Journal of Research in Unani Medicine, Vol 4, Issue 1
Standard manufacturing procedure of Qurse Tabasheer - A herbo mineral Unani anti diabetic formulation Waris Ali, *Hamiduddin,AkhtarAli
Dept. of Ilmul Saidla (Unani pharmacy), National Institute of Unani Medicine (NIUM), Bangalore-91, Karnataka, India
*CorrespondingAuthor Email: drhamid2003@rediffmail.com Abstract
Background and Objectives: Qurs (Tablet) is one of the most suitable dosage forms due to its easy portability,
stability and accuracy of dose etc. Unani tablets contain diverse crude drugs which require specific manufacturing procedures for good quality of finished products to be maintained. In this work Qurse Tabasheer containing six ingredients, Tabasheer (Siliceous concretions) , Gule Surkh (Rosa damascena Mill. flower), Gulnar (Punica granatum Linn. flower), Tukhme kahu (Lactuca sativa Linn. seeds), Tukhme khurfa (Portulaca oleraceae Linn.
seeds ) and Gile Armani was taken up for study due to its important indication in diabetes, hummae hadda and diarrhea . Objective of this study was to develop standard operating procedure (SOP) for its manufacturing stages.
Materials and Methods: Total 18 batches were generated for the optimum working process related to the powder size, quantity of binder, granulation, temperature and duration for drying and compression on the basis of trial and error. All the batches were assessed for friability, hardness and disintegration time and final ideal batch was selected
on the basis of normal set parameters. Ideal working condition was documented as SOP for manufacturing procedure
and final ideal batch was again repeated to check the reproducibility. Result was analyzed by calculating mean ± SEM
(Standard error of mean).
Results: Friability (%), hardness (kg/cm) and disintegration time (Minutes) of selected final ideal batch and repeated final ideal batch was (0.0730±.01764, 0.09±0.0057), (4.10±.050, 4.03±0.087) and (26.16±0.5376, 25.57±0.4860) respectively and it was found within the set limit. Pre-compression parameters were fine, weight of tablet was 793.7 ± 4.755 mg and weight variation was <5%.
Conclusions: This work may be of utility in improving the quality when comparing parameters as it shows reproducible results. This SOP may be used for future reference for production of ideal Qurse Tabasheer quality wise. Key-words: Standard manufacturing procedure, Qurse Tabasheer, Unani, Tablets Introduction
compiled1. There has been an exponential growth in
in many countries of the world such as Chinese
origin and lesser adverse effects 2. Majority of the
The traditional system of medicine is being practiced
medicine (TCM), Indian system of medicine (ISM) (Ayurvedia, Unani and Sidha), African folklore etc.,
where the remedies are thoroughly documented and
herbal medicine in last few decades, due to natural
remedies of Indian system of medicine are based on plants / plant products and few on animal and mineral
products. In manufacturing process, a lot of variation
51
is being observed for preparation of same formulation from one company to another company, although they
start with similar raw materials . Process validation 1
and development of Standard Operating Procedures
(SOPs) of manufacturing procedure are very
necessary for Unani compound formulations, because the classical description of various operations for manufacturing procedure is not well defined in all
aspects as the principles developed relied on the
Journal of Research in Unani Medicine, Vol 4, Issue 1
preparation of Qurse Tabasheer was done for
achieving optimum friability, hardness disintegration
time and other quality specifications. This particular Qurse Tabasheer
formulation is mentioned in
Bayaaze Kabeer, Kitabul Murakkabat Al Maroof
Makhzanul Murakkabat and Kitab Al Murakkabat, it
is used in the treatment of Dhayabitus (Diabetes), Hummae Hadda (Acute fever) and Is'hal (Diarrhoea) . Hypoglycemic or antihyperglycemic and related
3, 4, 5, 6
extensive experience. Thus art of manufacturing
activities are reported in most of the individual
tablets are manufactured with contemporary
directly on Qurse Tabasheer 7, Qurse Tabasheer
contained visible elements of subjectivity. Nowadays technology, detail of which is not mention in classical
Unani text and different Unani tablets contain
different types of crude drugs which require specific and standard manufacturing procedures. Not following the specific and correct procedure for tablet
production will lead to poor quality tablet of very friable nature or extended disintegration time, and will
ultimately affect the efficacy and drug dosage compliance by the patient. All the above mentioned
issues are to be taken care of to get good quality of tablets and other Unani finished products which can
be safe and effective in various diseases for which
they are advocated. Hence the need of the hour is to conduct standardization of Unani formulations with respect to its manufacturing procedure i.e. SOPs
(quality), safety and efficacy validation and to reevaluate the standardization process in present global scenario.
