ISSN   0974-3618  (Print)                    www.rjptonline.org

            0974-360X (Online)

 

RESEARCH ARTICLE

 

 

Formulation and Characterization of Metformin HCl Sustained Release Matrix Tablet by using Cassia tora  Mucilage

 

S. J. Daharwal1*, S Prakash Rao2, Vijay Kumar Singh2, Kunal Chandrakar2, Veena D. Singh1

1University Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur-492010, Chhattisgarh, India.

2Columbia Institute of Pharmacy, Tekari, Near Vidhan sabha Raipur, C.G. 493111, India

*Corresponding Author E-mail: daharwalresearch@rediffmail.com

 

 

ABSTRACT:

The present investigation is an attempt to study the formulation and evaluation of matrix tablet of Metformin HCl using natural mucilage of Cassia tora as a release retardant. The matrix tablet was formulated using different drug polymer ratio. The result of the pre-compression parameter like bulk density, tapped density, carr’s index and hausner ratio were found to be with the limits indicating good flow properties of the granules. Swelling index was found proportional to the concentration of mucilage. Formulation F-2 and F-3 showed 61% and 89.9 % respectively of swelling at the end of 5 h. In-vitro drug release for F3 formulation was found to be 75% at the end of 10 h. Drug release study has been suggested that release of drug from the matrix tablet get retarded with increasing mucilage concentration. Drug release profile of all formulations was plotted with different kinetics models. The regression coefficients showed best fit with higuchi model (r2= 0.958).

 

KEYWORDS: Cassia tora  mucilage, Metformine HCl, Matrix tablet.


 

 


INTRODUCTION:

The growing industrial utility of these gums in the field of paper, textile, petroleum recovery and pharmaceutical industries has resulted in an impetus in India for intensified research on new sources of gums and their modified products. Cassia tora  mucilage (CTM) derived from the seeds of Cassia tora  Linn. belonging to Caesalpiniaceae. It is a wild crop and grows in most parts of India as a weed and locally known as charota. A natural gelling agent which has industrial and food applications is made commercially from these seeds.1

 

 

 

 

 

 

 

 

 

 

Received on 02.06.2015          Modified on 22.06.2015

Accepted on 25.06.2015        © RJPT All right reserved

Research J. Pharm. and Tech. 8(7): July, 2015; Page 871-879

DOI: 10.5958/0974-360X.2015.00132.8

 

 

The objective of delivery system is to provide a therapeutically effective amount of drug to the proper site in the body.2 The two most important aspects of drug-delivery are spatial placement and temporal delivery of a drug. Spatial placement relates to the targeting a drug to a specific organ or tissue, while temporal delivery refers to controlling the rate of drug delivery to the target tissue.3,4An appropriately designed controlled-release drug-delivery system can be a major advance towards solving these two problems. Oral route is the most oldest and convenient route for the administration of therapeutic agents because of low cost of therapy and ease of administration leads to higher level of patient compliance.5 Sustained drug delivery system was aimed to release the medication in a prolonged rate to maintain plasma drug levels. The drugs having shorter half life are suitable for the sustained drug delivery system.6,7 Among the synthetic polymers hydrophilic polymers can be considered as release retardant but these polymers are quite expensive and their biodegradability is still unclear compared with natural polymers. Natural gums are biodegradable and nontoxic, furthermore it may swell quickly when come in contact with aqueous media.8 The use of natural gum for the development of formulation has witnessed a mammoth growth from last two decades.

 

The designing of formulations to reduce the frequency of dosing by modifying the rate of drug absorption has been in use since many years. Regular research is going on for the use of naturally occurring biocompatible polymeric materials in designing of formulations for oral sustained release administration.9,10 Among various dosage forms, matrix tablets are widely accepted for oral sustained release (SR) as they are simple and easy formulate. Matrix system is composite of one or more drugs with a gelling agent which prolongs and controls the release of drug.11,12 Metformin HCl, is an oral antidiabetic drug, belongs to class of biguanide derivatives, and remains the first line drug therapy for patients with type 2 diabetes mellitus. Metformin acts by decreasing hepatic glucose output and peripheral insulin resistance. It has relatively short plasma half life, low absolute bioavailability.13-15

 

The present study involved with formulation of metformin HCl. sustained released matrix tablet. However, many of the sustained release matrix tablets of metformin are available in the market. In this work we used mucilage of cassia tora  which can be considered as binder for the formulation. Instead of use of mucilage as a binder, cassia tora itself have antidiabetic activity. So, we hypothesised that using mucilage of cassia tora may contribute synergistic effect on antidaibetic activity. These work does not involved in assessment of antidaibetic activity of formulation. However, this article involved in formulation and characterization of sustained released matrix tablet of metfomin using mucilage of cassia tora as natural binder.

