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Presented By: DHRUTI AVLANI
Roll No.: 27720316018
Reg No.: 162772310024
M.Pharm, 2nd
Year, 4th
Semester
NSHM Knowledge Campus, Kolkata – Group of Institutions
GUIDE: Dr. Sutapa Biswas Majee
SL. NO. TITLE OF WORK OUTCOME REF.
1 Evaluation of Ocimum
sanctum and Ocimum
basillicum mucilage-
As a pharmaceutical
excipient.
The extracted mucilages from the seed of
Ocimum sanctum and Ocimum basillicum were
evaluated for physicochemical properties, water
absorption capacity, phytochemical test etc.
3
2 Evaluation of binding
properties of Plantago
psyllium seed mucilage
The suitability of psyllium mucilage for a
pharmaceutical binder was assessed in
paracetamol tablets. Psyllium mucilage at 5 %
(m/m) was found to be comparable with 3 %
(m/m) of PVP. Investigated paracetamol tablets
indicated that psyllium mucilage can retard the
drug release.
4
3 Effect of sugar and
salts on rheological
properties of Balangu
seed gum
Synergistic interaction between Balangu seed
gum (BSG, 1% w/w) gum and sugars improved
the viscosity of solutions, whereas addition of
salts decreased viscosity of gum solutions. Power
law model well described non-Newtonian
pseudoplastic behaviour of BSG. Addition of
sucrose, fructose, lactose and salts to BSG led to
more pseudoplastic solutions, whereas glucose
decreased pseudoplasticity of solutions.
5
SL.
NO.
TITLE OF
WORK
OUTCOME REF.
4 Chia seeds:
microstructure,
mucilage
extraction and
hydration
The study reported the effect of temperature, pH and seed :
water ratio on extraction of the mucilage of chia seeds and the
effect of temperature, pH and ionic strength on hydration of the
extracted mucilage. During extraction, temperature and seed :
water ratio were found to have a significant effect on yield.
Hydration of the extracted mucilage was significantly increased
at high pH values, and was higher when salt concentration
decreased, being maximal when the temperature reached values
close to 80°C.
6
5 Isolation and
evaluation of
fenugreek ,
flaxseed
mucilages and
its use as a
pharmaceutical
binder
Fenugreek seeds (FNM) and flax seeds (FXM) produce high
viscosity mucilage at low concentration levels. The binding
properties of the mucilage isolated were investigated using
lactose granules with different binder concentrations levels of
3%w/v, 5% w/v, 7% w/v and 10% w/v. The results were
compared with regularly used binders such as starch paste, PVP
and 1:1 concentration of both FXM and FNM. The Physical
properties of the granules and tablets were assessed. Tablets at
7 % w/v binder concentration showed good results as compared
to starch, PVP and 1:1 of 7% w/v total FXM and FNM. The
comparative results showed good tableting properties revealing
the use of natural polysaccharide based binders for preparation
of uncoated tablet dosage form.
7
Benzalkonium chloride, Calcium chloride, Dextrose, Di-calcium phosphate, Di-potassium hydrogen
phosphate, Di-sodium hydrogen phosphate, Glycerin, Hydrochloric acid, Hydroxypropyl methyl
cellulose (HPMC K15M), Lactose, Magnesium stearate, Mannitol, Methyl paraben, Microcrystalline
cellulose, Paracetamol, Potassium dihydrogen phosphate, Propyl paraben, Propylene Glycol, Sodium
chloride, Sodium hydroxide pellets, Sorbitol, Starch, Sucrose, Talc, Tween 80, Urea
Analytical Balance, Centrifuge, Compound Microscope, Disintegration Apparatus, Dissolution
Apparatus, Double Distillation Apparatus, Friabilator, FTIR, Hardness Tester, Hot Air Oven, Hot
Plate, HPTLC, Magnetic Stirrer with Thermostat, Mechanical Stirrer, Melting Point Apparatus, pH
Meter, Polarimeter, Refractometer, Refrigerator, Table Machine, Tray Dryer, UV-VIS
Spectropotometer, Vertical Autoclave, Water Bath, XRD
The plant specimen was authenticated as Ocimum basilicum L. by Central
National Herbarium, Botanical Survey of India, Shibpur, Howrah
2-2.5 mm
1.2-1.5 mm
0.8-1.0 mm
Fig 1: Whole seed
Fig 3: Transverse section of whole seed
Seed Coat
Kernel
Fig 4: Transverse section of swollen seed
Trichomes
Fig 2: Onset of
swelling
Shape
: Small, oval and
flattened
Colour : Dark brown to black
Odour : Odourless
Taste : Tasteless
Geometric
diameter
: 1.24 ± 0.31 mm
Sphericity : 0.62 ± 0.01
Surface
area
: 4.83 ± 0.5 mm2
Strained
through
muslin
cloth
Weighing of whole
chia seeds
Seed : Solvent = 1:50 Continuous stirring at 1200
rpm at 60°C for 3 h
Weighing of dried
mucilage film
Extracted mucilage
spread as a thin film
Thick mucilage
formation
Onset of
swelling
Overnight
drying at
50° C
Mucilage film stored in desiccator at 25°C for future use  YIELD: 20-25%
Powdered mucilage : Off white colour, flaky appearance, odourless & tasteless
# All data reported are average
of 3 readings taken under
identical experimental condition
+ For rheological study, Na-
CMC at respective
concentration has been used as
control
* Mucilage hydrated for 1 hour
in appropriate medium in room
temperature prior to study
++ For swelling study, Psyllium
at respective concentration has
been used as control
Decomposes at 230°CDecomposes at 230°C
The mucilage contains
–OH group with
intermolecular
hydrogen bonding as in
polysaccharides, with
1→4 glycosidic bonds.
This indicates that
chemically mucilage
belongs to the class of
carbohydrate
The mucilage contains
–OH group with
intermolecular
hydrogen bonding as in
polysaccharides, with
1→4 glycosidic bonds.
This indicates that
chemically mucilage
belongs to the class of
carbohydrate
Qualitative phytochemical screening of Ocimum
basilicum L. seed mucilage revealed the presence of
non-reducing sugars, gums and mucilage.
Qualitative phytochemical screening of Ocimum
basilicum L. seed mucilage revealed the presence of
non-reducing sugars, gums and mucilage.
Fig 5: FTIR of dry powdered mucilage
 BSM has a great capacity of hydration since it can absorb water 84 times its own
weight.
 Swelling is maximum at pH 7.0 and reaches a minimum value at pH 8.0.
 Interpretation of swelling kinetics data revealed that second order kinetics was
followed in all the pHs with r2
values varying from 0.975 in pH 7.4 to 0.999 in pH 1.2.
