A Fast release tablet containing Herbal extracts (Ginger, Cinnamon, Turmeric, Long pepper and Punarnava)

 

Ruchika Sharma*, Dr. M. S. Ashawat, Prof. C. P. S Verma, Neha Kumari

Sri Sai College of Pharmacy, Badhani, Pathankot

Laurete Institute of Pharmacy, kathog, Jawalmukhi.

*Corresponding Author E-mail: Ruchikasharma471@gmail.com, neha91sn@gmail.com

 

ABSTRACT:

The aim of the present work is to formulate a fast release tablet containing herbal extracts (ginger, cinnamon, turmeric, long pepper and punarnava) as drug, by direct compression method. Tablets contain super-disintegrant which disintegrate and dissolve fast and give its rapid onset of action. The effect of various superdisintegrants on the disintegration was studied. Croscarmelose sodium (CCS), crospovidone (CP) and sodium starch glycolate (SSG) were selected as a superdisintegrants. The study involved chromatographic fingerprinting of five drug extracts; cinnamon (Cinnamomum Zeylanicum Nees), long pepper (Piper longum, Linn.), turmeric (curcuma longa linn), punarnava (Boerhaavia diffussa linn.) and ginger (Zingiber officinalis, Rosc.) for standardization followed by preparation of tablets by direct compression methods. Infrared (IR) spectroscopy, performed to check out compatibility of drug extracts and the excipients. Powder blend of drug and excipients was investigated for the micromeritic properties. Evaluation of FDT was carried out for appearance, hardness, thickness, and weight variation, friability, and disintegration time and dissolution studies. Dissolution studies were carried out of all the formulations (F1 – F9). All formulations are compared with the marketed formulation (MF) and it was found that prepared formulations show better results.

 

KEYWORDS: Extracts (ginger, cinnamon, long pepper, turmeric and punarnava), fast dissolving tablets, IR.

 

 


INTRODUCTION:

Ayurveda is a system of medicine with historical roots in the Indian subcontinent.1 Globalized and modernized practices derived from Ayurveda traditions are a type of complementary or alternative medicine. In countries beyond India, Ayurveda therapies and practices have been integrated in general wellness applications and in some cases in medicinal use.2,3 Ayurveda is an ancient system of life (ayur) knowledge (Veda) arising in Indian thousands of years ago. Ayurveda theory evolved from a deep understanding of creation. The great rishis or seers of ancient india came to understand creation through deep meditation and other spiritual practices.

 

Ayurveda was first recorded in the Veda, the world’s oldest existing literature. The three most important Veda texts containing the original and complete knowledge of Ayurveda, believed to be over 1200 years old, is still in use today. The herb, believed in Ayurvedic medicine to have medicinal properties, has been searched for unsuccessfully for centuries, upto modern times. The Himalayan state of Uttrakhand in Northen India committed an initial 250m rupee of state money to search for Sanjeevani booti starting in August 2016. The search was focused on the Dronagiri range of the Himalayas near the Chinese border. The Ramayana mentions a mountain believed to refer to the Dronagiri range, where the magical herb is supposed to grow. Uttarakhand established a Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (Ayush) in November 2014.5 Now a day the various dosage form are available to treat the patient in which, topical, inhalation, etc are common routes of administered the drug. Oral route is the most preferable route of delivering the drug because of various advantages like easy to medication, not special supervision or help required by the patient and very economically. Tablet is the most familiar dosage form among all the dosages either it is belong to oral and other administering route.6 Herbal medicine sometimes referred to as herbalism or botanical medicine is the use of herbs for their therapeutic or medicinal value. An herb is a plant or plant part value for its medicinal, aromatic and savory qualities. Herb plants produce and contain a variety of chemical substance that act upon a body. Herbal medicine is the oldest form of health care known to mind kind. Herbs had been used by all cutlers throughout history. It was an integral part of the development of modern civilization. The plants provided food, clothing, shelter and medicine. As time went on, tribe added the medicinal power of herbs in their area to its knowledge base. The methodically collected information on herbs and developed well define herbal pharmacopoeias.7 Many drugs commonly used today are of herbal origin. Indeed, about 25% of the prescription drugs dispensed in united state contain at least one active ingredient derived from plant material. Some are made from plant extracts; others are synthesis to mimic a natural plant compound. The world health organization (WHO) estimate direct 4billion people, 80% of the world population, presently use herbal medicine for some expect of primary health care. Herbal medicine is a major component in all indigenous people traditional medicine and a, common element in aryuevedic, homeopathic, naturopathic, traditional oriental, and native American Indian medicine. WHO notes that of 119 plants derived pharmaceutical medicine; about 74% are used in modern medicine in ways that correlated directly with their traditional uses as plant medicine by native cultures. By definition, “traditional” used of herbal medicine implies substantial historical views and this is certainly true for many product are availed as “traditional herbal medicine”.8 Neutraceuticals sometimes referred as “functional foods”, have caused heated debate because they change the traditional dividing line between food and medicine. A nutraceutical is “any non toxic food component that has scientifically proven health benefit including disease treatment or prevention”. Medicinal plants have curative properties due to the presence of various complex chemical substance of different composition which are found as secondary plant metabolite in one more plants of these plants. Plants are always exemplary source of drug. Infact, many of plant currently available drugs were derived directly or indirectly from the plants. The plant kingdoms a rich source of organic compounds many of which have been used for medicinal and other purpose. Herbal medcicne remains the measure source of health care for the world’s population.9 although modern medicine may exist side-by-side with such traditional practice, herbal medicines have often maintained their popularity for historical and cultural reasons. In the USA, by contrast, most herbal products in the marketplace are marketed and regulated as dietary supplements, a product category that does not require pre-approval of products on the basis of any of these criteria.10 According to WHO, 80% of the people living in rural areas depend on medicinal herbs as primary healthcare system. Nearly 1 in 5 adults in the United States report taking an herbal product.12

