline cellulose (MCC)
a) Synonyms
Avicel PH; Celex; Cellulose gel; Celphere; Ceolus KG; Crystalline cellulose; E460; Emcocel;
Ethispheres; Fibrocel; Pharmacel; Tabulose; Vivapur.
b) Chemical name and CAS Registry Number
Cellulose [9004-34-6]
c) Empirical formula and molecular weight
(C6H10O5) n 36 000, Where n 220.
d) Structural formula
e) Functional Category
Adsorbent, Suspending agent, Tablet and Capsule diluents, Tablet disintegrant.
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Applications in pharmaceutical formulation or technology
Microcrystalline cellulose is widely used in pharmaceuticals, primarily as a
binder/diluent in Oral tablet and capsule formulations where it is used in both wetgranulation and
direct compression processes. In addition to its use as a binder/diluent, microcrystalline cellulose
also has some lubricant and disintegrant properties that make it useful in tableting.
Solubility of microcrystalline cellulose
Slightly soluble in 5% w/v sodium hydroxide solution; practically insoluble in water, dilute
acids, and most organic solvents.
Incompatibilities of MCC
Microcrystalline cellulose is incompatible with strong oxidizing agents.
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Sodium starch glycolate
Sodium starch glycolate is a white to off-white, odourless, tasteless, freeflowing powder.
The Ph Eur 2005 states that it consists of oval or spherical granules, 30-100 m in diameter, with
some less-spherical granules ranging from 10-35 m in diameter.
Description of sodium starch glycolate
a) Synonyms
Carboxymethyl starch, Sodium salt; Explosol; Explotab; Glycolys; Primojel; Starch
carboxymethyl ether, Sodium salt; Tablo; Vivastar P.
b) Chemical name and CAS registry number
Sodium carboxymethyl starch [9063-38-1]
c) Empirical formula and molecular weight
The PhEur 2005 describes three types of material: Types A and B occurs as the sodium
salt of a cross-linked partly O-carboxymethylated potato starch, containing 2.8-4.2% and 2.0-
3.4% of sodium respectively. Type C is the sodium salt of a cross-linked by physical
dehydration, partly Ocarboxymethylated starch containing 2.8-5.0% sodium. Sodium starch
glycolate may be characterized by the degree of substitution and cross linking. The molecular
weight is typically 5 105-1 10
6.
d) Structural formula
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e) Functional category
Tablet and capsule disintegrant.
Applications in pharmaceutical formulation or technology
Sodium starch glycolate is widely used in oral pharmaceuticals as a disintegrant in
Capsule and Tablet formulations. It is commonly used in tablets prepared by either direct
compression or wet-granulation processes. The usual concentration employed in a formulation is
between 2% and 8%. Disintegration occurs by rapid uptake of water followed by rapid and
enormous swelling. Although the effectiveness of many disintegrants is affected by the presence
of hydrophobic
excipients such as lubricants, the disintegrant efficiency of sodium starch glycolate is
unimpaired. Increasing the tablet compression pressure also appears to have no effect on
disintegration time.
Solubility of sodium starch glycolate
Sparingly soluble in ethanol (95%); practically insoluble in water.
Incompatibilities sodium starch glycolate
Sodium starch glycolate is incompatible with ascorbic acid.
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Literature review
Koizumi K et al., presented an invention, which related to rapidly dissolving tablets using
sublimation technique. Compressed tablets of Mannitol did not dissolve in water due to
the low porosity. To increase the porosity of tablets sublimation was done. Tablets were
prepared by direct compression containing mannitol and camphor. A high porosity was
achieved due to formation of many pores due to camphor sublimation. The compressed
tablets have high porosity (approximately 30%) rapidly dissolved within 15 seconds in
saliva.
Remon JP et al., prepared the rapidly disintegrating tablets by lyophilization. Tablets
contained hydrochlorothiazide, Maltrodextrin, hydroxyethylcellulose and gelatine. The
solutions were poured into blisters and freeze dried. Maltrodextrin could be a filler of
choice for the production of lyophilized tablets as freeze-drying due to amorphous
network, which dissolved in the water with seconds. They evaluated gelatine, xanthan
gum and hydroxyethylcellulose a binding agents in the formulation of freeze dried tablets
with Maltrodextrin as filling agents.