 BSM has a great capacity of hydration since it can absorb water 84 times its own
weight.
 Swelling is maximum at pH 7.0 and reaches a minimum value at pH 8.0.
 Interpretation of swelling kinetics data revealed that second order kinetics was
followed in all the pHs with r2
values varying from 0.975 in pH 7.4 to 0.999 in pH 1.2.
MEDIA
SWELLING
INDEX
SWELLING
KINETICS
POWER
LAW
SECOND
ORDER
R2
R2
pH 1.2 350 0.993 0.999
pH 5.5 300 0.960 0.997
pH 6.0 200 0.949 0.978
pH 6.0
(NM)
462 0.932 0.969
pH 6.8 440 0.912 0.997
WATER 950 0.975 0.982
pH 7.4 325 0.939 0.975
pH 8.0 150 0.921 0.998
Table 1 and Fig 6: Swelling index and kinetics
of 0.25% BSM in buffers of varying pH
 Relative viscosity (RV)
values of seed mucilage are
lower than those of control.
 BSM is not stable to
autoclaving
 Not recommended for the
purpose of ophthalmic and
parenteral preparation
intended for terminal
sterilisation by autoclaving.
 Relative viscosity (RV)
values of seed mucilage are
lower than those of control.
 BSM is not stable to
autoclaving
 Not recommended for the
purpose of ophthalmic and
parenteral preparation
intended for terminal
sterilisation by autoclaving.
Temp: 31°C
Fig 7: Effect of autoclaving on relative viscosity
EFFECT OF
AUTOCLAVING
CONCENTRATION (%w/v)
RELATIVE VISCOSITY –
BSM
RELATIVE VISCOSITY -
CONTROL
BS AS BS AS
0.0625 1.24 1.02 3.56 3.45
0.125 1.91 1.68 5.31 5.17
0.25 4.15 4.07 8.95 8.75
For seed mucilage:
Water > pH 6.0 (NM) > pH 1.2 > pH 5.5 > pH 6.8 > pH 7.4 > pH 6.0 > pH 8.0
For control:
Water > pH 7.4 > pH 6.8 > pH 5.5 > pH 8.0 > pH 6.0 > pH 1.2
( In nasal medium dispersion not possible )
EFFECT OF pH
CONCENTR-
ATION (%w/v)
RV - BSM
RV -
CONTROL
pH 1.2 2.45 1.23
pH 5.5 2.26 2.75
pH 6.0 1.86 2
pH 6.0 (NM) 2.94 -
pH 6.8 2.18 2.89
Water 3.20 4.65
pH 7.4 2.10 3.58
pH 8.0 1.80 2.18
EFFECT OF ADDITIVES
ADDITIVES RV OBSERVATION SIGNIFCANCE
NaCl 0 ↓↓↓
Cannot be used in ophthalmic and parenteral preparations as
isotonicity adjusting agents
Sorbitol 1.46 ↓ To be used with care in liquid preparations for diabetics
Propylene glycol 1.83 ↓ To be used with care as co-solvent in liquid dosage forms
Sucrose 1.96 ↓
Higher concentration may be required in syrup based
formulations using viscosity enhancing agents
CaCl2 1.02 ↓
To be used with care in liquid preparations and cannot be used
in development of sodium alginate-BSM microspheres by
ionotropic gelation methods
Mannitol 2.17 ↑↑ To be used with care in lyophilisable preparations
Dextrose 1.91 ↓
To be used with care in ophthalmic and parenteral preparations
as isotonicity adjusting agents
Tween 80 0 ↓↓↓ Cannot be used as surfactant in liquid preparations
Urea 1.91 ↓
Cannot be used as a gelling agent in preparations of urea gel
for topical delivery
Table 2: Compatibility profile of BSM with tested additives
0.25%w/v Mucilage : 4.07
# All data reported are average
of 3 readings taken under
identical experimental condition
 pH  Redispersibility
Flow rate  Sedimentaion volume
 pH  Percent drug content
 Spreadability  In vitro diffusion & permeation
 Extrudability  Drug diffusion kinetics
 Pre-compression
evaluation
 Cumulative percent
release
 Physical evaluation  Drug release kinetics
INGREDIENTS
COMPOSITION (%w/v)
PAEDIATRI
C
ADULT
Drug (PCM) 2.4 10
BSM 1 1
Methyl paraben 0.2 0.2
Propyl paraben 0.2 0.2
Tween 80 2-4 drops 2-4 drops
Glycerine 5 5
Water
qs to
30ml
qs to
30ml
Fig 8: Paediatric and adult PCM
suspensions
Basil seed mucilage (1%w/v) is an effective suspending agent for
paediatric and adult PCM suspensions
Basil seed mucilage (1%w/v) is an effective suspending agent for
paediatric and adult PCM suspensions
PROPERTIES OBSERVATIONS
pH 7.0 to 8.0
Sedimentation
volume
No settling of
particles
Flow rate 1.11 ± 0.05 ml/sec
Redispersibility Unaffected
Table 3: Composition of suspensions
Table 4: Suspension properties of BSM
Fig 9: BSM based nasal gel
Formu-
lation
No.
Concen-
tration
(%w/w)
Net
Content
(gm)
pH
Spreada-
bility
(g cm sec-1
)
Extrud-
ability
(cm)
Percent
Drug
Content
SSflux
(mg.cm2
.