 

MATERIALS AND METHODS:

Cassia tora  seeds were procured from the forest of durg, Chhattisgarh, India. Metformin was obtained as gift sample from Active Pharmaceutical Ingredient. All other ingredients were of analytical grade and purchased from Samar chemical and SD Fine-chem Mumbai.

 

Isolation of mucilage from Cassia tora seeds

The seeds from Cassia were manually cleaned to remove external materials like straw, dust and soil. The damaged and prematured seeds were separated out. The seed were crushed into in mixer. The crushed seed material soaked in water for 5–6 hours, boiled for 30 minutes and left to stand for 1 hour to allow complete release of the mucilage into the water. The mucilage was extracted using a multi layer muslin cloth bag to remove the marc from the solution. Ethyl alcohol (three times the volume of filtrate) was added to precipitate the mucilage. The mucilage was separated, dried in an oven at 45ºC, collected, ground, passed through a # 80 sieve and stored in desiccator at 30ºC and 45% relative humidity before use. This mucilage was tested for following physicochemical properties. This mucilage was tested for following physicochemical properties. Chemical test, particle size, weight loss on drying, viscosity, ph, density, charring, swelling ratio, bulk density, compressibility percentage, angle of repose, Carr’s index. All values were found to be satisfactory.16,17

 

Physicochemical properties of dried mucilage

The physicochemical properties such as solubility, pH, specific gravity and viscosity of dried

CTM were determined at 20ºC. The loss on drying, total ash content, acid insoluble ash and water soluble ash were determined according to Ayurvedic Pharmacopoeia of India (A.P.I).18,19

 

Drug excipient compatibility studies

Compatibility of excipients with metformin hydrochloride was studied by Fourier Transform Infrared (FTIR) Spectroscopy. The FT-IR spectra of all combinations containing drug and one or more polymers also show the characteristic peaks same as that of the pure drug. The FT-IR spectrum of all the combinations containing drug and one or more polymer or gum shows same or slightly shift in peak values when compared with the characteristic peak values of pure drug .21

 

Preparation of calibration curve in 6.8 phosphate buffer

Preparation of buffers and reagents

The phosphate buffer solution of pH 6.8 was prepared by mixing 250 ml of 0.2 M Potassium dihydrogen orthophosphate and 112 ml of 0.2 M NaOH and adjusts the volume of resulting solution upto 1000 ml with water in a volumetric flask.

 

Calibration curve Metformin HCl in pH 6.8 phosphate buffer

Accurately weighed metformin hydrochloride (50 mg) was dissolved in solution of phosphate buffer solution of pH, 6.8 and further dilution were made to get solution of concentrations from 2 to 10 ug/ml. Absorbance of the solution were determine by using UV spectrophotometer at the wavelength of 233 nm.

Table :1 formulation chart of Metformin HCl.

S.No

Ingredients (mg)

F1

F2

F3

F4

1

Metformin hydrochloride

200

200

200

200

2

Xanthan gum

20

20

20

 

3

Ethyl cellulose

100

100

100

100

4

HPMC

50

50

50

70

5

Microcrystalline cellulose

80

70

60

80

6

Cassia tora 

30

40

50

30

7

Isopropyl alcohol

Q.S

Q.S

Q.S

Q.S

8

Mag. stearate

10

10

10

10

9

Talc

10

10

10

10

 

Preparation of metformin hydrochloride sustained release matrix tablet by wet granulation method

Preparation of granules

Granules of metformin hydrochloride was prepared by wet granulation technology. All the corresponding powder (metformin hydrochloride, Ethyl cellulose, Xanthan gum, Hydroxypropyl Methyl Cellulose) were weight individually as per formulation chart .then the powder was added in ascending order and mixed with double cone blender for 30 minutes a soft mass was formed by using CTM paste. The wet mass was then passed through a sieve no.22.the prepared granules were then passed through a sieve no.44.then calculated quantity of talk and magnesium stearate were added as mixed uniformly. These granules were then stored in an air tight container till further processing.22,23

                                               