Nayak SM et al., prepared fast dissolving tablets of Promethazine theoclate using
effervescent melt, super disintegration addition and melt technologies.Tablets from
effervescent melt and super disintegration addition technique released 92 % and 89 % of
the drug at the end of 10 min.
Shirwaiker AA et al., prepared fast disintegrating tablets of Atenolol. The preparation
contained an active ingredient, sugar (mannitol), superdisintegrant and dicalciumphosphate. Required quantities of each ingredient were weighed, mixed and prepared the
tablets by dry granulation. All the formulation had disintegration time of less than 70
seconds. Among the three superdisintegrant Ac-Di-Sol showed the highest efficacy.
Formulation containing 10 % Ac-Di-Sol showed the least disintegration time of 30 2
seconds compare to Explotab and Polyplasdone X.
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Amin PD et al., presented an invention, which relates to fast disintegration tablets for oral
administration. Taste masked adsorbents of Ofloxacin were prepared using cationic
exchange resins. Taste evaluation of tablets showed complete masking of the bitterness of
Ofloxacin. The taste-masked complex of the Ofloxacin was further incorporated into
mouth dissolve tablets in combination with Metronidazole benzoate. All the formulation
exhibited an in vitro dispersion time less than 50 seconds.
Chaudhari PD et al., prepared fast dissolving tablets of Famotidine. In this study the
bitter taste of Famotidine was masked using drug: Eudragit E 100 in different ratios (1:1
to 1:10). For taste masking the ratio was optimized to 1:4 by time intensity. The different
superdisintegrant (Ac-Di-Sol, Polyplasdone) with their varying concentration were used
for disintegration of tablets in mouth. The formulation containing 2 % of Ac-Di-Sol and
Polyplasdone showed 91.89 % and 101.07 % release respectively in 12 min
Halakatti PK et al., formulated rapidly disintegrating tablets of Domperidone by applying
two methods. Sodium starch glycolate and treated agar used as superdisintegrants in mass
extrusion technique and treated agar method respectively.
Shirwaikar A et al., formulated and evaluated fast dissolving tablets of Granisetron
hydrochloride by direct compression method using superdisintegrants. A combination of
mannitol and silicified microcrystalline cellulose (SMCC) in the ration 70:30 was used in
the study. Study concluded that crospovidone and croscarmellose sodium are better
disintegrant for formulation of fast dissolving tablets of Granisetron HCl.
Vijaya KS et al., prepared Meloxicam rapidly disintegrating tablets by direct
compression. The tablets were prepared with three superdisintegrant like SSG, Ac-Di-Sol
and L-HPMC. The hardness of tablets was found to be less than 10% and disintegration
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time of tablets was found to be less than 1 minute, except LHPMC.In-vitro drug release
study showed enhance dissolution rate compared to pure Meloxicam.
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Materials and equipments
Analytical methods
Formulation of fast dispersable Tablets Of Diltiazem Hydrochoride
MATERIALS & EQUIPMENTS
The following materials those were either AR/LR grade or the best possible
pharmaceutical grade were used as supplied by the manufacturer.
S.No Materials Category
1
2
3
4
5
6
7
Diltiazem
Potato Strach
Primogel
Micro Crystalline Cellulose
Mannitol
Magnesium Stearate
Talc
Active Ingredient
Disintegrant
Super Disintegrant
Directly Compressible Vehicle
Directly Compressible Vehicle
Lubricant
Glidant
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ANALYTICAL METHODS
Determination of max of Diltiazem Hydrochloride by UV analysis
25 mg of Diltiazem Hydrochloride was accurately weighed and dissolved in 25 ml
of Distilled Water to get 1 mg/ml solution. This solution was further diluted to get 6g/ml. UV
spectrum was recorded in the wavelength range of 200 - 400 nm. The l max of drug was
determined by UV-Visible Spectrophotometer using Distilled Water as a blank.
Construction Of Calibration Curve Of Diltiazem Hydrochloride
25mg of Diltiazem Hydrochloride was accurately weighed and dissolved in 25ml of
water to get 1mg/ml solution. From this Solution,1ml was taken and dissolved in 10ml Distilled
Water. This solution was then serially diluted with Distilled water to give solutions of
concentration ranging from 2 mg/ml to 10 mg/ml. The absorbances of these solutions were
measured at 240 nm using Distilled Water as table blank and standard graph was plotted.