Therefore in the present study standard operating procedure (SOP) of Qurse Tabasheer regarding various steps of its manufacturing process such as
particle size , quantity of binder, temperature of
drying, and duration of drying was developed, documentation of various process involve in the
ingredient of Qurse Tabasheer and their extracts, and extract showed antihyperglycemic, antihyperlipidemic activity in rats 8. Moreover this formulation was selected due to its important
indication i.e. in diabetes and to overcome the imperfect manufacturing procedure. Materials and Methods
Collection of Drugs / Ingredients and its identification: Gule Surkh (Rosa damascena Mill. flower), Gulnar (Punica granatum Linn. flower), Tukhme Kahu (Lactuca
sativa Linn. seeds) and
Tukhme Khurfa (Portulaca oleraceae Linn. seeds ) were procured from A.B. General Store, Avenue
Road; Bangalore and identified by expert at FRLHT (Foundation for Revitalization of Local Traditions)
Bangalore. Tabasheer (Siliceous concretions) was procured from a raw drug dealer 'Herbo World
Associates', New Delhi and identified by expert.
Different samples of Gile Armani were purchased from market and XRD was conducted at Department
of Material Engineering, Indian Institute of Sciences
Bangalore for its identification. The drug samples
were submitted in NIUM Drug Museum and voucher specimen No. was collected: 22/IS/Res/2014. [Table 1]
52
Journal of Research in Unani Medicine, Vol 4, Issue 1
Table1: Ingredients and excipients used in preparation of Qurse Tabasheer
Sr.No.
Ingredient / excipients
Role
1.
Tabasheer (Siliceous concretions)
Active drug
2.
Gule Surkh (Rosa damascena Mill.) Flower
Active drug
3.
Gulnar (Punica granatum Linn.) Flower
Active drug
4.
Gile Armani (Armenian bole)
Active drug
5.
Tukhme Kahu (Lactuca sativa Linn.) Seeds
Active drug
6.
Tukhme Khurfa (Portulaca oleraceaeLinn.) Seeds
Active drug
7.
Gum Acacia
Binder
8.
Water (filtered / R.O.)
For making Loab / lubdi
9.
Magnesium carbonate
Glidant
10.
Liquid paraffin
Lubricant
(wet massing)
Techniques used for process standardization: After
ingredients of Qurse Tabasheer: Tabasheer, Gule
were prepared. Different batch of tablets was
separately by using super mixer-grinder. Sieve no. 80,
identification of the ingredients, the Aqurs (Tablets)
generated by 120g powder in each batch for the optimum working process related to the powder size,
binder, granulation, temperature and time for drying and finally the compression of Qurs. Each batch was
assessed three times with the documentation of various steps of manufacturing process. The method mentioned in The Unani Pharmacopeia of India and National Formulary of Unani Medicine was followed for the preparation of Qurse Tabasheer with necessary modification
9, 10
.
Step1: Powdering and Sifting/Sieving of
Surkh, Gulnar and Gile Armani, were powdered
100 and 120 (B.S.S.) were used for Sieving of
powders. Powdering of Tukhme Kahu and Tukhme khurfa was done separately. Initially dry grinding was attempted and No. 80 mesh powder was obtained but
sieving through 100 and 120 no. mesh was not
possible so for attaining powder of these mesh size, wet grinding was done as mention in NFUM (National
formulary of Unani medicine) for powdering of tough,
hard and fibrous drug, instead of Sil-Batta, electrical Sil-Batta (wet grinder) was used 10.
Procedure of wet grinding: Tukhme Kahu was taken
53
and dried in sun for some time and then pound in iron
mortar, then the drug was put in wet grinder with water for 6 hr. (time in which finely grinded mass was
achieved) This wet finely grinded mass was then passed by the help of powder wiper through 100 no. mesh sieve, this mass was dried first in hot air oven at
up to 60°C for 2 hrs then dried in shade under the fan for 36 hrs. This dried mass was then put in mixergrinder for few minute; the powder obtained was
again passed through 100 no. mesh size. This sieved
powder was then preserved in air tight container for
further study. Similar procedure was followed for
obtaining powder of No. 120 mesh. Same procedure was followed for Tukhme Khurfa but after wet grinding and sieving, wet mass was dried for 32 hrs under fan.