min)
Kp
G1 6 30 6.0 1.50 7.5 99 14.902 14.902
G2 8 30 6.0 1.30 8 97 10.920 10.920
G3 10 30 6.0 1.26 9 95 12.398 12.398
G4 12 30 6.0 0.5 5 90 10.030 10.030
Table 5: Evaluation parameters for nasal gel formulation containing BSM as gelling agent
Standard curve of PCM in pH 6.0 (NM) at 243nm : y = 0.056x (r2
= 0.999)
Time
(h)
CPR
G1 G2 G3 G4
0.5 53.567 46.433 44.033 37.500
1.0 69.300 54.033 59.433 42.767
1.5 79.533 61.667 65.233 50.833
2.0 86.600 68.333 72.567 57.200
2.5 94.333 75.500 78.567 63.533 Fig 10: Cumulative percent release
of drug in nasal gel in 2.5 hs
Formu-
lation
No. CPR (%)in
2.5 hours
t 50
(h)
ZERO
ORDER
FIRST
ORDER
HIGUCHI
KORSMEYER-
PEPPAS
r2
r2
r2
r2
n
G1 94.3 < 0.5 0.970 0.935 0.995 0.998 0.348
G2 75.5 0.72 0.999 0.991 0.991 0.980 0.298
G3 78.5 0.68 0.956 0.914 0.986 0.990 0.351
G4 63.5 1.43 0.996 0.992 0.980 0.964 0.329
Table 6: In vitro diffusion profile and drug diffusion kinetics for nasal gel formulation
containing BSM as gelling agent
Basil seed mucilage is having a potential gelling property and it
can be used for the development of gel formulations
Basil seed mucilage is having a potential gelling property and it
can be used for the development of gel formulations
INGREDIENTS
COMPOSITION (%w/w)
T1 T2 T3 T4 T5 T6 T7 T8
Drug 10 10 10 10 10 10 10 10
Starch 40 - 20 10 30 20 10 30
HPMC - - 20 30 10 20 30 10
BSM - 40 - - - - - -
DCP 12 12 12 12 12 12 12 12
Lactose 35 35 35 35 35 35 35 35
Mg. stearate 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5
Talc 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5
FINAL TABLET
WEIGHT (mg)
120 120 120 120 120 120 120 120
Table 7: Composition of 8 batches of tablets by wet granulation technique
INGREDIENTS
FORMULATION
T1 T2 T3 T4 T5 T6 T7 T8
Compressibility (%) 27 19.3 20.7 19.8 21.3 22.2 22.8 22.5
Hausner’s Ratio 1.3 1.2 1.13 1.1 1.07 1.09 1.0 1.25
Angle of repose (°) 27.3 23.2 21.7 20.6 20.3 21.4 22.1 21.6
Table 8: Pre-compression evaluation parameters of granules with BSM as
binder
Standard curve of PCM in pH 1.2 at 243nm : y = 0.065x (r2
= 0.999)
Fig 11: Cumulative percent release of drug
from tablets
 Batch T7 containing BSM : HPMC in
the ratio of 1:3 released 99.14 % drug
in 4 h.
 Other BSM based batches (T6 and T8)
released 87.75 and 92.1% drug within
1.5 and 1 h respectively.
 Batch T7 containing BSM : HPMC in
the ratio of 1:3 released 99.14 % drug
in 4 h.
 Other BSM based batches (T6 and T8)
released 87.75 and 92.1% drug within
1.5 and 1 h respectively.
Time
(mins)
CPR
T2 T6 T7 T8
10 34.583 32.050 26.250 42.308
20 44.550 36.217 30.383 51.708
30 55.908 41.058 34.558 62.483
40 78.875 45.950 38.708 73.992
50 85.442 50.242 44.208 81.767
60 89.442 55.858 49.758 92.175
75 97.392 65.317 56.025 -
90 - 87.758 63.600 -
120 - - 78.958 -
150 - - 83.540 -
180 - - 89.458 -
210 - - 92.883 -
240 - - 99.500 -
Formu-
lation
No.
ZERO
ORDER
FIRST
ORDER
HIGUCHI KORSMEYER-PEPPAS
REMARKS
r2
r2
r2
r2
n
T1 NA NA NA NA NA - *
T2 0.935 0.893 0.942 0.991 0.310 - *
T3 0.976 0.947 0.967 0.914 0.366 - *
T4 0.978 0.938 0.966 0.904 0.423 - *
T5 0.988 0.955 0.972 0.925 0.376 - *
T6 0.938 0.988 0.865 0.874 0.417 - *
T7 0.954 0.882 0.985 0.974 0.442 Fickian
T8 0.998 0.982 0.940 0.993 0.320 - *
* indicates n values << 0.45
NA – Not applicable as disintegrated and dissolved completely within 10 minutes with CPR of 100%
Table 9: Drug release kinetics of tablet batches in pH 1.2 at 37°C
 For T7, the diffusion coefficient value was found to be 0.442, indicating drug diffusion out of
the matrix tablet via pure Fickian diffusion.
 Thus from the above studies T7 can be considered to be the best batch as matrix type
swellable GRDDS for sustained release since it can release the drug over a period of 4 hours in
pH 1.2 (gastric juice) and the dissolution process is diffusion-controlled.
Therefore, BSM in conjunction with HPMC K15M in suitable ratio can be used
in the development of dimensionally stable, swellable sustained release GRDDS.
 For T7, the diffusion coefficient value was found to be 0.442, indicating drug diffusion out of
the matrix tablet via pure Fickian diffusion.
 Thus from the above studies T7 can be considered to be the best batch as matrix type
swellable GRDDS for sustained release since it can release the drug over a period of 4 hours in
pH 1.2 (gastric juice) and the dissolution process is diffusion-controlled.
Therefore, BSM in conjunction with HPMC K15M in suitable ratio can be used
in the development of dimensionally stable, swellable sustained release GRDDS.
No change in organoleptic properties or pH of BSM aqueous
dispersions was detected in the pHs selected for stability
study.
Hence, BSM can be considered to be stable both in dry state
as well as dispersed state.
• FTIR study reveals that chemically the mucilage belongs to the class of
carbohydrate. Mucilages are carbohydrate based biopolymers which are hydrophilic
in nature, being able to attract and bind with a volume of water that far exceeds the
mass of the mucilage.
•BSM has a great capacity of hydration since it can absorb 84 times its own weight of
water.
•Swelling index and viscosity of BSM were found to be maximum in water. The
degree of swelling was appreciable in acidic pH.
•The role of pH in regulating water sorption of mucilageneous polymeric hydrogels is
of immense significance, as a change in pH of the swelling medium often results in a
fluctuation in free volumes accessible to penetrant water molecules, which in turn,
affects swelling characteristics of the mucilage.
•Swelling is an important characteristic of polymer that controls the drug release and
increases the retention of the GRDDS using BSM as an excipient.
Thus, mucilage of basil seed can be employed as a potential ingredient in
suspensions, emulsions, gels and tablets especially as viscosity enhancing agents,
thickening agent, emulsifier or gelling agent and release retardant because of its
good hydrophilic nature, physical stability, barrier properties, efficient control of
release profile, extrudability and good spreadability.
Extensive characterisation of natural polymer in dosage form development
for subsequent commercialisation has given rise to a new term
“Naturapolyceutics”
 Evaluation of disintegrant activity of BSM at higher concentration
Evaluation of BSM as polymer for development of sustained release
microspheres.
 Evaluation of effect of lyophilisation on performance of BSM.
 In vivo/ Ex vivo studies to assess toxicity, irritation/ sensitisation
potential of BSM.
 Stability study as per ICH guidelines.
 As it is purchased from the local market, it might be adulterated or
substituted with a spurious substance. So, it is better to start harvesting
under controlled conditions and proceed for mucilage extraction for
commercial purpose.