 

METHODOLOGY:

Pre-formulation:

The major goal of pre-formulation studies is the rational development of safe and efficacious dosage form. An inside info such parameter allows formulation to select the various additives and formulation conditions for the successful and effective drug delivery to the biological system. Here as the process of optimizing the delivery of drug through determination of physic-chemical properties of the compound that could affect performance.

 

Drug identification:

Physical characterization13:

Physical description of the herbal extracts ginger, turmeric, cinnamon, long pepper and punarnava was characterized by visually on the basis of colour, odour and texture.

 

Determination of melting point14,15:

The determination of melting point is a major identification characteristic in the pre-formulation study. The melting point and solubility are related via the latent heat of fusion process. The melting point of herbal extracts of ginger, turmeric, cinnamon, long pepper and punarnava was determined using digital melting point apparatus (Rolex, Ambala, India). Melting point of these 5 extracts was determined by capillary fusion method one sided closed capillary filled with drug and put into the digital melting point apparatus. Temperature was noted at which solid drug changed into liquid. Melting point was recorded and compared with literature.

 

Drug solubility16:

The solubility of all extract (ginger, turmeric, cinnamon, punaranava, long pepper) was determined in different solvent systems and buffers. An excess quantity of the drug was mixed with 10 mL of each solvent in flask and shaken occasionally for 24 hours at 25˚C. The solutions were examined physically for the absence or presence of drug particles and also by spectrophotometrically for quantitative determination of drug in buffer and solvents.

Fourier Transformer Infrared Spectroscopy (FTIR)17:

FTIR spectrum of all extract (Ginger, Turmeric, Cinnamon, Long pepper, Punaranava):

FTIR spectroscopy of all pure extract was carried out using FTIR (IR affinity-1, Shimadzu Corporation, Kyoto, Japan). Dried samples were mixed with dried potassium bromide (KBr) powder. The discs of sample were of approximately 0.1mm diameter of the drug was prepared grinding 3-4mg of sample with 100-150mg of potassium bromide using hydrostatic press. The sample pellet was mounted in IR compartment and scanned at wavelength 4000 cm-1 to 400-1.

 

Drug-excipients compatibility18:

Each of excipients spectra were obtained by using KBr press pellet technique. The excipient and KBr was used in the ratio of 1:100 and by applying pressure of 10 ton for 1 minute. The sample was then transferred to sample holder was scanned at 4000-400 cm-1 and the interpretation of the spectrum wasfurther done by comparing the spectrum with the spectrum of individual drug and excipients. The compatibility study of all extracts was done with superdisintegrats SSG (sodium starch glycolate)

 

Formulation development:

For the formulation development we were used 14 formulations by varying the various superdisintegrant in 5% and 10% for each. We have used 20mg dose of each extracts. Superdisintegrants crospovidone, croscarmellose sodium, sodium starch glycolate were used in herbal fast release tablets. These superdis integrants were used in variable concentration as mentioned above and shown in table 2.1.


 

Table 2. 1: Composition of different batches of FDT.

Ingredients

F1

F2

F3

F4

F5

F6

F7

F8

F9

mg

mg

mg

mg

mg

mg

mg

mg

mg

Cinnamon

20

20

20

20

20

20

20

20

20

Curcumin

20

20

20

20

20

20

20

20

20

Long pepper

20

20

20

20

20

20

20

20

20

Punaranava

20

20

20

20

20

20

20

20

20

Crospovidone

15

17

19

-

-

-

-

-

-

CCS

-

-

-

15

17

19

-

-

-

SSG

-

-

-

-

-

-

15

17

19

Lactose

40

40

40

40

40

40

40

40

40

Talc

10

10

10

10

10

10

10

10

10

MCC

75

73

71

75

73

71

75

73

71

Mg. Stearate

10

10

10

10

10

10

10

10

10

Net weight

250

250

250

250

250

250

250

250

250

Long pepper

20

20

20

20

20

20

20

20

20

 


Preparation Method:

In the present study we approach direct compression method for the development of Fast dissolving tablets. Direct compression method is most easy and suitable method approached by various formulation scientists. In this method all ingredients weighed according to their decreasing order of their weight. All ingredients passed through sieve #40. After sieve it was further analyzed for the organoleptic properties and micromeritics properties.