Step 2: Preparation of binder solution: Three
binders, water, corn starch and gum acacia were initially tested for preparation of formulation but
finally on the basis of post-compression evaluation, gum acacia (I.P. grade) was selected for final study in different batches of Qurs Tabasheer. Binder S.A.
(Samaghe Arabi / Gum acacia) was taken in 10%,
15%, and 20% of the total w.t. of powder. Mucilage or
loab (binder solution / Loabe Samaghe Arabi) was prepared with binder: water (filtered / R.O.), 4: 6 w/w initially . 11
Step 3: Granulation:
Weighing of powdered drug and mixing: All six drugs powder were taken in equal quantity as mention
in the formulation and weighing of powdered drug is done by digital weighing machine. This separately
powdered and weighed drug was mixed properly in mixer grinder.
Journal of Research in Unani Medicine, Vol 4, Issue 1
Preparation of lubdi (Wet massing): Lubdi was
prepared by adding binder solution to previously mixed powder drug material with suitable amount of water and then this mass was put in mixer grinder for proper mixing of binder. Precaution was taken that
prepared lubdi should not be so hard and not so loose, till the damp mass / Snow ball was achieved.
Preparation of Granules / Screening: 16 no. mesh
sized granules were prepared of obtained material by using oscillating granulation machine, GMP model
(Cemach machinery Ltd., Ahmadabad SN. 1417). Size of the granulator screen (mesh size) was decided as per diameter of punches i.e. Tablet up to 7/32 to 5/16 inch in diameter = 16 mesh for granules 12.
Drying of granules: Prepared Granules were dried
for 30 minutes and 60 minutes at 60°C for all batches in hot air oven 13 (Labline Mod. No. HO 6, 7).
Inclusion of lubricant and glidant: 1% liquid paraffin as lubricant and 1% magnesium carbonates as
glidant of total wt. of powder were added slowly in dried granules, quantity of glidant and lubricant was selected on the basis of trial and error 14, 15.
Step 4: Compression: In this step blend of dried granules, lubricant and glidant were subjected to compression by multi-station rotary presses
(Tableting machine) GMP model (Cemach machinery Ltd. Mod. No. CM-D-20) at 6 Tone pressure for all batches, and calibrated to the weight of tablet approximately for 800 mg / tablet.
Step 5: Drying of tablets: Prepared tablets were dried
for 30 minutes at 60°C for all batches in drier (Tray
drier) (GMP model) (Pharmac, mod. No. 24) for removing additional moisture if any, and are then kept in air tight container. [Figure 1]
54
Journal of Research in Unani Medicine, Vol 4, Issue 1
Fig ure 1: Schematic pres entation of
manufacturing process Tablets obtained from different batches as mention above were evaluated for parameters such as friability, hardness and disintegration time. Total 18 batches were prepared for trial and error on the basis of different powder size i.e. 80,100 and 120 no. mesh
size, binder Samaghe Arabi concentration 10%, 15% and 20%, duration for drying of granules i.e. 30 minutes and 60 minutes at 60°C temperature and postcompression drying 30 minutes at 60°C was done for all batches, for preparation of SOP of manufacturing process of Qurs Tabahseer, one final (ideal) batch was selected on the basis of parameter mentioned above from the 18 batches. [Table 2
Table 2: Description of Batches of Qurse tabasheer prepared
Batch No.
Sieve No.
Particle
Binder
Temperature
Duration
Post-
Compression
( µm )
(%)
granules
drying
drying at
tons
size
S.A.
of drying of (°C)
of of
granules
compression 60°C
pressure in
1.
80
177
10%
60 °C
30 min
30 min
6
3.
80
177
15%
60 °C
30 min
30 min
6
2. 4. 5. 6.
80 80 80 80
177 177 177 177
10% 15% 20% 20%
60 °C 60 °C 60 °C 60 °C
60 min 60 min 30 min 60 min
30 min 30 min 30 min 30 min
6 6 6 6
55
7.
100
150
10%
60 °C
9.
100
150
15%
60 °C
8.
100
10.
100
12.
100
11.
13. 14. 15. 16. 17. 18.
