Formulation and Evaluation of Anti-Diabetic Tablet from Insulin plant (Costus igneus)

 

Khushi B. Khalkar1*, Kaweri K. Chaudhari2, Gitanjali N. Gaikwad3

1Student, Rashtrasant Janardhan Swami College of Pharmacy, Kokamthan, Ahmednagar, Maharashtra – 414001.

2Assistant Professor, Rashtrasant Janardhan Swami College of Pharmacy,

Kokamthan, Ahmednagar, Maharashtra – 414001.

3Student, Rashrasant Janardhan Swami College of Pharmacy, Kokamthan,

Ahmednagar, Maharashtra – 414001.

*Corresponding Author E-mail:

 

 

Abstract:

Native to Southeast Asia, Costus igneus, sometimes known as the insulin plant, is a traditionally utilized medicinal herb. The member of the costaceae family Chamaecostus cuspidatus, also referred to as flaming costus. The plant is cultivated as an attractive plant in south India and was only recently brought to the country. Numerous phytochemical components, including steroids, alkaloids, flavonoids, triterpenes, glycosides, and saponins, are found in insulin plants. As a food supplement, its leaves are used to treat diabetes mellitus. "A leaf a day keeps diabetes away" is the plant's slogan. Antidiabetic effect, antiproliferative potential, antibacterial action, anti-inflammatory potential, and antioxidant activity are the diverse pharmacological effects. This plant's leaf, which is often known as, strengthens the beta cells in the pancreas, which helps the body to produce more insulin hence referred to as “insulin plant” in India.

 

KEYWORDS: Costus igneus, Insulin plant, Spiral flag, Antidiabetic activity, Fiery costus.

 

 


INTRODUCTION:

 

Fig. 1: Insulin plant

 

Costus igneus usually known as fiery Costus, Step ladder or Spiral flag or Insulin plant, is natural to South India. This is a recent introduction to India as an herbal cure for diabetes and hence frequently called as ‘insulin plant’. It is used in India to control diabetes, and it is known that diabetic people eat one leaf daily to retain their blood glucose low.

 

One plant that has been known to be effective in treating diabetes is Costus igneus leaves. The main flavonoid identified from the Costus igenus ethanol extract is quercetin. It reduces hyperglycemia and increases cellular absorption of glucose. It has been discovered that several phytoconstituents, including ascorbic acid, alpha-tocopherol, beta-carotene, terpenoids, steroids, and flavonoids, have antioxidant activity.

 

Because its leaves aid in the synthesis of insulin in the human body, Costus igneus a member of the Costaceae family, is sometimes referred to as the "insulin plant" in India. There is an increasing need for herbal medicines to treat diabetes mellitus because oral hypoglycemic medications have a number of side effects. Traditional medical practices and folklore both employ a variety of plant to treat diabetes mellitus.

 

Future research on novel oral hypoglycemic substances derived from medicinal plants will be significant for the creation of pharmaceutical products or as a dietary supplement to current treatments. One such traditional plant that is currently gaining popularity throughout the world and being utilized extensively as an ayurvedic medicinal herb is the insulin plant. Blood glucose levels are thought to be lowered by consuming the leaves of this plant; who has report experiencing a drop in blood sugar. It is a relatively new plant in India, and Kerala is where it is planted as an ornamental.

 

In the Ayurvedic system of medicine, diabetes is traditionally treated by chewing the plant leaves for a period of one month to get a controlled blood glucose level. Insulin Plant Costus igneus is a perennial, upright, tropical evergreen plant belongs to the family Costaceae. Possesses evergreen leaves which are simple, alternate, entire and oblong, having 4-8 inches length with parallel venation. The large, smooth, dark greens leaves possess light purple undersides and are spirally arranged around stems, forming attractive, arching clumps arising from underground rootstocks. It reaches a height of about 60cm with the tallest stems falling over and lying on the ground. Beautiful orange flowers are produced in the warm months having a 2.5-12.5cm diameter, appears on cone-like heads at the tips of branches. Common names: Fiery Costus, Spiral flag, Insulin plant, This plant belongs to the family costaceae which was first raised to the rank of family by Nakai on the basis of spirally arranged leaves and Rhizome being free from aromatic essential oils. This family consists of 4 genera and approximately 200 species. The genus costus is the largest family because it is having 150 species.

 

These plants produce a wide range of chemical substances that are essential for plant defense against both biotic and abiotic stressors. It has been found that several phytochemicals have potential pharmacological and biological effects.

 

The different synonyms of this plant are Costuscusoidatus, Costusigneus, Globbacuspidatus Costus pictus. It is native to primary Atlantic rainforests, deep shade in south eastern Brazil. The geographical distribution is varied seasonally dry forest of south west Amazonia.

 

It consist of eight major species of genus Chamaecostus i.e. C. cuspidatus, C. subsessilis, C. lanceolatus, C. congestiflorus, C. fragilis, C. curcumoides, C. fusiformis, C. acaulis.7.

 

Medicinaluse:

The most abundant bioresource of pharmaceutical intermediates, modern medications, folk remedies, nutraceuticals, nutritional supplements, and chemical components for synthetic drugs is medicinal plants.

 

Bioactive compounds:

It is commonly known that the seeds, leaves, and stem bark of several plant species contain bioactive substances like amides, alkaloids, flavonoids, tannins, saponins, glycosides, terpenoids, and phenolic compounds.