1. Jania G, Shah D, Prajapatia V, Jain V (2009). Gums and mucilages: Versatile
excipients for pharmaceutical formulations. Asian J. Pharm. Sci. 4(5):308-322.
http://dx.doi.org/10.1.1.472.4557
2. Chowdhury M, Sengupta A, Datta L, Chatterjee S (2017). Role of mucilage as
pharmaceutical additives and cytoprotective agent. J. Innov. Pharm. Biol. Sci. 4(2);46-
52.
3. Kadam PV, Yadav KN, Jagdale SK, Shivatare RS, Bhilwade SK, Patil MJ. Evaluation
of Ocimum sanctum and Ocimum basillicum mucilage- As a pharmaceutical excipient.
J Chem Pharm Res 2012; 4: 1950-5.
4. Saeedi M. Evaluation of binding properties of Plantago psyllium seed mucilage Acta
Pharm 2010; 60: 339–48.
5. Salehi F, Kashaninejad M, Behshad V. Effect of sugar and salts on rheological
properties of Balangu seed gum. Int J Biol Macromol 2014; 67: 16-21.
6. Munoz LA, Cobos A, Diaz O, et al. Chia seeds: microstructure, mucilage extraction
and hydration. J Food Eng 108 2012; 216-24.
7. Inamdar M, Abhang P, Momin M. Isolation and evaluation of fenugreek , flaxseed
mucilages and its use as a pharmaceutical binder. Int J Pharm Tech 2012; 4: 4766-77.
8. Munoz L. Mucilage from chia seeds (Salvia hispanica): Microestructure, Physico-
chemical characterization and applications in food industry. [Thesis]. Pontificia
Universidad Catolica De Chile Escuela De Ingenieria 2012.
9. Timilsena YP, Adhikari R., Kasapis S, and Adhikari, B. Molecular and functional
characteristics of purified gum from Australian chia seeds. Carb Poly 2015.
10. Sankar R, Jain SK. Development and characterization of gastroretentive sustained-
release formulation by combination of swelling and mucoadhesive approach: a
mechanistic study. Drug Design Dev Ther 2013.
http://dx.doi.org/10.2147/DDDT.S52890
11. Farahnaky A, Aksari H, Majzoobi M et al. The impact on concentration, temperature
and pH on dynamic rheology of psyllium gels. J Food Eng 2010; 100: 294-301.
12. Deshmukh SS, Katare YS, Shyale SS et al. Isolation and evaluation of mucilage of
Adansonia digitata Linn as a suspending agent. J Pharm 2013: 1-4.
13. Basu S, Chakraborty A, Bandyopadhyay AK. Development and evaluation of a
mucoadhesive nasal gel of midazolam prepared with Linum usitatissimum L. seed
mucilage. Scientia Pharmaceutica 2009; 77; 899–910.
14. Costa P, Lobo JMS. Modeling and comparison of dissolution profiles. Eur J Pharm Sci
2001;13: 123-33.
15. Indian Pharmacopoeia; Government of India, Ministry of Health and Family Welfare
Department; 7th
edition; 2014; 1: 187-94.
MATHEMATICAL MODELS USED TO DESCRIBE DRUG RELEASE/DIFFUSION MECHANISM
MODEL EQUATION
Zero order Qt = Q0 + k0t
First order lnQt = lnQ0 + k1t
Higuchi Qt = kH√t
Korsmeyer-Peppas Qt / Qα = kKtn
Where,
Qt – Cumulative amount (%) of drug substance (Q) released at the time t
Q0 – Initial value of Q
Qα – Maximum value of Q (assumed to be 100%)
t – Time (hrs)
k0, k1, kH, kK – appropriate rate constants i.e., zero order, first order, Higuchi and Korsmeyer-Peppas constants
respectively.
n – Drug release exponent in order to characterize drug diffusion mechanism whose values may range from 0.5 to 1.0
and in extreme cases may exceed 1.0 indicating different mechanisms of drug transport from polymeric drug delivery
system.INTERPREATION OF DISSOLUTION RELEASE MECHANISMS FROM POLYMERIC DEVICES
RELEASE EXPONENT
(n)
DRUG TRANSPORT RATE AS A
FUNCTION MECHANISM
RATE AS A FUNCTION OF TIME
0.45 Fickian Diffusion t-0.5
0.45 < n < 1.0 Anomalous transport tn-1
1.0 Case II transport Zero order release
Higher than 1.0 Super Case II Transport tn-1
Concentration (µg/ml)
Absorbance at
243 nm
0 0
2 0.143
4 0.268
6 0.395
8 0.526
10 0.675
12 0.793
14 0.903
Standard curve of PCM in pH 1.2 at 243nm
Standard curve of PCM in pH 6.0 (NM) at 243nm
Concentration
(µg/ml)
Absorbance at 243
nm
0 0
2 0.131
4 0.238
6 0.347
8 0.454
10 0.565
12 0.676
14 0.786
Table 27: Physical evaluation of tablets of all batches
PARAMETERS
FORMULATIONS
T1 T2 T3 T4 T5 T6 T7 T8
Thickness (mm)
(n=10)
3 ± 0.01 3 ± 0.03 3 ± 0.00 3 ± 0.01 3 ± 0.01 3 ± 0.02 3 ± 0.02 3 ± 0.03
Diameter (mm)
(n=10)
6 ± 0.01 6 ± 0.00 6 ± 0.00 6 ± 0.01 6 ± 0.02 6 ± 0.012 6 ± 0.02 6 ± 0.00
% Weight Variation
(n=20)
1.816 ±
0.087
2.153 ±
0.055
1.714 ±
0.080
1.333 ±
0.152
2.133 ±
0.152
1.426 ±
0.060
1.709 ±
0.015
1.820 ±
0.010
Hardness (kg/cm2
)
(n=10)
2.167 ±
0.115
4.366 ±
0.230
2.6 ± 0.1 3.375 ±
0.115
2.57 ±
0.115
3.36 ±
0.152
2.23 ±
0.110
3.19 ±
0.216
% Friability (n=6) 0.39 ±
0.08
0.32 ±
0.087
0.44 ±
0.06
0.43 ±
0.057
0.32 ±
0.068
0.37 ±
0.032
0.33 ±
0.064
0.32 ±
0.082
Drug Content (%)
(n=6)
97.96 ±
2.6
93.11 ±
7.17
98.32 ±
2.78
100 ±
6.245
95.53 ±
3.139
94.93 ±
4.9
96.78 ±
6.33
95.51 ±
4.64
Maximum Swelling
Index (%)(n=6)
0 330 ± 5.32 90 ± 4.30 96 ± 2.23 109 ± 4.35 445 ± 4.32 463 ± 4.17 310 ± 5.2
Dimensional
stability (hrs) (n=6)
0.08 ±
0.12
15.22 ±
0.81
1.56 ±
1.92
2.50 ±
0.62
1.92 ±
1.23
3.44 ±
0.58
9.8 ± 1.64 11.42 ±
0.91

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Dhruti Avlani - Basil Seed Mucilage

  • 1. Presented By: DHRUTI AVLANI Roll No.: 27720316018 Reg No.: 162772310024 M.Pharm, 2nd Year, 4th Semester NSHM Knowledge Campus, Kolkata – Group of Institutions GUIDE: Dr. Sutapa Biswas Majee
  • 2.