 

Powder blend characterization:

Angle of repose18,19:

Angle of repose is actually the maximum angle present between the surface of the pile of the powder and the horizontal plane. Angle of repose determined to evaluate the flow property. It is determined by using a funnel with the end of hollow tube just cut perpendicular to its axis of symmetry was fixed at a height above the paper placed on the plain horizontal surface. The powder was carefully poured in the funnel till the apex of the pile approximately touches the tip. The height of the pile (h) and radius (r) of the base was determined. The angle of repose (θ) was calculated using formula given below

              h

Tan θ =-----               

                 r

Where θ is angle of repose, h is height of cone and r is the radius of the base cone.

 

Loose bulk density20:

The loose bulk density was determined by taking sufficient weighed amount of powder in the measuring cylinder. In this initial volume occupied by the powder was recorded. It is defined as the ratio of weight of powder in grams to the loose bulk volume (cm3). Sample size (5g) was carefully poured in a 10 ml graduated measuring cylinder and LBD was determined using following formula

                                                  Weight of Powder

Loose of bulk density (LBD) =  ----------------------------

                                                        Bulk Volume

 

Tapped density19:

Tapped density determined by pouring fixed amount of powder in the measuring cylinder, its initial volume was recorded and measuring cylinder subjected to 100 drops. In this final volume occupied by the powder in the measuring cylinder was recorded and calculated against the weight of the powder. Tapped density is the weight per unit volume. Bulk density of powder is defined as the ratio of the powder weight to the bulk volume of the powder. Bulk density is important in checking the uniformity of bulk chemicals, selecting the size of container and blender and determining container size. For the determination of tapped density 5g of powder sample was carefully introduced in a 10ml graduated measuring cylinder. The tapped density calculated by using formula

                                Weight of Powder

Tapped density =------------------------------------

                                  Tapped Volume

 

Carr’s consolidation index18:

Compressibility is the capability of powder to drop off in volume under pressure. It can be determined by using density measurements. It is indirectly related to the relative flow rate. If the bed of particles is more compressible, the granules will be less flow able and vice-versa. Carr’s compressibility index was determined by the following formula

                                     Bulk density

Carr’s Index =   1-    ------------------------ X 100

                                    Tapped density

 

Hausner’s ratio:

Hausner’s ratio is an indirect index of ease of powder flow. Lower Hausner’s ratio (<1.25) indicates better flow properties. It is calculated by the following formula

                               Tapped density

Hausner’s ratio =   -----------------------

                                 Bulk density

Tablet compression:

We have used the direct compression method for tablet preparation. After powder blend evaluation different batches compressed by using tablet compressing machine (Karnavati) Rinek mini press-I.

 

Evaluation of fast release Tablets20:

The all prepared tablets from each formulation batch were subjected to quality control tests.

 

Appearance:

Appearance is the visual identity of the tablet and elegance is essential for patient’s acceptance. The tablets size, shape, color, odour pressure or absence like all parameters was studied.

 

Test for uniformity of weight:

According to USP determination of tablet weight was followed. 20 tablets were taken from each formulated batch and individual weight of each tablet determined using digital weighing balance (Wensar Magnetic Analytical Balance). The average weight of each tablet was determined. The weight variation was calculated for USP limits i.e. for average weight of 80mg or less, 80-250mg and more than 250mg; the maximum percentage difference allowed are 10%, 7.5% and 5% respectively.

 

Tablet thickness:

Tablet thickness was determined by using digital vernier calipers (Digital vernier caliper). Randomly 20 tablets were selected for the determination of thickness from each formulated batch.

 

Tablet Hardness:

Hardness of tablet is defined as the force applied across the diameter of the tablet in the order to break the tablet. Tablet hardness is less than 4kg/cm2 is considered adequate for mechanical stability of fast disintegrating tablets. The tablet hardness was determined by diametrical circular compression using a dial type Monsanto tablet hardness tester.

 

Friability:

Friability is the loss of fine particles mass from tablet surface in the container during handling and transportation. Friability was determined by using Roche friabilator (EF-2, Electrolab, Mumbai). Friability express in percentage (%). For friability transferred to the friabilator. friabilitor consist of circular plastic chamber which revolves at 25rpm for 4 min (100 revolution). In the chamber tablet dropped at the distance of 6 inches. After the complete revolutions tablets were re-weighed (W). The percentage friability was calculated by using formula.

                                I - W

Friability (%) =------------------ X 100

                                      I                

 

Percentage friability of the tablets less than 1% is in acceptable limits.

