Standard manufacturing procedure of qurse tabasheer a herbo mineral unani anti diabetic formulation

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.

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