  • 3. SL. NO. TITLE OF WORK OUTCOME REF. 1 Evaluation of Ocimum sanctum and Ocimum basillicum mucilage- As a pharmaceutical excipient. The extracted mucilages from the seed of Ocimum sanctum and Ocimum basillicum were evaluated for physicochemical properties, water absorption capacity, phytochemical test etc. 3 2 Evaluation of binding properties of Plantago psyllium seed mucilage The suitability of psyllium mucilage for a pharmaceutical binder was assessed in paracetamol tablets. Psyllium mucilage at 5 % (m/m) was found to be comparable with 3 % (m/m) of PVP. Investigated paracetamol tablets indicated that psyllium mucilage can retard the drug release. 4 3 Effect of sugar and salts on rheological properties of Balangu seed gum Synergistic interaction between Balangu seed gum (BSG, 1% w/w) gum and sugars improved the viscosity of solutions, whereas addition of salts decreased viscosity of gum solutions. Power law model well described non-Newtonian pseudoplastic behaviour of BSG. Addition of sucrose, fructose, lactose and salts to BSG led to more pseudoplastic solutions, whereas glucose decreased pseudoplasticity of solutions. 5
  • 4. SL. NO. TITLE OF WORK OUTCOME REF. 4 Chia seeds: microstructure, mucilage extraction and hydration The study reported the effect of temperature, pH and seed : water ratio on extraction of the mucilage of chia seeds and the effect of temperature, pH and ionic strength on hydration of the extracted mucilage. During extraction, temperature and seed : water ratio were found to have a significant effect on yield. Hydration of the extracted mucilage was significantly increased at high pH values, and was higher when salt concentration decreased, being maximal when the temperature reached values close to 80°C. 6 5 Isolation and evaluation of fenugreek , flaxseed mucilages and its use as a pharmaceutical binder Fenugreek seeds (FNM) and flax seeds (FXM) produce high viscosity mucilage at low concentration levels. The binding properties of the mucilage isolated were investigated using lactose granules with different binder concentrations levels of 3%w/v, 5% w/v, 7% w/v and 10% w/v. The results were compared with regularly used binders such as starch paste, PVP and 1:1 concentration of both FXM and FNM. The Physical properties of the granules and tablets were assessed. Tablets at 7 % w/v binder concentration showed good results as compared to starch, PVP and 1:1 of 7% w/v total FXM and FNM. The comparative results showed good tableting properties revealing the use of natural polysaccharide based binders for preparation of uncoated tablet dosage form. 7
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  • 6. Benzalkonium chloride, Calcium chloride, Dextrose, Di-calcium phosphate, Di-potassium hydrogen phosphate, Di-sodium hydrogen phosphate, Glycerin, Hydrochloric acid, Hydroxypropyl methyl cellulose (HPMC K15M), Lactose, Magnesium stearate, Mannitol, Methyl paraben, Microcrystalline cellulose, Paracetamol, Potassium dihydrogen phosphate, Propyl paraben, Propylene Glycol, Sodium chloride, Sodium hydroxide pellets, Sorbitol, Starch, Sucrose, Talc, Tween 80, Urea Analytical Balance, Centrifuge, Compound Microscope, Disintegration Apparatus, Dissolution Apparatus, Double Distillation Apparatus, Friabilator, FTIR, Hardness Tester, Hot Air Oven, Hot Plate, HPTLC, Magnetic Stirrer with Thermostat, Mechanical Stirrer, Melting Point Apparatus, pH Meter, Polarimeter, Refractometer, Refrigerator, Table Machine, Tray Dryer, UV-VIS Spectropotometer, Vertical Autoclave, Water Bath, XRD
  • 7. The plant specimen was authenticated as Ocimum basilicum L. by Central National Herbarium, Botanical Survey of India, Shibpur, Howrah
  • 8. 2-2.5 mm 1.2-1.5 mm 0.8-1.0 mm Fig 1: Whole seed Fig 3: Transverse section of whole seed Seed Coat Kernel Fig 4: Transverse section of swollen seed Trichomes Fig 2: Onset of swelling Shape : Small, oval and flattened Colour : Dark brown to black Odour : Odourless Taste : Tasteless Geometric diameter : 1.24 ± 0.31 mm Sphericity : 0.62 ± 0.01 Surface area : 4.83 ± 0.5 mm2
  • 9. Strained through muslin cloth Weighing of whole chia seeds Seed : Solvent = 1:50 Continuous stirring at 1200 rpm at 60°C for 3 h Weighing of dried mucilage film Extracted mucilage spread as a thin film Thick mucilage formation Onset of swelling Overnight drying at 50° C Mucilage film stored in desiccator at 25°C for future use  YIELD: 20-25% Powdered mucilage : Off white colour, flaky appearance, odourless & tasteless
  • 10. # All data reported are average of 3 readings taken under identical experimental condition + For rheological study, Na- CMC at respective concentration has been used as control * Mucilage hydrated for 1 hour in appropriate medium in room temperature prior to study ++ For swelling study, Psyllium at respective concentration has been used as control
  • 11. Decomposes at 230°CDecomposes at 230°C The mucilage contains –OH group with intermolecular hydrogen bonding as in polysaccharides, with 1→4 glycosidic bonds. This indicates that chemically mucilage belongs to the class of carbohydrate The mucilage contains –OH group with intermolecular hydrogen bonding as in polysaccharides, with 1→4 glycosidic bonds. This indicates that chemically mucilage belongs to the class of carbohydrate Qualitative phytochemical screening of Ocimum basilicum L. seed mucilage revealed the presence of non-reducing sugars, gums and mucilage. Qualitative phytochemical screening of Ocimum basilicum L. seed mucilage revealed the presence of non-reducing sugars, gums and mucilage. Fig 5: FTIR of dry powdered mucilage