150 150
100
150 150
120
125
120
125
120
125
120
125
120
125
120
125
10%
60 °C
15%
60 °C
20%
60 °C
20%
60 °C
10%
60 °C
10%
60 °C
15%
60 °C
15%
60 °C
20%
60 °C
20%
60 °C
Journal of Research in Unani Medicine, Vol 4, Issue 1
30 min
30 min
6
30 min
30 min
6
60 min 60 min 30 min 60 min 30 min 60 min 30 min 60 min 30 min 60 min
30 min 30 min 30 min 30 min 30 min 30 min 30 min 30 min 30 min 30 min
6 6 6 6 6 6 6 6 6 6
Pre-compression parameter: Final selected batch
than 0.5 to 1% of their weight are generally considered
parameter Bulk density, Tapped density,
formula: F = (W1¯W2/ W1) ×100
granules were also subjected to pre-compressions Compressibility index, Hausner's ratio,
[2,16,
Angle of repose.
[2, 17, 18]
18]
[16]
and
Techniques used for Process Standardization (Selection of ideal batch):
1. Friability test: Friability test apparatus Roche´s friabilator (Labinda mod. no. 1020) was used for
determination of friability of tablet. This device subject the tablet to the combined effect of abrasion and shock in a public chamber revolving at 25 rpm and dropping the tablets at a height of 6 inches in each
revolution. Tablets was placed in friabilator after weighing and subjected for 100 revolutions. Tablet
de-dusted using a soft muslin cloth and reweighted. The conventional compressed tablets that lose less
acceptable. The friability was calculated by following W1= Initial weight of tablets, W2= Final weight of tablets. Procedure was repeated three times for mean friability value 2, 19.
2. Tablet Hardness test: Randomly three tablets was pickup and they were individually tested for the hardness by Monsanto hardness tester (Shital
scientific industries Sr. no. 11012010) in term of kg/cm. the hardness of 4 kg is considered to be minimum for a satisfactory tablet 2, 19.
3. Disintegration test: Disintegration testing
apparatus manufactured as per USP (TAB machine
mod. no. TD 20S) was used for determination of disintegration time. In apparatus there was 6 glass
tube of length 3 inches, open at top and hold a 10 no.
56
mesh screen at bottom end of the basket rack
assembly. One tablet was placed in each tube of 2 basket rack assemblies of disintegration apparatus and perforated plastic discs placed at top of the tablets and impart an abrasive action of the tablets. Basket rack
was positioned in a one liter beaker filled with distilled water at 37°c ±2°c. The procedure was started for running disintegration time for uncoated tablets. At
last when tablets completely disintegrate and all
particles of tablet pass through 10 no. mesh, then time of disintegration was noted. Uncoated USP tablets
have disintegration time standard minimum 5 min, majority of the tablets have maximum disintegration time of 30 min . 19
4. Weight variation: (USP weight variation test) 20 tablets were select randomly from batch and weighing was done individually, average weight was calculated.
Individual weights were compared to average weight.
If not more than 2 tablets are outside the percentage limit, then tablets meet the USP test. The weight variation tolerance for uncoated tablet according to
USP is shown in table. Tested tablet was in more than
324 mg category. (Weight variation for average weight of uncoated Tablets more than 324 mg was
Journal of Research in Unani Medicine, Vol 4, Issue 1
followed i.e. maximum percentage difference allowed is 5%) 19.
Ideal final batch selected by above set parameters i.e.
friability, hardness, disintegration time was again prepared to check the reproducibility. Results
Identification: All the ingredients were authenticated
by the expert except Gile Armani. Gile Armani (clay/mineral) sample were analyzed by XRD studies for its authentication, XRD findings of Gile Armani
showed presence of Fe2O3-Hematite; Silica (SiO2)Quarts alpha; CaCO3- Calcite form and TiO2Titanium Oxide, Anatase. Its constituents resembled
Red Ochre (Geru).[20] This sample of Gile Armani was taken in the study as it is the readily available market
sample. This sample was identified as Geru which is a
genuine substitute of Gile Armani in Unani text 21. Yield of powders: Yields of powders by sieving it with 80, 100 and 120 no. sieves for Tabasheer were 80%, 76% and 71% ; for Gule Surkh 91.4%, 86.8% and 84.5%; for Gulnar 78.8%, 74.4% and 68%; for Gile Armani 97.14%, 96% and 94.28%; for Tukhme Khurfa 59.65%, 64% and 63% and for Tukhme Kahu were 62%, 65% and 63% respectively. Precompression parameter of final batch was found to be good 2, 16, 17, 18. Table 3 summarises the compression parameters.
Table 3: Pre-compressions parameters of ideal batch Qurse Tabasheer
Sr.