Evaluation of precomresion parameter

Granules prepared by wet  granulation technology were evaluated for various rheological properties like bulk density,tapped density ,carr’s index,hausner’s ratio and angle of repose by using standard procedure .all these properties were carried out in triplicate (n=3) and average values were reported.24

 

Angle of repose

Angle of repose is defined as, “the maximum angle possible between the surface of pile of Powder and horizontal plane”. The angle of repose for powder of each formulation was determined by the fixed funnel method. A funnel was kept vertically in a stand at a specified height above a paper placed on a horizontal surface. The funnel bottom is closed and 10 gm of sample powder is filled in funnel. Then funnel was opened to release the powder on the paper to form a smooth conical heap, is found by measuring in different direction. The height of the heap was measured by using scale. The value of angle of repose is calculated by using the following formula:

 

θ = tan-1 = h/r,

Where, h- height of the heap, r-radius of the heap

 

Tapped density

Tapped density was determined by placing the granules in a measuring cylinder and the tapped volume (Vo) of granules after 100 tapping’s noted .the total mass of granules (M) was determined.tapped density was calculated by using the following formula.25

 

Tapped Density = Vb /Vf

 

Where Vb – tapped volume, Vf – final tapped volume

 

 

 

Bulk density

A known quantity of powder was poured into the measuring cylinder carefully level the powder without compacting, if necessary and read the unsettled apparent volume, V0, to the nearest graduated unit. Calculate the bulk density, in gm per ml, by the formula,

 

Bulk Density = m / V0,

Where m - Unsettled, V0 - apparent volume

 

Compressibility index

The compressibility Index was calculated by using measured values for bulk density and tapped density as follows:

Compressibility index = [(Vt-Vb)/Vt] x100

 

Where Vt = tapped density, Vb = bulk density

 

Hausner’s ratio

The hausner’s ratio was calculated by using measured values for bulk density and tapped

Density as follows:

 

Hausner Ratio = Dt/Do

 

Where Dt = tapped density, Do = bulk density

 

Evaluation of tablets26,27

Thickness and Diameter

Thickness and diameter of tablets was determined using Vernier Caliper. Five tablets from

Each batch was used, and average values were calculated.

 

Hardness of the Tablet

Tablet hardness has been defined as, “the force required breaking a tablet in a diametric Compression test”. For each formulation, the hardness of three tablets was determined using Monsanto hardness tester.

 

The tablet was placed in “Monsanto hardness tester’’, the tablet was placed in Monsanto hardness tester vertically and the force was applied with the help of screw the end point was detected by breaking the tablet.

 

Weight variation test

Twenty tablets were randomly selected and weighed to determine the average weight and were compared with individual tablet weight. The percentage weight variation was calculated as per Indian Pharmacopoeial Specification. Tablets with an average weight more than 400 mg should not be more than ±5 %. This is an important process which comes under quality control test .according to standard in one batch all tablet should be in uniform weight .the weight variation test was performed with the help of digital weighing balance. From the one batch 20 tablets were selected randomly as sample and their individual weight was determined and average weight was determined .finally percentage deviation was calculated by the using following formula:

 

Percentage deviation =(Individual weight –Average weight)   X 100

                                                  Average Weight

 

Friability test

10 tablets from each batch were selected randomly selected from the batch as a sample and their collectively initial weight was determined.aal the tablet were placed in friabilator and rotated for 100 revolution at 25 RPM. After rotation final weight was determined. The percentage of friability was calculated by following formula. According to standard the weight loss should not be more than 1%.

 

Following formula was used to calculate the friability

F = (1- W/Wo) 100……………. (4)

 

Where,

Wo - Weight of tablet before test.

W- Weight of tablet after test.

 

Friability percentage =       ( Initial weight – Final weight)   X 100

                                                       Initial weight                                                           

 

 

 

Determination of drug content

The drug content of metformin hydrochloride was determined with the help of ph 7.4 phosphate buffer solution .tablets were placed in 100 ml of ph 6.4 phosphate buffer solution individually . It was kept for 24 hours in room temperature and filtered. 1ml. of solution was withdrawn and diluted up to 10 ml with the help of ph 6.4 phosphate buffer solution and absorbance was recorded by uv –visible spectrophotometer at 233 nm. Finally the drug content was determined by using calibration curve.