 

In-vitro tablet disintegration time test:

Tablet disintegration test used to determine the disintegration time of the tablet. Disintegration test were done for the prepared formulation of fast dissolving tablets using the USP disintegration test apparatus, the basket rack assembly containing six open ended tube and #10 mesh screen at the bottom was used. In this test tablet was placed in each of the six hollow tubes of the apparatus and one disc was added to the each tube. The basket filled with buffer solution instead of water in order to mimics the environment as much as possible. In this test time taken in seconds for check complete disintegration of the tablet. At the end of test there should be no residue remaining on the mesh of the tube.

 

Drug content:

The content uniformity of the fast dissolving tablet formulation was performed by taking 10 tablets from the each formulated batch and then equivalent to 1 tablet weight added to volumetric flask and sonicated for 30 min. Volumetric flask stands for 24 hrs at after that appropriate dilutions were made with methanol which is the solvent in the validated method and assayed by using UV visual spectrophotometer according to the Indian pharmacopoeia amount of the ingredient should be lies in the range of 92-110%

 

In-vitro dissolution study:

In vitro dissolution study were perform for the F1, F2, F3, F4, F5, F6, F7, F8, F9 and marketed tablet. USP dissolution test apparatus to (DS8000, Lavinda, Mumbai, India) use to the particular study at 50rpm, and 900ml of 0.1N HCL was added as a dissolution medium. Temperature of the medium was maintained at 37±0.5˚C. 10ml of aliquot of the dissolution medium was withdrawn at the set time interval absorbtion measured by UV spectrophotometer (3000+, Lavinda, Mumbai) at the filter solution the percent release of the drug was determine using standard curve and drug content. Dissolution rate studied for the prepared formulation and marketed tablet.

 

RESULT AND DISCUSSION:

Pre-formulation:

Physical characteristics of extracts:

Ginger extract: Extract was observed light brown in colour, aromatic in taste and pungent in odour. Cinnamon extract: Extract was observed dull yellowish brown in colour, fragrant in odour and aromatic in taste. Turmeric extract: Extract was observed yellow in colour, characteristics in odour and slightly bitter in taste. Long pepper extract: Extract was observed dark blackish brown in colour, aromatic in odour and hot and pungent in taste. Punarnava extract: Extract was observed light yellowish brown in colour, odourless and sweet, pungent and astringent in taste.

 

Melting point:

The determined melting point of all five extracts was found as Ginger extract at 46˚C, Cinnamon extract at 172˚C, Turmeric extract at 180˚C, Long pepper extract at 126˚C and Punarnava extract at 160˚C. It is reported that all extracts having variable point.

 

Solubility:

The solubility of the extracts was determined in different solvent systems. List of solvents which were used given in the table. Extracts is more soluble in acetonitrile and soluble in water, methanol. Solubility of extracts in each solvent is given in table 1.


 

Table 1: Solubility study of extracts in different solvents.

Sr. No.

Solvent

Solubility term

Ginger

Turmeric

Cinnamon

L.pepper

Punarnava

1.

Water

Soluble

Soluble

Soluble

Soluble

Soluble

2.

Methanol

Soluble

Soluble

Soluble

Soluble

Soluble

3.

Acetonitrile

F. Soluble

F. Soluble

F. Soluble

F. Soluble

F. Soluble

4.

PBS 7.4 pH

Soluble

Soluble

Soluble

Soluble

Soluble

5.

Ethanol

S. Soluble

S. Soluble

S. Soluble

S. Soluble

S. Soluble

F. Soluble = Freely Soluble S. Soluble = Sparingly Soluble

 


Fourier Transform Infrared Spectroscopy (FTIR):

FTIR spectra of extracts:

FTIR study was carried out to determine the various functional groups present in the drug molecule i.e. extracts and which is also act as a fingerprint of the molecule. Tables show the standard value of functional groups. Fig. 1, 2, 3, 4 and 5 shows the FTIR spectra of extracts.


 

 

Fig 1: FTIR spectra of Zingiber officinale extract.

 


Table 2: Infrared spectral band of Zingiber officinale extract.

Sr. No.

Functional group

Theoretical peaks (cm-1)

Practical peaks (cm1)

1.

C-H (stretch)

3000-2850

2927.1, 2854.77

2.

C-O (stretch)

1300-1000

1031.96

3.

C=O (stretch)

1900-1600

1653.07

4.

N-H (stretch)

3500-3100

3392.93

5.

O-H (stretch)

3700-3000

3675.52

6.

C=C (stretch)

1610 and 1475

1517.08

 

Fig 2: FTIR spectra of Curcuma longa extracts.

 

Table 3: Infrared spectral band of Curcuma longa extract.

Sr. No.

Functional group

Theoretical peaks (cm-1)

Practical peaks (cm-1)

1.

C-H (Aromatic)

3150-3050

3057.3, 3143.14

2.

C-O

1300-1000

1027.14

3.

C=O (Ketone)

1725-1705

1706.11, 1714.76

4.

O-H

3400-3200

3355.32

5.

C=C (Aromatic)

1600 and 1475

1513.22

 

Fig 3: FTIR spectra of Cinnamonum Zeylanicum extract.