Pre-compressions
1.
Bulk Density (gm/ml)
0.5084 ± 0.0
-----
Compressibility index (%)
13.56 ± 0.9786
up to 15 Good F.P.*
No. 2. 3. 4. 5.
parameters of granules Tapped Density (gm/ml) Hausner´s ratio
Angle of Repose θ
*F.P (Flow property)
Mean ± SEM Value
0.5884 ± 0.006669 1.157 ± 0.01311
29.98°
Range
-----
< 1.25 Good
up to 40° reasonable F.P.* 57
Journal of Research in Unani Medicine, Vol 4, Issue 1
Friability, Hardness, Disintegration time of all batches of Qurse Tabasheer: The mean value of all 18 batches mentioned in Table 4, Figure 2, Figure 3 and Figure 4. Table 4: Results of all batches of Qurse Tabasheer Sr.
No
Sieve No.
Partic
le size (µm)
S.A.
Duration
Post
Friabilit
r
granules at
n drying
Mean ±
Binde (%)
of drying 60°C
1.
80
180
10%
30 min
2.
80
180
10%
3.
80
180
4.
80
5.
compressio time at 60°C
y (%) SEM
30 min
0.723±0.
60 min
30 min
0.68±0.0
15%
30 min
30 min
180
15%
60 min
30 min
80
180
20%
30 min
30 min
6.
80
180
20%
60 min
30 min
7.
100
150
10%
30 min
30 min
8.
100
150
10%
60 min
30 min
9.
100
150
15%
30 min
30 min
10.
100
150
15%
60 min
30 min
11.
100
150
20%
30 min
30 min
12.
100
150
20%
60 min
30 min
13.
120
125
10%
30 min
30 min
14.
120
125
10%
60 min
30 min
15.
120
125
15%
30 min
30 min
16.
120
125
15%
60 min
30 min
17.
120
125
20%
30 min
30 min
035
Hardnes s
(kg/cm2 )
Mean ± SEM
0.66±0.0 83
Disintegrati on time
(Minutes) Mean ± SEM
6.37±0.08
1.10±0.0
8.25±0.49
1.833±0.
11.80±0.32
2.10±0.0
17.053±0.32
1.966±0.
24.38±0.46
2.20±.02
25.18±0.56
1.166±0.
13.96±0.22
1.75±000
14.96±0.20
0.19±0.0
2.50±0.1
16.54±0.85
0.096±0.
2.75±0.1
23.11±0.87
3.916±0.
23.86±0.64
4.10±0.0
26.16±0.54
1.916±0.
5.95±0.42
2.33±0.0
7.29±0.49
2.916±0.
12.16±0.49
3.10±0.0
15.56±0.27
3.83±0.0
22.603±0.33
32
0.539±0. 03
0.463±0. 01
0.460±0. 02
0.336±0. 10
0.446±0. 02
0.326±0. 05 2
02
0.116±0.
02
0.0730±0 .02
0.75±0.0 3
0.41±0.0 2
0.173±0. 01
0.16±0.0 1
0.107±0.
5
08333 5
08333 887
08333
443 443
08333 5
08333 8333
08333 5
58
Journal of Research in Unani Medicine, Vol 4, Issue 1
Figure 2: Friability of Qurse Tabasheer batches Figure 3: Hardness of batches of Qurse Tabasheer
Figure 4: Disintegration time of batches of Qurse Tabasheer
Friability, hardness, disintegration time, of final selected batch: Friability, hardness, disintegration time, of final selected batch was 0.0730±.01764, 4.10±.050, 26.16±0.5376, respectively.
Average weight and weight variation: Average weight of tablets of final selected batch was 793.7 ± 4.755 mg and weight variation was < 5%.
Comparison of ideal batch no. 12 and repeated ideal batch prepared following specification of ideal batch, shows comparative friability, hardness and disintegration time [Table 5] Total time of preparation, quantity of tablet obtained and residue left of final selected ideal batch and two repeated ideal batches is mentioned in [Table 6]. Standard preparation specification for Qurse Tabasheer after validation is summarized in [Table 7].
59
Journal of Research in Unani Medicine, Vol 4, Issue 1
Table 5: Compression of ideal batch no. 12 and repeated ideal batch
Parameters
Ideal batch
Friability (%)
0.0730.01764
no. 12
Hardness (kg/cm2 )
Disintegrationtime (min.)