  • 12.  BSM has a great capacity of hydration since it can absorb water 84 times its own weight.  Swelling is maximum at pH 7.0 and reaches a minimum value at pH 8.0.  Interpretation of swelling kinetics data revealed that second order kinetics was followed in all the pHs with r2 values varying from 0.975 in pH 7.4 to 0.999 in pH 1.2.  BSM has a great capacity of hydration since it can absorb water 84 times its own weight.  Swelling is maximum at pH 7.0 and reaches a minimum value at pH 8.0.  Interpretation of swelling kinetics data revealed that second order kinetics was followed in all the pHs with r2 values varying from 0.975 in pH 7.4 to 0.999 in pH 1.2. MEDIA SWELLING INDEX SWELLING KINETICS POWER LAW SECOND ORDER R2 R2 pH 1.2 350 0.993 0.999 pH 5.5 300 0.960 0.997 pH 6.0 200 0.949 0.978 pH 6.0 (NM) 462 0.932 0.969 pH 6.8 440 0.912 0.997 WATER 950 0.975 0.982 pH 7.4 325 0.939 0.975 pH 8.0 150 0.921 0.998 Table 1 and Fig 6: Swelling index and kinetics of 0.25% BSM in buffers of varying pH
  • 13.  Relative viscosity (RV) values of seed mucilage are lower than those of control.  BSM is not stable to autoclaving  Not recommended for the purpose of ophthalmic and parenteral preparation intended for terminal sterilisation by autoclaving.  Relative viscosity (RV) values of seed mucilage are lower than those of control.  BSM is not stable to autoclaving  Not recommended for the purpose of ophthalmic and parenteral preparation intended for terminal sterilisation by autoclaving. Temp: 31°C Fig 7: Effect of autoclaving on relative viscosity EFFECT OF AUTOCLAVING CONCENTRATION (%w/v) RELATIVE VISCOSITY – BSM RELATIVE VISCOSITY - CONTROL BS AS BS AS 0.0625 1.24 1.02 3.56 3.45 0.125 1.91 1.68 5.31 5.17 0.25 4.15 4.07 8.95 8.75
  • 14. For seed mucilage: Water > pH 6.0 (NM) > pH 1.2 > pH 5.5 > pH 6.8 > pH 7.4 > pH 6.0 > pH 8.0 For control: Water > pH 7.4 > pH 6.8 > pH 5.5 > pH 8.0 > pH 6.0 > pH 1.2 ( In nasal medium dispersion not possible ) EFFECT OF pH CONCENTR- ATION (%w/v) RV - BSM RV - CONTROL pH 1.2 2.45 1.23 pH 5.5 2.26 2.75 pH 6.0 1.86 2 pH 6.0 (NM) 2.94 - pH 6.8 2.18 2.89 Water 3.20 4.65 pH 7.4 2.10 3.58 pH 8.0 1.80 2.18
  • 15. EFFECT OF ADDITIVES ADDITIVES RV OBSERVATION SIGNIFCANCE NaCl 0 ↓↓↓ Cannot be used in ophthalmic and parenteral preparations as isotonicity adjusting agents Sorbitol 1.46 ↓ To be used with care in liquid preparations for diabetics Propylene glycol 1.83 ↓ To be used with care as co-solvent in liquid dosage forms Sucrose 1.96 ↓ Higher concentration may be required in syrup based formulations using viscosity enhancing agents CaCl2 1.02 ↓ To be used with care in liquid preparations and cannot be used in development of sodium alginate-BSM microspheres by ionotropic gelation methods Mannitol 2.17 ↑↑ To be used with care in lyophilisable preparations Dextrose 1.91 ↓ To be used with care in ophthalmic and parenteral preparations as isotonicity adjusting agents Tween 80 0 ↓↓↓ Cannot be used as surfactant in liquid preparations Urea 1.91 ↓ Cannot be used as a gelling agent in preparations of urea gel for topical delivery Table 2: Compatibility profile of BSM with tested additives 0.25%w/v Mucilage : 4.07
  • 16. # All data reported are average of 3 readings taken under identical experimental condition  pH  Redispersibility Flow rate  Sedimentaion volume  pH  Percent drug content  Spreadability  In vitro diffusion & permeation  Extrudability  Drug diffusion kinetics  Pre-compression evaluation  Cumulative percent release  Physical evaluation  Drug release kinetics
  • 17. INGREDIENTS COMPOSITION (%w/v) PAEDIATRI C ADULT Drug (PCM) 2.4 10 BSM 1 1 Methyl paraben 0.2 0.2 Propyl paraben 0.2 0.2 Tween 80 2-4 drops 2-4 drops Glycerine 5 5 Water qs to 30ml qs to 30ml Fig 8: Paediatric and adult PCM suspensions Basil seed mucilage (1%w/v) is an effective suspending agent for paediatric and adult PCM suspensions Basil seed mucilage (1%w/v) is an effective suspending agent for paediatric and adult PCM suspensions PROPERTIES OBSERVATIONS pH 7.0 to 8.0 Sedimentation volume No settling of particles Flow rate 1.11 ± 0.05 ml/sec Redispersibility Unaffected Table 3: Composition of suspensions Table 4: Suspension properties of BSM
  • 18. Fig 9: BSM based nasal gel Formu- lation No. Concen- tration (%w/w) Net Content (gm) pH Spreada- bility (g cm sec-1 ) Extrud- ability (cm) Percent Drug Content SSflux (mg.cm2 . min) Kp G1 6 30 6.0 1.50 7.5 99 14.902 14.902 G2 8 30 6.0 1.30 8 97 10.920 10.920 G3 10 30 6.0 1.26 9 95 12.398 12.398 G4 12 30 6.0 0.5 5 90 10.030 10.030 Table 5: Evaluation parameters for nasal gel formulation containing BSM as gelling agent
  • 19. Standard curve of PCM in pH 6.0 (NM) at 243nm : y = 0.056x (r2 = 0.999) Time (h) CPR G1 G2 G3 G4 0.5 53.567 46.433 44.033 37.500 1.0 69.300 54.033 59.433 42.767 1.5 79.533 61.667 65.233 50.833 2.0 86.600 68.333 72.567 57.200 2.5 94.333 75.500 78.567 63.533 Fig 10: Cumulative percent release of drug in nasal gel in 2.5 hs
  • 20. Formu- lation No. CPR (%)in 2.5 hours t 50 (h) ZERO ORDER FIRST ORDER HIGUCHI KORSMEYER- PEPPAS r2 r2 r2 r2 n G1 94.3 < 0.5 0.970 0.935 0.995 0.998 0.348 G2 75.5 0.72 0.999 0.991 0.991 0.980 0.298 G3 78.5 0.68 0.956 0.914 0.986 0.990 0.351 G4 63.5 1.43 0.996 0.992 0.980 0.964 0.329 Table 6: In vitro diffusion profile and drug diffusion kinetics for nasal gel formulation containing BSM as gelling agent Basil seed mucilage is having a potential gelling property and it can be used for the development of gel formulations Basil seed mucilage is having a potential gelling property and it can be used for the development of gel formulations