 

In –vitro dissolution study

Dissolution study of metformin hydrochloride tablet was performed with the help of united states pharmacopoeia (USP) XXIII dissolution testing apparatus I(basket type ).900 ml of phosphate buffer solution PH6.4 was taken in dissolution vessel as media and warmed at 37 ±0.5C.the media was stirred at 50Mrpm. 5ml sample from dissolution  vessel as media was added maintain the shrink condition .the sample was diluted up to 10 ml and absorbance of these solution measured at 237 nm using the equation obtained from a standard calibration curve . Finally graph was plotted between time in X axis and cumulative percentage drug release in y axis.

 

 

Drug release kinetics 6

The dissolution data obtained were fitted into following kinetic model. This was to determine the mechanism of drug release.

 

Zero-Order Kinetics

Zero order as cumulative amount of drug released vs time,

C = K 0 t

Where K0 is the zero-order rate constant expressed in units of concentration/time and t is the time in hours. A graph of concentration vs time would yield a straight line with a slope equal to K0 and intercept the origin of the axes.28,29

 

First Order Kinetics

The application of this model to drug dissolution studies used to describe absorption and/or elimination of drugs. To study the first order release rate kinetics the release rate data were fitted to the following equation

 

Log Qt = log Q0 + K1t / 2.303

 

Q t is the amount of drug released in time t

Q0 is the initial amount of drug in the solution K1 is the first order release constant.

                                                  

Higuchi Model

Higuchi developed several theoretical models to study the release of water soluble and low soluble drugs incorporated in semi-solid and/or solid matrixes. Mathematical expressions were obtained for drug particles dispersed in a uniform matrix behaving as the diffusion media, the equation is

 

Qt = KH.t1/2

 

Qt is the amount of drug released in time t KH is higuchi dissolution constant. Higuchi describes drug release as a diffusion process based in the Fick’s law, square root time dependent.30,31

 

Korsmeyer and Peppas Model

This model is generally used to analyze the release of pharmaceutical polymeric dosage forms, when the release mechanism is not well known or when more than one type of release phenomena could be involved.

 

Mt / M = K.tn

Mt /M is the fraction of drug release K is the release constant, t is the release time n is the diffusion exponent for the drug release that is dependent on the shape of the  matrix dosage form.

 

 

Where Mt/M∞ is the fractional solute release, t is the release time, K is a kinetic constant characteristic of the drug/polymer system, and n is an exponent that characterizes the mechanism of release of tracers. For cylindrical matrix tablets, if the exponent n = 0.45, then the drug release mechanism is Fickian diffusion, and if 0.45 < n < 0.89, then it is non-Fickian or anomalous diffusion. An exponent value of 0.89 is indicative of Case-II Transport or typical zero-order release.32

 

Polymer Swelling or Water Uptake studies

The swelling behavior of batches F2, F3, was studied. The tablets (n=3) were kept in Petri dish containing 25ml distilled water at 37±2°C at selected time points, the tablets were withdrawn, wiped with tissue paper, and weighed. The percent water uptake by the tablet was calculated using the following formula:

 

Percentage water uptake = 100 × [Wt - W0/W0]

 

Where, Wt was weight of tablet at time t and W0 was initial weight of the tablet

 

 

RESULT AND DISCUSSION:

Preformulation studies

The drug sample was evaluated for its colour and odor.

 

Table: 2 Identification of Drug

S.No

Parameter

Drug

1

Color

White

2

Odour

odourless

3

Taste

tasteless

4

Appearance

Crystalline powder

                                       

 

Determination Melting point

 Melting point of the drug sample was determined by capillary method by using melting point apparatus.

 

Table:3 Melting Point of Pure Drug

S.No

Reported melting point

Observed melting point

1

222-2260c

222-2240c

                                        

Solubility study

The solubility of the metformin HCl was determined by adding excess amount of drug in the solvent and equilibrium solubility was determined by taking supernated and analyzing it on Shimadzu UV-Double beam spectrophotometer. The solubility of the metformin HCL was found to be slightly soluble in water and freely soluble in acetone.

 

Table: 4 Solubility of Metformin HCl in different solvent

S.No

Medium found

%Found

Mg/100ml

1

Water

99.58%

99.58

2

0.1N HCL

100.10%

100.10

3

Phosphate buffer pH (6.8)

99.65%

99.65

 

Table:5  physicochemical properties of cassia tora musilage

S.No.