In aqueous medium (distilled water)
In simulated gastric fluid (dist. water with 0.1M HCl)
No. 1. 2. 3. 4. 5. 6. 7. 8. 9.
Parameters
Quantity of binder (g) (20 % of total wt. of
drug powder)
0.09±0.0057
4.03±0.087
26.16±0.5376
25.57±0.4860
25.19±0.1110
24.72±0.1881
Batch I
Batch II
Batch III
no. 12)
ideal batch 1)
ideal batch 2)
(Ideal batch
Quantity of drugs powder (g)
batch 1
4.10±.05
Table 6: Detail of Preparation of Qurse Tabasheer final batch
Sr.
Repeated ideal
120 24
(Repeated 120 24
1.2
1.2
Percentage of binder in Tablet
16.39%
16.39%
16.39%
Quantity of glidant (g)
1.2
1.2
48-50
48-50
48-50
Quantity of tablets obtained (%)
77.97
79.18
77.13
Quantity of tablets obtained (g)
Quantity of residue after making tablet (g)
114
18.5
116 16
3.
Powder size
Binder and it’s concentration
Kahu and Tukhme khurfa and then drying. 100 no. mesh sieve
4.
Granules size
16 no. mesh Sieve
5. 6. 7.
1.2
Total time for preparation of tablets (hr)
Standard specification forQurse Tabasheer
2.
24
1.2
Preparation procedure
1.
120
Quantity of lubricant (g)
Table 7: Standard specification of preparation for Qurse Tabasheer Sr. no.
(Repeated
Grinding
Temperature and duration of drying granules Compression machine and pressure
113
19.5
Dry grinding for all drug, and wet grinding for Tukhme
Gum acacia 20% of total w.t. of drug powder (30% w/w solution in distilled / R.O water)
of
Post-compression (Tablets) temperature and duration of drying
60°C for 60 minutes Multi-station rotary presses at 6 tons pressure
60°C for 30 minutes
60
Journal of Research in Unani Medicine, Vol 4, Issue 1
Discussion
Process standardization of Qurse Tabasheer starts
from powdering of crude drugs, Quality of good tablet also depends on the particle size of the
ingredients and attempt have been made to maintain the uniform particle size in respect of Sieve no. Some of the drugs in formulation were very tough and fibrous such as Tukhme Khurfa and
Tukhme Kahu and particle size of 100 and 120 mesh sieve was achieved with the help of wet grinding then drying of wet mass to prevent
growth of micro-organism, high yield was also
achieved by this method. Rest of the drugs easily passes through no. 80,100 and 120 mesh sieve.
Maximum yield of powder was achieved for Gile Armani.
Without lubricant and glidant good flow in granules
was observed in pilot batches but keeping in mind industrial production in bulk, magnesium carbonate and liquid paraffin were used as a
glidant and lubricant in 1% concentration . They 14
were added just before compression and mixed or tumbled gently without breaking granules to fine
particle magnesium carbonate was first sieve through 100 mesh to break the lump / agglomerate
(bolting) . Presence of clay and silica in large 12
quantity as a constituents in its ingredients such as in Gile Armani and Tabasheer, may be working as
a disintegrant and glidants. No scratches and fracture on edges of tablets or any other defect were observed in the final batch. Different excipients such as binders (PVP, gelatin, other
natural binders), glidant and lubricant can be tried for future studies. High concentration of binder Gum Acacia (16%) in final selected batch to maintain the quality can be justifiable owing to its
probable role in diabetes with its hypoglycemic activity, and might be further aiding in the
hypoglycemic activity of formulation 22. Binder is added as solution in the powder for preparation of
granules as they are more effective in solution form
19
. Some percentage of fines was also
observed in granules, care was taken in mixing of
binders and drying so that problem during compression would be avoided. It was observed that granules dried for 60 minutes at 60°C and
post-compression drying for 30 minute at 60° C
achieved better friability and hardness when compared to the batch in which granules were
dried for 30 minutes. Drying is required in all wet granulation procedure; in 60 minute drying
probably water was removed to the optimum level
of concentration within the granules helping to attain control over microbial content.
During
drying inter particulate bonds result from fusion or
re-crystallization and curing of the binding agent (Van der Waals forces playing a significant role),
drying of wet granules was done soon after
preparation as natural gums are usually
contaminated with bacteria 19. Post-compression drying was done to further overcome the moisture
and contamination issue. Decrease in friability was noted on increase of binders in different
batches, and increase in binder concentration also increase the hardness and it was also observed that
increasing in drying time i.e. up to 60 minute also increase the hardness, efforts were made to
maintain hardness of 4kg to improve the strength of tablet 12 as lesser hardness and excess friability is
commonly encountered in Unani tablets. Process of compression of dried granules with lubricant
and glidant in tablet presses was uneventful and
61
Journal of Research in Unani Medicine, Vol 4, Issue 1
smooth.