 

Table 4: Infrared spectral band of Cinnamonum Zeylanicum extract.

Sr. No.

Functional group

Theoretical peaks (cm-1)

Practical peaks (cm-1)

1.

C-H (Aromatic)

3150-3050

3056.34, 3145.07

2.

C-O (Ether)

1300-1000

1056.07, 1195.85

3.

O-H

3400-3200

3291.67, 3382.34

4.

C=C (Aromatic)

1600 and 1475

1533.47

 

Fig 4: FTIR spectra of Piper longum extract.

 

Table 5: Infrared spectral band of Piper longum extract.

Sr. No.

Functional group

Theoretical peaks (cm-1)

Practical peaks (cm-1)

1.

C-H (Bend)

3100-3050

3079.49, 3096.85

2.

C-O (Stretch)

1300-1000

1080.18, 1194.95

3.

N-H (Stretch)

3500-3100

3446.94

4.

C=O

1740-1720

1734.08

5.

C=C (Stretch)

1600 and 1475

1491.04, 1585.55

 

 

Fig 5: FTIR spectra of Boerhaavia diffussa extract.

 

Table 6: Infrared spectral band of Boerhaavia diffussa extract.

Sr. No.

Functional group

Theoretical peaks (cm-1)

Practical peaks (cm-1)

1.

C-H (Aromatic)

3150-3050

3056.34, 3096.85

2.

C=O (Ketone)

1725-1705

1706.11,1714.76

3.

C=C

1600 and 1475

1616.42, 1595.2

4.

O-H

3400-3200

3292.63, 3392.93

5.

C-O (Ether)

1300-1000

1026.17, 1192.06

 

FTIR spectrum of SSG with all extracts:

 

Fig 6: FTIR spectra of Zingiber officinale extract with SSG.

 

Fig 7: FTIR spectra of Curcuma longa extract with SSG.

 

 

Fig 8: FTIR spectra of Cinnamonum Zeylanicum extract with SSG.

 

 

Fig 9: FTIR spectra of Piper longum extract with SSG.

 

 

Fig 10: FTIR spectra of Boerhaavia diffusa extract with SSG.

 

Powder blend characterization study:

Angle of repose:

The angle of repose (θ) was calculated in order to know the flow characteristics of the powder. The values of angle of repose for all formulated batch range between 15.52±0.16 to 17.01±0.12, indicating good flow of the powder blend. The powder mass of the different formulations were found to be non-aggregating. Angle of repose of each formulated batches given in table 7.

 

Loose bulk density:

Bulk density tells us that space occupied by the bulk powder. The results of bulk density are represented in table 3.7. The bulk density of all formulated batches was observed in between 0.332±0.21 gm/ml to 0.487±0.31 gm/ml.

 

Tapped density:

The results of tapped density shown in table 3.7. The tapped density was observed in between 0.489±0.17 gm/ml to 0.620±0.13 gm/ml. the difference in densities indicates very less in powder volume each after 100 tapping and had almost same flow properties.

 

Hausner’s ratio:

The hausner’s ratio of all formulation was in the range of 1.269±0.02 to 1.514±0.01 shown in the table 7.

 

Carr’s consolidation index:

In the present study, the carr’s compressibility index was found to be in between 11.51±2.80 to 22.28±1.50%.


Table 7: Evaluation of powder blend.

Batch

Bulk Density

Tapped Density

Carr’s Index

Hausner’s Ratio

Angle of Repose

(gm/ml)

(gm/ml)

(%)

(˚)

F1

0.375±0.22

0.535±0.16

16.59±2.85

1.426±0.05

16.30±0.15

F2

0.408±0.32

0.525±0.15

22.28±1.50

1.305±0.06

15.52±0.17

F3

0.332±0.21

0.489±0.17

18.99±2.50

1.472±0.05

16.69±0.11

F4

0.335±0.22

0.484±0.15

20.81±1.67

1.444±0.04

16.81±0.16

F5

0.416±0.21

0.590±0.18

11.51±2.80

1.418±0.06

16.90±0.18

F6

0.321±0.32

0.469±0.20

21.54±3.22

1.448±0.02

17.01±0.12

F7

0.436±0.22

0.582±0.12

16.71±2.34

1.334±0.01

16.69±0.14

F8

0.457±0.31

0.620±0.13

11.70±2.65

1.356±0.06

16.03±0.17

F9

0.342±0.23

0.518±0.16

14.22±2.10

1.514±0.01

16.80±0.11

Mean ± SD (n=3)


 

Evaluation of fast dissolving tablets:

Appearance:

All the formulated tablets (F1-F9) were yellowish brown in color and biconcave in shape. Tablets had a smooth surface.

 

Uniformity of weight:

Tablet uniformity was in acceptable range all formulations pass the uniformity of weight test. The results were within the acceptance limit as per the Indian Pharmacopoeia.