Parameter

Result

1

Appearance

Yellow white powder

2

Solubility

Soluble in cold water and hot water forming viscous colloidal solution

3

Swelling index (%)

33.0 ± 0.15

4

pH

5.5 - 6.5

5

Hot viscosity (1.0%w/v solution)

20 -100 cps

Values are mean ± S.D. for n=3

 

   

Table:6  Physicochemical properties of dried mucilage

S.No

Properties

Result

Type of flow

1

Angle of repose

25

Good flow

2

Bulk density

0.600 ± 0.05

Good

3

Tapped density

0.625 ± 0.04

Good

4

Compressibility index

7.97± 0.78

Excellent

Values are mean ± S.D. for n=3

 

FTIR spectrum of metformin  HCl

FTIR spectroscopy was performed for the identification of pure drug. The spectra was obtained from the FTIR spectrometer  at the wavelength from  4000cm-1 to 400 cm-1 is present  at figure no and the characteristic peaks which was obtained  is present in table no .

 

Fig: 1 FTIR Spectra of Pure Drug Sample of Metformin HCl

 

 

FTIR Spectra of CTM

Fig : 2 FTIR Spectra of  CTM

 

Drug – excipients compatibility study:

Fig : 3 FTIR Spectra Ratio of CTM and Metformin HCl

 

Fig:4  FTIR spectra of Metformin HCl tablet formulation

Fig : 5 Drug – polymer compatibility study

 

Calibration curve of Metformin HCl

Concentration (μg/ml)

Absorbance (233nm)

2

0.159

4

0.319

6

0.481

8

0.647

10

0.802

 

Fig:6  Standard Calibration Curve of Metformin HCl in Phosphate Buffer Ph 6.8

 


 

 

Evaluation of Table

Table:7  Precompression parameter of Metformin HCl granules

S. No

Formulation  code

Bulk Density (g/ml) ±S.D

Tapped Density  (g/ml)± S.D

Compressibility Index (%) ±S.D

Hausner’s Ratio ±S.D

Angle of repose

±S.D

1

F-1

0.547±0.018

0.55±0.57

7.33±3.550

1.07±0.0416

27.9±1.34

2

F-2

0.54±0.0208

0.586±0.011

7.33±3.55

1.253±0332

26.40±0.70

3

F-4

0.53±0.0251

0.533±0.057

6.9±7.078

1±0.149

26.55±0.915

4

F-11

0.53±0.0264

0.556±0.053

5.58±6.42

0.97±0.110

27.01±0.455

All values are mean ± S.D. for n=3

 

Table: 8 Evaluation of Metformin HCl Tablet

Formulation no

Thickness(mm)

Hardness(kg/cm2)

Friability

(%)

Average  weight (mg)

Weight  variation

F1

5.85±0.045

6±0.854

0.146±0.08

506.1±367

pass

F2

5.73±0.06

6.4±0.96

0.109±0.038

503.1±1.95

pass

F3

5.81±0.102

5.66±0.51

0.105±0.046

506.1±3.66

pass

F4

5.79±0.08

6.26±0.90

0.146±0.087

503.2±2.05

pass

 

 


Drug content

Table:  9 The Drug Content of Different Formulation

S.No

Formulation code

Drug contant (%)

1

F1

99.89

2

F2

99.53

3

F3

99.44

 

 

Table:10 Drug Content of Different Formulation

Among the different formulation the drug content of tablet 99.53 % of metformin HCl 500 mg.

S.NO

F2

F3

1

30.2

40.7

3

40.8

51.4

5

46.8

62.3

7

53.8

73

10

60.1

89.9

 

Swelling Behavior SR Matrix Tablets of Metformin HCl

 

Fig:7  After  3 Hours of Swelling (F1-F3)

 

 

 Fig:8  After  5 hours of swelling (F2-F3)

 

 


Fig:9  After  10 Hours of Swelling (F2-F3)

Fig:10  Relationship between Swelling index and Time (Batch F2 to F3)

 

In vitro drug release: in vitro drug release of different formulation are shown in tablet no.11.

 

Table:11

TIME (hr)

F1

F2

F3

F4

0

0

0

0

0

0.5

11.8

11.25

10.12

10.6

1

18

17.4

27

18.6

3

38.25

21.37

32.62

30.93

5

41

32.62

49.5

38.81

7

46.125

45

52.3

41

9

49.5

55.125

59.56

47.8

10

79.87

74.25

61.2

65

12

88.6

84.37

90.56

74.8

 

Fig: 11  drug release kinetics of Different Formulation

 

 

 

 

 

 

 

 

 

Table:12. Drug release kinetics of different formulation.