  • 21. INGREDIENTS COMPOSITION (%w/w) T1 T2 T3 T4 T5 T6 T7 T8 Drug 10 10 10 10 10 10 10 10 Starch 40 - 20 10 30 20 10 30 HPMC - - 20 30 10 20 30 10 BSM - 40 - - - - - - DCP 12 12 12 12 12 12 12 12 Lactose 35 35 35 35 35 35 35 35 Mg. stearate 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5 Talc 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5 FINAL TABLET WEIGHT (mg) 120 120 120 120 120 120 120 120 Table 7: Composition of 8 batches of tablets by wet granulation technique
  • 22. INGREDIENTS FORMULATION T1 T2 T3 T4 T5 T6 T7 T8 Compressibility (%) 27 19.3 20.7 19.8 21.3 22.2 22.8 22.5 Hausner’s Ratio 1.3 1.2 1.13 1.1 1.07 1.09 1.0 1.25 Angle of repose (°) 27.3 23.2 21.7 20.6 20.3 21.4 22.1 21.6 Table 8: Pre-compression evaluation parameters of granules with BSM as binder Standard curve of PCM in pH 1.2 at 243nm : y = 0.065x (r2 = 0.999)
  • 23. Fig 11: Cumulative percent release of drug from tablets  Batch T7 containing BSM : HPMC in the ratio of 1:3 released 99.14 % drug in 4 h.  Other BSM based batches (T6 and T8) released 87.75 and 92.1% drug within 1.5 and 1 h respectively.  Batch T7 containing BSM : HPMC in the ratio of 1:3 released 99.14 % drug in 4 h.  Other BSM based batches (T6 and T8) released 87.75 and 92.1% drug within 1.5 and 1 h respectively. Time (mins) CPR T2 T6 T7 T8 10 34.583 32.050 26.250 42.308 20 44.550 36.217 30.383 51.708 30 55.908 41.058 34.558 62.483 40 78.875 45.950 38.708 73.992 50 85.442 50.242 44.208 81.767 60 89.442 55.858 49.758 92.175 75 97.392 65.317 56.025 - 90 - 87.758 63.600 - 120 - - 78.958 - 150 - - 83.540 - 180 - - 89.458 - 210 - - 92.883 - 240 - - 99.500 -
  • 24. Formu- lation No. ZERO ORDER FIRST ORDER HIGUCHI KORSMEYER-PEPPAS REMARKS r2 r2 r2 r2 n T1 NA NA NA NA NA - * T2 0.935 0.893 0.942 0.991 0.310 - * T3 0.976 0.947 0.967 0.914 0.366 - * T4 0.978 0.938 0.966 0.904 0.423 - * T5 0.988 0.955 0.972 0.925 0.376 - * T6 0.938 0.988 0.865 0.874 0.417 - * T7 0.954 0.882 0.985 0.974 0.442 Fickian T8 0.998 0.982 0.940 0.993 0.320 - * * indicates n values << 0.45 NA – Not applicable as disintegrated and dissolved completely within 10 minutes with CPR of 100% Table 9: Drug release kinetics of tablet batches in pH 1.2 at 37°C  For T7, the diffusion coefficient value was found to be 0.442, indicating drug diffusion out of the matrix tablet via pure Fickian diffusion.  Thus from the above studies T7 can be considered to be the best batch as matrix type swellable GRDDS for sustained release since it can release the drug over a period of 4 hours in pH 1.2 (gastric juice) and the dissolution process is diffusion-controlled. Therefore, BSM in conjunction with HPMC K15M in suitable ratio can be used in the development of dimensionally stable, swellable sustained release GRDDS.  For T7, the diffusion coefficient value was found to be 0.442, indicating drug diffusion out of the matrix tablet via pure Fickian diffusion.  Thus from the above studies T7 can be considered to be the best batch as matrix type swellable GRDDS for sustained release since it can release the drug over a period of 4 hours in pH 1.2 (gastric juice) and the dissolution process is diffusion-controlled. Therefore, BSM in conjunction with HPMC K15M in suitable ratio can be used in the development of dimensionally stable, swellable sustained release GRDDS.
  • 25. No change in organoleptic properties or pH of BSM aqueous dispersions was detected in the pHs selected for stability study. Hence, BSM can be considered to be stable both in dry state as well as dispersed state.
  • 26. • FTIR study reveals that chemically the mucilage belongs to the class of carbohydrate. Mucilages are carbohydrate based biopolymers which are hydrophilic in nature, being able to attract and bind with a volume of water that far exceeds the mass of the mucilage. •BSM has a great capacity of hydration since it can absorb 84 times its own weight of water. •Swelling index and viscosity of BSM were found to be maximum in water. The degree of swelling was appreciable in acidic pH. •The role of pH in regulating water sorption of mucilageneous polymeric hydrogels is of immense significance, as a change in pH of the swelling medium often results in a fluctuation in free volumes accessible to penetrant water molecules, which in turn, affects swelling characteristics of the mucilage. •Swelling is an important characteristic of polymer that controls the drug release and increases the retention of the GRDDS using BSM as an excipient.
  • 27. Thus, mucilage of basil seed can be employed as a potential ingredient in suspensions, emulsions, gels and tablets especially as viscosity enhancing agents, thickening agent, emulsifier or gelling agent and release retardant because of its good hydrophilic nature, physical stability, barrier properties, efficient control of release profile, extrudability and good spreadability. Extensive characterisation of natural polymer in dosage form development for subsequent commercialisation has given rise to a new term “Naturapolyceutics”
  • 28.  Evaluation of disintegrant activity of BSM at higher concentration Evaluation of BSM as polymer for development of sustained release microspheres.  Evaluation of effect of lyophilisation on performance of BSM.  In vivo/ Ex vivo studies to assess toxicity, irritation/ sensitisation potential of BSM.  Stability study as per ICH guidelines.  As it is purchased from the local market, it might be adulterated or substituted with a spurious substance. So, it is better to start harvesting under controlled conditions and proceed for mucilage extraction for commercial purpose.