S.No Equipment
1
2
3
4
5
6
Monsanto Hardness Tester
Friability Tester
Tablet Dissolution Tester (USP)
Tablet Disintegration Test Machine
Tablet Punching Machine
UV-Visible Spectrophotometer
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Physical Properties
Angle of Repose ()
The frictional forces in a loose powder can be measured by the angle of repose (). It is an
indicative of the flow properties of the powder. It is defined as the maximum angle possiblebetween the surface of a pile of powder and the horizontal plane. Angle of repose was
determined by using funnel method. Powder was poured from funnel, which can be raised
vertically until a maximum cone height, h, was obtained. Diameter of heap, D, was measured.
The repose angle, , was calculated by formula,
= Tan-1 (2h/D)
Flow properties for different values of angle of repose are given below.
S.No Angle Of Repose Flow
1
2
3
4
40
Excellent
Good
Moderate (addition of 0.2% glident is required)
Poor
Table : Relationship between Powder Flow and Angle of Repose
Bulk Density (Db)
It is the ratio of total mass of powder to the bulk volume of powder. It was measured by pouring
the weighed amount of powder (passed through standard sieve #20) into a measuring cylinder
and the initial volume was noted. From this, the bulk density is calculated according to the
formula mentioned below. It is expressed in g/ml and is given by,
Db = M / V0
Where, M is the mass of powder
V0 is the bulk volume of the powder.
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a. Tapped Density (Dt)
It is the ratio of total mass of powder to the tapped volume of powder. The volume was measured
by tapping the powder for 500 times. Then the tapping was done for 750 times and the tapped
volume was noted, if the difference between these two volumes is less than 2%. And if it is more
than 2%, tapping is continued for 1250 times and tapped volume was noted. Tapping was
continued until the difference between successive volumes is less than 2% (in a bulk density
apparatus). It is expressed in g/ml and is given by,
Dt = M / Vt
Where, M is the mass of powder
Vt is the tapped volume of the powder.
b. Compressibility Index (Carrs Consolidation Index)
One of the method of measurement of free flowing powder is compressibility as computed from
density of a powder. It was calculated by using the formula,
% Compressibility = [Tapped density-bulk density/tapped density] x 100
Percentage Compressibility Flow Description
5-15
12-16
18-21
23-28
28-35
35-38
>40
Excellent (free flowing granules)
Excellent (free flowing granules)
Fair (powdered granules)
Poor (very fluid powder)
Poor (fluid cohesive powder)
Very poor (fluid cohesive powder)
Extremely poor (cohesive powder)
Table : Relationship between Powder Flow and Percentage Compressibility
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c. Hausner Ratio
Hausner ratio is an indirect index of ease of powder flow. If the hausner ratio of powder is near
to 1.25, indicates better powder flow. It is calculated by the formula,
Hausner Ratio = Dt / DbWhere, Db = Bulk density of the powder
Dt = Tapped density of the powder
Table : Relationship between Powder Flow and Hausner Ratio
Hausner Ratio Flow Description
1-1.11
1.12-1.18
1.19-1.25
1.26-1.34
1.35-1.45
1.46-1.56
Excellent
Good
Fair
Passable
Poor
Very Poor
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Formulation And Development of Dispersible Tablet
Of Diltiazem Hydrochloride
Formulation development:
Formulation of Diltiazem Hydrochloride Dispersible tablets by direct compression involve use of
mannitol, and microcrystalline cellulose as diluent, mannitol also used as sweetener. Talc as
glident and magnesium stearate as lubricant. Sodium starch glycolate (Primojel) was used as
superdisintegrant. To select best formulation effective concentration various batches were taken
at different concentration range from 4 to 8 % w/w for each superdisintegrant.
Formulations:
Formulation 1:
S.No Ingridents
Formulations
F1 F2 F3
1
2
3
4
5
6
7
Diltiazem Hydrochloride
Potato Strach
Primogel
Magnesium Stearate
Talc
Micro Crystalline Cellulose
Mannitol
30
18
3.8
3.6
3.6
60.5
60.5
30
18
10.8
3.6
3.6
57
57
30
18
14.4
3.6
3.6
50.2
50.2
Table : Composition of formulations F1,F2 & F3
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Procedure:
Mix Diltiazem Hydrochloride, Potato Strach, Primogel, Micro Crystalline Cellulose,
Mannitol And Sift Through # 80 Sieve
Load sifted material of Step-1 into Mortar & Pestle and mix for 15 Mins.