F. Code

Zero  order R2

First order R2  Value

Higuchi Equation R2

Korsmeyer Model R2 Values

F1

0.856

0.824

0.838

0.756

F2

0.900

0.900

0.976

0.566

F3

0.951

0.951

0.958

0.550

F4

0.927

0.926

0.920

0.729

 

Table:15  Drug Release Kinetics of Different Formulation

Fig:12  Zero Order Kinetic Models of Formulation F1, F2, F3 and F4

 

Fig:13  First Order Kinetic Models of Formulation of F1, F2, F3 and F4

Fig:14   Higuchi Models of Formulation F1, F2, F3 and F4

Fig:15  Korsmeyes Peppas Kinetic Models of Formulation F1, F2, F3 and F4

 

Accelerated stability studies

The stability study of optimized batch was carried out at 25°C/60% RH, 30°C/65% RH and 40°C/75% RH as per ICH guidelines. The tablets of all formulation were found to be stable at Such condition and other parameters were found to be unaffected and were under pharmacopoeial limits.

 

DISCUSSION:

In preformulation studies drug sample was procured and identified by comparing the FTIR Spectrum with standard reference , and the sample have all the peak according to standard reference .for the identification of the drug their melting point and solubility test was determined . in which sample result was performed according to standard . The drug compatibility study was also performed with the help of FTIR, and there not any chemical interaction was found between drug and excipients at any formulation. The result of different evaluation parameter of prepared different Metformin HCL granules and tablet are shown in tablet no. Bulk density of the developed formulation F1 to F4 varied from 0.53±0.0251 gm/ml 0.54±0.0208, the tapped densities were varied from in the range of 0.533±0.0577 to 0.586±0.011 .the difference between tapped density and bulk density were near about same of all formulation except F4 formulation. The compressibility index value was found to be range of 5.58±6.42 to 7.33±3.550. these finding indicated that the powder mixture exhibited Excellent flow properties .The result of Hausner’s Ratio were ranged from 0.97±0.110 to 1.253±0332, which indicate good flow properties of F3 formulation and F2 formulation good flow properties. The angle of repose was ranged between 26.40±0.70 to 27.9±1.34, which indicates good flow property of powder. Thickness of the developed formulation varied from 5.73±0.06 mm to 5.85±0.045, which was uniformly throughout the batches and within the permissible limit .hardness varied from 5.66±0.51to 6.4±0.96 kg/cm2 which indicates tablets possess sufficient strength. The friability of all formulation  was found to be minimum from 0.146±0.08 to 0.109±0.038 %. Among all the formulation the friability of F1, F2, F3, F4 batch were good friability. The average weight of twenty tablets was calculated for each batch which varied from 503.1±1.95 to 506.1±367 mg , the percent deviation of all the formulations comply with weight variation test. In the formulation no F-1 EC 20% and HPMC 10%, xanthan gum 4% was using in CTM 6%, as decreased the concentration of polymer the release rate increase and only 80% drug release in 10 hrs. In the preparation of the tablets (F2), combination of HPMC and ethyl cellulose was used in 3 xanthane gum , Microcrystalline cellulose, Cassia tora, talc and  magnesium sterate  was used , and tablet were prepared by wet granulation technique , in which 500 mg  strength tablet was prepared with help of 9 mm diameter punch size , and the thickness was found to be 6.5mm , several batch were prepared to sustained the release of drug.

 

When dissolution study was performed for the tablet , due to presence of xanthane gum HPMC, EC  and CTM using tablet was hydrated and swelled upon contact with aqueous media and released rate F-2 and F-3 formulation 62-74.25 % drug release in 10 hrs the release kinetics was determined for the batches and formulation followed the Higuchi  model. The calculated regression coefficients showed a higher r2 value with Higichi model (r2= 0.958).  Hence the release data of the Tablet obeyed Higuchi model and release the drug  diffusion mechanism. For the above study it was conclude that sustained release matrix tablet using CTM can be prepared successfully in industrial scale.

 

CONCLUSION:

The present research work was undertaken with an objective to  reparation , formulation and evaluation metformin HCl tablet by altering polymer and CTM Mucilage (HPMC, EC, Xanthan gum and Cassia tora  Mucilage)  as a trial, for treatment of Antidiabetic. Primarily were prepared using wet granulation technique, and were evaluated as pharmacopoeial specification experimental work till done.

 

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