  • 29. 1. Jania G, Shah D, Prajapatia V, Jain V (2009). Gums and mucilages: Versatile excipients for pharmaceutical formulations. Asian J. Pharm. Sci. 4(5):308-322. http://dx.doi.org/10.1.1.472.4557 2. Chowdhury M, Sengupta A, Datta L, Chatterjee S (2017). Role of mucilage as pharmaceutical additives and cytoprotective agent. J. Innov. Pharm. Biol. Sci. 4(2);46- 52. 3. Kadam PV, Yadav KN, Jagdale SK, Shivatare RS, Bhilwade SK, Patil MJ. Evaluation of Ocimum sanctum and Ocimum basillicum mucilage- As a pharmaceutical excipient. J Chem Pharm Res 2012; 4: 1950-5. 4. Saeedi M. Evaluation of binding properties of Plantago psyllium seed mucilage Acta Pharm 2010; 60: 339–48. 5. Salehi F, Kashaninejad M, Behshad V. Effect of sugar and salts on rheological properties of Balangu seed gum. Int J Biol Macromol 2014; 67: 16-21. 6. Munoz LA, Cobos A, Diaz O, et al. Chia seeds: microstructure, mucilage extraction and hydration. J Food Eng 108 2012; 216-24. 7. Inamdar M, Abhang P, Momin M. Isolation and evaluation of fenugreek , flaxseed mucilages and its use as a pharmaceutical binder. Int J Pharm Tech 2012; 4: 4766-77. 8. Munoz L. Mucilage from chia seeds (Salvia hispanica): Microestructure, Physico- chemical characterization and applications in food industry. [Thesis]. Pontificia Universidad Catolica De Chile Escuela De Ingenieria 2012.
  • 30. 9. Timilsena YP, Adhikari R., Kasapis S, and Adhikari, B. Molecular and functional characteristics of purified gum from Australian chia seeds. Carb Poly 2015. 10. Sankar R, Jain SK. Development and characterization of gastroretentive sustained- release formulation by combination of swelling and mucoadhesive approach: a mechanistic study. Drug Design Dev Ther 2013. http://dx.doi.org/10.2147/DDDT.S52890 11. Farahnaky A, Aksari H, Majzoobi M et al. The impact on concentration, temperature and pH on dynamic rheology of psyllium gels. J Food Eng 2010; 100: 294-301. 12. Deshmukh SS, Katare YS, Shyale SS et al. Isolation and evaluation of mucilage of Adansonia digitata Linn as a suspending agent. J Pharm 2013: 1-4. 13. Basu S, Chakraborty A, Bandyopadhyay AK. Development and evaluation of a mucoadhesive nasal gel of midazolam prepared with Linum usitatissimum L. seed mucilage. Scientia Pharmaceutica 2009; 77; 899–910. 14. Costa P, Lobo JMS. Modeling and comparison of dissolution profiles. Eur J Pharm Sci 2001;13: 123-33. 15. Indian Pharmacopoeia; Government of India, Ministry of Health and Family Welfare Department; 7th edition; 2014; 1: 187-94.
  • 31.
  • 32. MATHEMATICAL MODELS USED TO DESCRIBE DRUG RELEASE/DIFFUSION MECHANISM MODEL EQUATION Zero order Qt = Q0 + k0t First order lnQt = lnQ0 + k1t Higuchi Qt = kH√t Korsmeyer-Peppas Qt / Qα = kKtn Where, Qt – Cumulative amount (%) of drug substance (Q) released at the time t Q0 – Initial value of Q Qα – Maximum value of Q (assumed to be 100%) t – Time (hrs) k0, k1, kH, kK – appropriate rate constants i.e., zero order, first order, Higuchi and Korsmeyer-Peppas constants respectively. n – Drug release exponent in order to characterize drug diffusion mechanism whose values may range from 0.5 to 1.0 and in extreme cases may exceed 1.0 indicating different mechanisms of drug transport from polymeric drug delivery system.INTERPREATION OF DISSOLUTION RELEASE MECHANISMS FROM POLYMERIC DEVICES RELEASE EXPONENT (n) DRUG TRANSPORT RATE AS A FUNCTION MECHANISM RATE AS A FUNCTION OF TIME 0.45 Fickian Diffusion t-0.5 0.45 < n < 1.0 Anomalous transport tn-1 1.0 Case II transport Zero order release Higher than 1.0 Super Case II Transport tn-1
  • 33. Concentration (µg/ml) Absorbance at 243 nm 0 0 2 0.143 4 0.268 6 0.395 8 0.526 10 0.675 12 0.793 14 0.903 Standard curve of PCM in pH 1.2 at 243nm Standard curve of PCM in pH 6.0 (NM) at 243nm Concentration (µg/ml) Absorbance at 243 nm 0 0 2 0.131 4 0.238 6 0.347 8 0.454 10 0.565 12 0.676 14 0.786
  • 34. Table 27: Physical evaluation of tablets of all batches PARAMETERS FORMULATIONS T1 T2 T3 T4 T5 T6 T7 T8 Thickness (mm) (n=10) 3 ± 0.01 3 ± 0.03 3 ± 0.00 3 ± 0.01 3 ± 0.01 3 ± 0.02 3 ± 0.02 3 ± 0.03 Diameter (mm) (n=10) 6 ± 0.01 6 ± 0.00 6 ± 0.00 6 ± 0.01 6 ± 0.02 6 ± 0.012 6 ± 0.02 6 ± 0.00 % Weight Variation (n=20) 1.816 ± 0.087 2.153 ± 0.055 1.714 ± 0.080 1.333 ± 0.152 2.133 ± 0.152 1.426 ± 0.060 1.709 ± 0.015 1.820 ± 0.010 Hardness (kg/cm2 ) (n=10) 2.167 ± 0.115 4.366 ± 0.230 2.6 ± 0.1 3.375 ± 0.115 2.57 ± 0.115 3.36 ± 0.152 2.23 ± 0.110 3.19 ± 0.216 % Friability (n=6) 0.39 ± 0.08 0.32 ± 0.087 0.44 ± 0.06 0.43 ± 0.057 0.32 ± 0.068 0.37 ± 0.032 0.33 ± 0.064 0.32 ± 0.082 Drug Content (%) (n=6) 97.96 ± 2.6 93.11 ± 7.17 98.32 ± 2.78 100 ± 6.245 95.53 ± 3.139 94.93 ± 4.9 96.78 ± 6.33 95.51 ± 4.64 Maximum Swelling Index (%)(n=6) 0 330 ± 5.32 90 ± 4.30 96 ± 2.23 109 ± 4.35 445 ± 4.32 463 ± 4.17 310 ± 5.2 Dimensional stability (hrs) (n=6) 0.08 ± 0.12 15.22 ± 0.81 1.56 ± 1.92 2.50 ± 0.62 1.92 ± 1.23 3.44 ± 0.58 9.8 ± 1.64 11.42 ± 0.91