Lubricate the blend of Step-2 with # 80 passed Magnesium Stearate using Mortar &
Pestle for 2 minutes.
Add Talc as Glident to the Blend in Step-3 which was passed through # 80 Sieve
Compress the blend of Step-4 into tablet using Cad-mach Punching Machine to a tablet
of 180mg.
Formulation 2:
S.No Ingridents
Formulations
F4 F5 F6
1
2
3
4
5
6
Diltiazem Hydrochloride
Potato Strach
Primogel
Magnesium Stearate
Talc
Mannitol
30
18
3.8
3.6
3.6
121
30
18
10.8
3.6
3.6
114
30
18
14.4
3.6
3.6
110.4
Table : Composition of formulations F4,F5 & F6
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Procedure:
Mix Diltiazem Hydrochloride, Potato Strach, Primogel, Mannitol And Sift Through # 80
Sieve
Load sifted material of Step-1 into Mortar & Pestle and mix for 15 Mins.
Lubricate the blend of Step-2 with # 80 passed Magnesium Stearate using Mortar &
Pestle for 2 minutes.
Add Talc as Glident to the Blend in Step-3 which was passed through # 80 Sieve
Compress the blend of Step-4 into tablet using Cad-mach Punching Machine to a tablet
of 180mg.
Evaluation of Dispersible Tablets Of Diltiazem
Hydrochloride:
General Appearance and Organoleptic PropertiesThe control of a general appearance of a tablet involves the measurement of
a number of attributes such as a tablets size, shape, color, presence or absence of anodour, taste,
surface texture, physical flaws and consistency, and legibility of any identifying markings.
Shape, Thickness and Dimension
Six tablets of each batch were selected and measured for thickness and diameter
using digital vernier calipers. The extent to which the thickness of each tablet deviated from 5% of the standard value was determined. Hardness of the tablet was determined by Monsanto
Hardness Tester. The tester consists of a barrel containing a compressible spring held between
two plungers. The lower plunger is placed in contact with the tablet, and zero reading is taken.
The upper plunger is then forced against a spring by turning a threaded bolt until the tablet
fractures. As the spring is compressed, a pointer rides along a gauge in the barrel to indicate the
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force. The force of fracture is recorded, and the zero force reading is deducted from it. Six tablets
from each batch were selected and evaluated, and the average value with standard deviation was
recorded.
Friability Test
It is the phenomenon whereby tablet surfaces are damaged and/or show evidence
of lamination or breakage when subjected to mechanical shock or attrition. The friability of
tablets was determined by using Roche Friabilator. It is expressed in percentage (%). Ten tablets
were initially weighed (Winitial) and transferred into friabilator. The friabilator was operated at
25 rpm for 4 minutes or run up to 100 revolutions. The tablets were weighed again (Wfinal). The
percentage friability was then calculated by,
F = WinitialWfinal x 100
W initial
% Friability of tablets less than 1% is considered acceptable. The friability is expressed as the
loss of mass and it is calculated as a percentage of the initial mass.
Weight Variation Test
Weigh 20 tablets selected at random and calculate the average weight. Not
more than two of the individual weights deviate from the average weight by more than the
percentage shown in table 10 and none deviates by more than twice that percentage.
Average weight of tablet Percentage deviation
130 mg or less
More than 130 mg but less than 324 mg
324 mg or more
10
7.5
5
Table : IP Standards for percentage weight variation
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Disintegration Time
The disintegration time for all formulations was carried out using
LABINDIA tablet disintegration test apparatus. Six tablets were placed individually in each tube
of disintegration test apparatus. The water was maintained at a temperature of 372C and time
taken for the entire tablet to disintegrate completely was noted.
Drug Release Studies
In vitro drug release studies were carried out by using LABINDIA
Dissolution Test Apparatus DS8000 using paddle stirrer at rotation speed of 50 rpm. The drug
release profile from tablets (n=3) of each formulation was studied in 900 ml of distilled water
maintained at 37 0.5C. Aliquots of 5 ml of dissolution medium were withdrawn at specific
time intervals (5, 10, 15, 20, 25,30,40,50 and 60 minutes), filtered and the amount of drug in the
samples was estimated using UV-Visibile spectrophotometer at wave length of 240nm and
results were reported.