Batch no. 12 (100 no. mesh sieve powder) and 18
(120 no. mesh sieve powder) were found to be in acceptance criteria meeting their quality attributes. Friability, hardness and disintegration of batch no.
12 and 18 was 0.0730.01764, 4.10±.05, 26.16±0.5376 and 0.093±0.01453, 4.21±0.1485,
27.366±0.4767 respectively with 20% binder, and 60 minute granules drying time in both the batches. Pre-compression parameter of batch no. 12 was good, Compressibility index was 13.56%
and up to 15% usually indicated good to excellent flow property for achieving good quality of tablet
18
. Out of this, batch no. 12 was selected as final
batch on the basis of lowest friability, greater
hardness and good disintegration time and other
factors such as reference regarding mesh size mention in NFUM and Unani Pharmacopoeia of
Qurse Tabasheer which can exert above mention mechanism such silica content in Tabasheer and
Gile Armani and fiber content in other drugs can act locally and remaining in gut (small intestine) of these ingredient for longer time where glucose
absorption take place can be beneficial and drug like Punica granatum peel (rind) extract exert
action like protection of pancreas, stimulation of ß cells, increase number of ß cells and subsequent
release of insulin.[25] Appearance, colour, smell,
taste and texture of final ideal batch were looking acceptable. When final ideal batch was repeated to check the reproducibility by following its
manufacturing specification it also demonstrated results under the set parameters. Further detailed pharmacodynamic and pharmacokinetic study of
Qurse Tabsheer is needed to establish proper particle size with sophisticated mechanism.
India (fine powder passed through no. 100 mesh
Conclusion
production regarding particle size reduction to no.
pharmacopeial standard of Unani formulation,
Sieve),
feasible process for industrial level
9,10
100 mesh sieve as it was observe that it is difficult
to obtain powder of 120 mesh no. due to tough nature of some drug present in the formulation, to
increase the retention time of drug for intervention / local action in gut for glucose absorption if any in comparison with particle size 120 mesh as surface
The present study was undertaken to establish the Qurse Tabasheer to some extent. This work may
be of utility in improving the quality when comparing parameters as it shows reproducible
results. This SOP may be used for future reference for production of ideal Qurse Tabasheer quality wise.
area of no.120 mesh powder will be more and
Acknowledgment
size powder. Traditional / herbal medicines for
gratefulness to Prof. M.A Siddiqui, Director,
probably it will absorb faster than no. 100 mesh diabetes can act in four way as per mode of action: act like insulin, act on insulin secreting beta cells,
act by modifying glucose utilization and act by miscellaneous mechanisms (dietary fiber content,
reducing or slowing glucose / carbohydrate absorption)
[23,24]
there are many constituent in
The authors would like to express their National Institute of Unani Medicine (NIUM)
Bangalore, for providing all the necessary assistant and stimulation to work and to all the
Pharmacy staff of NIUM Pharmacy, also thankful to Prof Dr. Satyam Suhas Incharge CCD facility,
IISc (Indian Institute of Sciences) Bangalore for
62
help in XRD analysis.
References
1. Abdin MZ, Abrol YP. (eds.) Traditional System of Medicine. New Delhi: Narosa Publishing House; 2006. P. 114, 123, 13.
2. Manjula S, Shashidhara S, Anita S, Shilpa S.
Journal of Research in Unani Medicine, Vol 4, Issue 1
Unani, Siddha and Homoeopathy (AYUSH), Govt. of India; 2007. p. 269, 278.
10. National Formulary of Unani Medicine. (Urdu
Edition). Part.III. Vol. 1st. New Delhi: Department of AYUSH, Ministry of Health & Family Welfare, Government of India; 2005. p. 7,141.
Design Development and Evoluation of Herbal
11.Waring EJ. Pharmacopeia of India. Delhi: Asiatic
Phylanthus amarus. Pharma Science Monitor An
12. Rudnic EM., Schwartz JB. Oral solid dosage
Tablets Containing Andrographis paniculata and
International Journal of Pharmaceutical Science 2012;3(4):2352-2362.