 

Hardness:

Hardness refers to the how much strength tablet contains. The hardness of tablet found to be in between 4.10±0.22 to 4.90±0.11kg/cm2. FDT has less hardness then the conventional tablets hardness of each formulated batches given in the table 8.

 

Thickness:

The thickness of the all prepared formulations found in the range 3.1±0.06 to 3.9±0.02 mm. the prepared batches of the FDT were not varying and they having minor deviation. Thickness of each formulated batches given in the table 8.

 

Friability:

Friability of all formulated FDT was found to be in the range of 0.255±0.01 to 0.862±0.03%. In all the formulation were in limits. Results suggest all formulations have good mechanical strength and they are well in handling and transportations. Friability of each formulated batches given in the table 8.

 

In-vitro disintegration test:

Disintegration time was found in the range of 10±0.32 to 22±0.46 seconds. On the basis of best disintegration time among all formulation selected for further comparison study with marketed conventional formulation. Disintegration time is shown in the table 8.

 

Drug content:

Drug content evaluated for each of formulation shown in table 8. All prepared formulation having drug content within the range 98.60±0.40 to 100.70±0.33.


 

Table 8: Evaluation of Tablet.

Batch

Hardness

Thickness variation

Weight

Friability

Disintegration time

Drug content

(kg/cm2)

(mm2)

(%)

(%)

(sec)

(sec)

F1

4.40±0.21

3.6±0.05

1.06±0.02

0.862±0.03

12±0.47

100.30±0.32

F2

4.90±0.11

3.9±0.02

1.02±0.04

0.255±0.01

18±0.32

98.60±0.40

F3

4.10±0.22

3.1±0.06

1.55±0.01

0.50±0.02

12±0.41

100.45±0.35

F4

4.90±0.12

3.7±0.04

1.012±0.03

0.34±0.01

25±0.31

98.80±0.31

F5

4.29±0.21

3.6±0.03

1.050±0.01

0.851±0.03

22±0.45

98.65±0.28

F6

4.11±0.11

3.4±0.03

1.018±0.05

0.255±0.02

17±0.35

99.45±0.22

F7

4.20±0.22

3.4±0.02

1.51±0.02

0.593±0.01

20±0.33

98.60±0.49

F8

4.16±0.21

3.5±0.08

1.020±0.04

0.343±0.0

18±0.41

98.95±0.57

F9

4.30±0.11

3.6±0.05

1.60±0.03

0.672±0.04

22±0.37

98.70±0.27

 

 

Fig 11: Graphical representation of disintegration time of the formulations F1 to F9.

 

Fig 12: Graphical representation of drug content of the formulation F1 to F9.

 


In-vitro dissolution:

All formulations F1 to F9 on the basis of the disintegration time in order to compare the drug release pattern were selected. We have found that 85% drug released from FDT in 30 minutes which shows that they rapidly releasing the drug and 100% drug release in 50 minutes. Drug release pattern is given in the table 9 and also shown in fig. 13.


 

Table 9: Drug release profile of F1 to F9.

Time

F1

F2

F3

F4

F5

F6

F7

F8

F9

MF        

(min)

%CDR

%CDR

%CDR

%CDR

%CDR

%CDR

%CDR

%CDR

%CDR

%CDR

0

0

0

0

0

0

0

0

0

0

0

2

0.90

1.14

1.26

1.52

2.44

1.98

0.98

1.92

2.00

0.76

4

9.90

20.21

13.27

12.22

15.38

12.01

13.04

13.01

11.37

6.98

6

30.44

32.03

32.65

38.12

35.20

35.97

37.04

35.97

35.54

16.22

8

42.53

47.25

43.36

44.09

46.15

42.26

47.80

42.26

45.25

28.07

10

55.06

55.70

60.29

59.36

61.08

59.68

62.077

59.68

60.02

37.10

15

67.71

68.71

72.59

68.75

73.25

68.97

71.46

68.97

69.38

49.96

20

76.92

74.06

77.01

75.24

77.90

75.61

76.58

75.61

76.54

58.61

25

81.63

78.86

82.05

80.41

84.21

80.97

82.12

80.97

80.24

65.42

30

85.28

86.34

87.69

85.24

85.20

85.06

86.28

85.06

85.99

71.68

40

91.90

90.14

91.86

90.23

92.44

91.05

92.94

91.94

90.23

77.90

50

97.07

95.94

94.81

94.62

96.19

98.44

99.01

98.19

97.04

82.16

 


 

Fig 13: Drug release profile of formulations F1 to F9 and comparison with marketed formulation.

 

ACKNOWLEDGMENT:

The authors are thankful to the Dr. M. S Ashawat, Principal of Laureate Institute of Pharmacy, Kangra and Himachal Pradesh Technical University Hamirpur and also Combatore for providing laboratory facilities and encouragement to do this research work. This research was supported/partially supported by department of pharmacy, Himachal Pradesh Technical University, Hamirpur and my supervisors. I would also like to thank my friends and family who supported me and offered deep insight into the study.