3. Kabir al-Din, Hakim Muhammad [1894-
1976A.D.], Bayaz Kabeer. Vol 2, Hyderabad. Hikmat Book Depot, 1955; 146.
4. Hafeez A. Qarabadeen Jadeed. New Delhi,
Central Council for Research in Unani Medicine; 2005. p. 167.
5. Rahman ZS. Kitab Al Murakkabat. Aligarh: Ibne SinaAcadmy; 2010. p. 131-133.
6. Jeelani G. Kitabul Murakkabat Almaruf
Makhzanul Murakkabat. Delhi: Aijaz Publishing House; 1995. p. 270.
7. Bano S, Javed K, Jafri MA. Effect of Qurse Tabashir on Glucose tolerance test in Rats. In: Abdin MZ, Abrol YP. (eds.) Traditional System of
Publishing House; 2005. p. 62.
forms In: Troy BD. (eds), Remington the Science and Practice of Pharmacy. Vol. Ist. 21th ed. London: B. I. Publication; 2005. p. 898,892-93, 916.
13. Rasheed NMA, Gupta VC. Standardization of a
Compound Unani Herbal Formulation Qurse Luk with Modern Techniques. Pharmacognosy Research 2010;2(4):237-241.
14. Said HM. Hamdard Pharmacopeia of Eastern
Medicine. Pakistan: Hamdard Foundation; 1997. p. 217-218.
15. Raymond CR, Paul JS, Marian EQ. Handbook of
Pharmaceutical Excipients. 6 t h ed. UK: Pharmaceutical Press; 2009. p. 397.
16. General Chapters: <616> Bulk density and Tapped
density, 2011 The United States Pharmacopeial Convention 2011[Cited on 2014 Feb 13] Available from URL:
Medicine. New Delhi: Narosa Publishing House;
17. Musa A, Adamu BI, Teriyila SA and Musa I. Use of
8. Ahmed D, Sharma M, Mukerjee A, Kant RK,
in the Tablet Formulation of a Deliquescent Crude
2006. p. 304-307.
Kumar V. Antidiabetic, Anti-hyperlipidemic &
Hepatoprotective effect of a Polyherbal Unani formulation "Qurs Tabasheer" in STZ-diabetic
Hydrophobic Fumed Silica and Selected Binders Plant Extract: Vernonia Galamensis (Asteraceae).
Journal of Pharmaceutical and Biomedical sciences 2011;6(13):2.
wistar rats. BMC Complementary and Alternative
18. Marshall K. Compression and consolidation of
9. The Unani Pharmacopeia of India. Part II. Vol.1st.
Kanig JL. The Theory and Practice of Industrial
Medicine 2013;13(10)
New Delhi: Ministry of Health & Family Welfare,
Department of Ayurveda, Yoga & Naturopathy,
powdered solids In: Lachman L, Lieberman HA,
Pharmacy. 3rd ed. Mumbai: Varghese Publishing
63
Journal of Research in Unani Medicine, Vol 4, Issue 1
House; 1987. p. 77, 67.
1985; 5(12):1437-1441.
19. Gilbert S. and Neil RA. Tablets In: Lachman L,
23. Wadkar KA, Magdum CS, Patil SS and Naikwade
Practice of Industrial Pharmacy. 3 ed. Mumbai:
plants. Journal of Herbal Medicine and
Lieberman HA, Kanig JL. The Theory and rd
Varghese Publishing House; 1987. p. 295-320, 300, 320, 327.
20. Anonymous. The Ayurvedic Pharmacopeia of
India. Part I, Vol. 7th. ed. 1st. New Delhi: Ministry
NS. Anti-diabetic Potential and Indian medicinal Toxicology 2008; 2(1)45-50.
24. Sharma RD. Effect of fenugreek seeds and leaves
on blood glucose and serum insulin responses in human subjects. Nutr Res 1986; 6:1353-1364.
of H & FW, Dept of AYUSH, Govt. of India; 2009.
25. Enas AM, Khalil. Antidiabetic effect of an
21. Ghani N. Khazainul Advia. (reprint) New Delhi:
granatum L.) peels in normal and alloxan diabetic
p. 5-7.
Idara Kitabus- Shifa; 2010. p. 1127.
22. Sharma RD. Hypoglycemic effect of Gum Acacia in Healthy Human Subjects. Nutrition Research
aqueous extract of Pomegranate (Punica rats. The Egyptian Journal of Hospital Medicine 2004; 16:92-99.
64