 

CONCLUSION:

Administration of herbal drug using fast dissolving tablets has excellent fast release in body. It also helps in improving the bioavailability of the drugs. Oral route has been one of the most popular routes of drug delivery due to its ease of administration, patience compliance, least sterility constraints and flexible design of dosage forms. Ginger, Cinnamon, Turmeric, Long pepper and Punarnava are the useful for the health. A nutraceutical is “any non-toxic food component that has scientifically proven health benefits, including disease treatment or prevention.” Herbal tablet of ginger, cinnamon, turmeric, long pepper and punarnava combination of available in the conventional tablet dosage form. It having the problems in absorption from GIT and hence its bioavailability is about 20% only. In order to improve its bioavailability fast dissolving tablets formulated using suitable excipients. Hence it is aimed to design a fast release tablets by using various superdisintegrants in variable concentrations. superdisintegrants crospovidone, CCS, SSG were used to formulate the fast dissolving tablets, MCC and Lactose were used as diluents in FDT formulations. All evaluation parameters of FDT performed. On the basis of best disintegration time of the commonly used superdisintegrants SSG shows the best results in 10% concentration. We have carried out in-vitro comparison for the all formulations F1 to F9 (it is the combination of all extract formulations.

 

REFERENCES:

1.      Meulenbeld, Gerrit Jan. “Introduction”. A History of Indian Medicinal Literature. Groningen: Egbert Forsten 1999.

2.      Smith, Frederick M., Wujastyk, Dagmar. “Introduction”. In Smith, Frederick M.; Wujastyk, Dagmar. Modern and Global Ayurveda: Pluralism and Paradigms. New York 2008. pp 1-28.

3.      “A closer look at Ayurvedic Medicine” Focus on complementary and Alternative Medicine. Betheesda, Maryland: National Center for Complementary and Integrative Health (NCCIH). US National Institutees of Health (NIH). 2006: 12(4).

4.      Anil Joy Pulikkottil. History of Ayurveda. Encyclopedia of Ayurvedic Medicinal Plants: A Candle for Medicinal Herb’s Identification; 2012.

5.      Agence France-Presse.” Indian state steps up hunt for mythical glow-in-the dark plant”. The Guardian: 2016.

6.      Sunitha HS, Parthiban S, Kumar GS, Mani TT, Recent review on the technological advancement and the use of natural superdisintegrants in the formulation of fast disintegrating tablet. Asian Journal of Research in Pharmaceutical Sciences and Biotechnology. 2014; 2(2): 31-37.

7.      Ghiware Nitin B, Gattani Surendra G. Designs, development and evaluation of herbal formulationof piper nigram and N. tanthis asbortristis, Int J. Pharma Tech Res. 2010, 2(1), 171-176.

8.      Upendra Kulkarni, Prasant a Borgaonkar, Basawaraj S. Patil, Prakash G. Korwar. Formulation and Development of fast disintegrating tablets containing fenugreek seed powder. Asian Journal of Pharmaceutical and Clinical Research vol. 4, issue1, 2011, 87-89.

9.      Upendra Nagaich, Ashok kumar Pal, Charu Bharti, Neha Gulati. Formulation and evaluation of neutracuetical tablet using herbal drugs by direct compression method, Journal of Drug Delivry and Therapeutics 2014, 4(2) 47-51.

10.   Amrita A. Kagulkar, Sachin A. Nitave; Development and Evaluation of Bauhenia veriagata Linn mixture: International Journal of Pharmatech Research 2014, 6(5). 1600-1607.

11.   Samuelson G. Drugs of natural origin: A textbook of pharmacognosy, 4th edition, Stockholm, Swedish Pharmaceutical press 1999; 5-7.

12.   Sobhanizadeh Ali and Yadegari Hoshang. Introduction on application of herbal medicine. The 1st Annual Iranian Agriculture Research Conference 2015; 1-11.

13.   Kokate CK, Purohit AP, Gokhale SB. Pharmacognosy. 39th edition pune: Nirali Prakashan; 2007.

14.   Indian Pharmacopoeia. Ghaziabad: The Indian Pharmacopoeia Commission; 2007. pp 136-188.

15.   Merck research Laboratories. The merck index; 2006: pp 1428.

16.   Singh Rudra Pratap and Gangadharappa H V. ginger: A potential Neutraceutical, An Updated Review. International Journal of Pharmacognosy and Phytochemical Research 2017; 9(9); 1227-1238.

17.   Margret Chandira, B. Jayakar. Formulation and evaluation of herbal tablets containing Ipomoea digitata Linn. Extract; International Journal of Pharmaceutical Sciences Review and research 2010; 3(1): 101=110.

18.   Aulton ME. Pharmaceutics the Science of Dosage Design. Churchill Livingstone. Second Edition. 2002; 134.

19.   R.V. Hirave and M.S. Kodawar. Development and evaluation of herbal fast dissolving tablet of Capparis divaricata Lam; International Journal of Advance in Pharmaceutics 2017; 6: 24-30.

20.   Monton C H, Saingam W O and Sakunpak A P. Formulation development and physical properties study of Thai traditional herbal tablets: original Jit-Tra-Rom reciepe. International Journal of Pharmacy Science 2014; 6: 611-614.

21.   VB Krishansagar and UA Deokate. HPTLC Method development and validation for the stimulaneous estimation of Diosgenin and lepodopa in marketed formulation; Asian Journal of Research in Chemistry; 1(1); 2008: 36-39.

22.   Ismail and R. Rajavel. RP- HPLC method for the simultaneous determination of aspirin, Atorvastatin and pioglitazone in capsule dosage form. Asian Journal of Research in Chemistry; 1(1); 2008: 40-42.

23.   SS Chitlange and Kiran Bagri. Stability indicating RP-HPLC method for simultaneous estimation of valsaucan and amlodipine in capsule formation. Asian Journal of Research in Chemistry; 1(1); 2008: 15-18.

24.   Nilesh Jain and Ruchi Jain. RP-HPLC method for simultaneous estimation of simvastatin and ezetimibe in bulk drug and its combine dosage form. Asian Journal of Research in Chemistry; 1(1); 2008: 29-31.

25.   P. Nagaraju and K Krishna chaithanya. Reverse phase HPLC method for determination of ethamsytale in bulk and tablet dosage form. Asian Journal of Research in Chemistry; 1(2); 2008: 88-90.

26.   J Baghayalakshmi and S Vijayraj. Method development and validation of erythromycin (E127) using RP-HPLC coupled with PDA detector. Asian Joural of Research in Chemistry; 1(2); 2008: 95-96.

27.   RB Kakde and V H Kotak. Estimation of bisoprolol fumarate in pharmaceutical preparations by HPTLC. Asian Journal of Research in Chemistry; 1(2); 2008: 70-73.

28.   R Siva Kumar and P. Kumar Nallasivan. Simultaneous RP-HPLC estimation of nitazoxanide and oflaxacine in tablet dosage form. Asian Journal of Research in Chemistry; 1(1); 2009: 43-45.

29.   Prasanna Reddy Batty and MS Reddy. Development and validation of RP-HPLC for the rabeprazole sodium in pharmaceutical formation and human plasma. Asian Jouranal of Research in Chemistry; 2009; 2(1): 49-51.

30.   V. Kiran Kumar and N Attala Raju. The estimation of irinotecan. HCl in parenterals by RP-HPLC. Asian Journal of Research in Chemistry; 2008; 2(1): 54-56.

31.   Mukul Ahmed and Ravi kumar. Formulation and evaluation of fast dissolving tablet of DoxazosinMesylate. Asian Journal of Pharmaceutical Research 2016; 6(3): 131-146.

32.   Injanamul Haque and Ravi Kumar. Formulation and evaluation of MontalukastSodium fast dissolving tablets. Asian Journal of Pharmaceutical Research 2016; 6(3): 159-169.

33.   Satish Shinde and Dharmendra Mundhada. Formulation and evaluation of fast dissolving tablet of drug used in treatment of motion sickness. Asian Journal of Research in Pharmacuetical Science 2015; 5(3): 181-187.

34.   Rebecca and Ravi Kumar. Formulation and evaluation of mouth dissolving tablet of labetalol HCL by sublimation method. Asian Journal of Pharmacy and Technology 2016; 6(2): 70-80.

35.   Neha Srivastava and Seema Thakur. Fast dissolving tablet: A novel in the drug delivery system. Asian Journal of Pharmacy and Technology 2016; 6(3): 148-154.

36.   RautIndrayani D and Garge Manisha. Formulation and characterization of fast dissolving tablet of Perindopril. Asian Journal of Pharmacy and Technology 2017; 7(1): 51-55.

37.   Yogita Rayate and Shrinivas Mohite. Formulation and evaluation of fast dissolving tablet of Pioglitazone. Asian Journal of Pharmacy and Technology 2019; 9(1): 23-26.

38.   Ratna Shelke and Jagdish Bharad. Adsorption of Nickel (II), Copper (II) and Iron (II)of Kammoni leaf powder: A case study. Asian Journal of Research in Chemistry 2011; 4(1): 100-103.

39.   Ajay Kumar Meena and Ch. V. Narashimaji. Comparative Preliminary Phytochemical and HPTLC Fingerprinting profile studies of two cinnamon species commonly used in ASU formulations. Asian Journal of Research in Chemistry 2018; 11(2): 344-350.

40.   Sona Tyagi and Tanveer Alam. Biosynthesis of silver nanoparticles using Medicinal plant Anacycluspyrethrum and its antibacterial Efficacy. Asian Journal of Research in Chemistry 2018; 11(3): 515-520.

 

 

 

 

Received on 22.04.2020            Revised on 20.05.2020             

Accepted on 17.06.2020      ©Asian Pharma Press All Right Reserved

Asian J. Pharm. Tech.  2020; 10(4):231-240.

DOI: 10.5958/2231-5713.2020.00039.2