 

Triterpenoids:

Tri-terpenoids primarily work by preventing the activity of alpha-glucosidase and alpha-amylase, which slows down the intestinal absorption of carbohydrates and lowers postprandial insulin levels. It results in insulin resistance, glucose metabolism, insulin levels, and plasma glucose normalization. Oleanolic and ursolic acid, two well-known triterpenes, exhibit efficacy against diabetic complications; this may be because they affect the expression of SDH (succinate dehydrogenase) and aldose reductase.

 

Aldose reductase is responsible for the suppression, and SDH reduces endogenous AGE (Advanced glycation end products) production and carbonyl stress, which are linked to the development of diabetes problems. Ursolic acid improves the insulin receptor and decreases the production of DGAT (Diacylglycerol acyltransferases) in proteins, which may also contribute to the deposition of triglycerides in the liver. Corosolic acid aids in the absorption of glucose. However, research from many sources indicates that Costus igneus has a very little amount of corosolic acid

 

Steroids:

Steroids are synthetic form of hormones, which are naturally occurring substances in the human body. Steroids are intended to lessen inflammation by functioning similarly to these hormones. In the liver of diabetic rats, steroids such as diosgenin reduce the activity of enzymes linked to diabetes, including pyruvate kinase, glucose-6-phosphate dehydrogenase, and ATP-cytrate lyase. In diabetic rats, diosgenin effectively lowers plasma glucose levels. By encouraging adipocyte differentiation and reducing inflammation in adipose tissues, it may help treat diabetes. Therefore, improving the patients condition in the glucose metabolic disease linked to obesity might be beneficial.

 

Flavonoids:

Plants are abundant in flavonoids, a class of secondary metabolites whose molecular structure is defined by a variety of phenolic compounds. Numerous flavonoids have been shown to have anticancer properties. Quercetin is one flavonoid that raises the activity of the enzyme that limits the pace of glycogen production. Additionally, it decreases intestinal glucose absorption by blocking GLUT2 and raises antioxidant enzymes such as SOD, GPX, CAT, etc. Quercetin is said to help prevent diabetes by inhibiting tyrosine kinase. Additional roles of flavonoids include increasing insulin secretion through the regeneration of pancreatic β-cells, improving insulin-mediated glucose uptake by target cells, inhibiting aldose reductase, increasing calcium uptake, and more. Costus igneus has a high concentration of flavonoids.

 

CLASSIFICATION:

Domain: Eukaryota

Kingdom: Plantae

Subkingdom: Viridaeplantae

Phylum: Tracheophyta

Subphylum: Euphyllophytina

Class: Liliopsida

Subclass: Commelinidae

Order: Zingiberales

Family: Costaceae

Genus; Chamaecostus

Species: cuspidatus

 

Anti-diabetic effect:

In south Indian gardens, Costus igneus is a widely spread attractive plant and a widely used medicinal plant. The component that has the strongest antidiabetic effect is the leaves. It reduces fasting as well as postprandial blood glucose levels. Quercetin is the major flavonoid isolated from the ethanolic extract of Costus igneus plant.

 

Along with its antidiabetic activity, insulin plants also reduce the complications associated with diabetes: they bring renal and hepatic parameters under control, decrease glycosylated hemoglobin levels, correct the lipid profile, increase body weight and insulin levels, and exhibit a significant improvement in the histopathological examination.1

 

Antioxidant effect:

DPPH, β-carotene, Deoxyribose, superoxide anion, reducing power, and metal chelating test were among the models used to evaluate the antioxidant properties of leaves and rhizomes in methanol, water, ethanol, and ethyl acetate extracts at varying concentrations. At 400μg/ml, C. pictus leaves and rhizomes had good antioxidant activity, measuring roughly 89.5% and 90.0% in comparison to conventional BHT (Butylated Hydroxy Toluene) (85%). The outcomes showed that, in comparison to other extracts, the methanolic extracts of C. pictus's leaves and rhizomes had more antioxidant activity.  Methanolic extracts of flower and stem of C. pictus possess in vitro antioxidant action against oxidative protein damage.

It was obvious from the study that the polyphenols and antioxidants not only scavenge off the free radicals but also inhibits the formation of the free radical.1

 

Antimicrobial Effect:

Methanol extracts from the stem and root of Costus igneus exhibited weak to moderate efficacy against the majority of the bacteria that were tested. The methanol extract of the root demonstrated strong activity against Klebsiella oxytoca, Pseudomonas fragi, and Enterobacter aerogens, and the agar diffusion assay was used to observe the antimicrobial activity of the plates in comparison to those of "Gentamycin," a standard antibiotic. Maximum antibacterial activity against gram-positive strains of Bacillus cerus, Bacillus megaterium, Micrococcus leuteus, Staphylococcus aureus, Streptococcus lactis, and gram-negative germs was demonstrated by the methanolic extract of C. igneus. Pseudomonas aeruginosa, Escherichia coli, Salmonella typhimurium, Enterobacter aerogenes, and Klebsiella pneumoniae. Of the Costus pictus extracts, the methanolic extracts of the stem and flower showed the greatest inhibitory activity at 150μg/ml on the growth of the microbes that were tested, namely Shigella flexneri, Klebsiella pneumonia, Bacillus subtilis, and Escherichia coli. A moderate level of antibacterial and antifungal activity was demonstrated by the isolated chemical derived from the ethanolic extract of Costus igneus against Staphylococcus aureus, Escherichia coli, and Candida albicans.1

 

The disc diffusion method:

The principle in regular clinical bacteriology, the disc diffusion method offers a quick and accurate way to determine how a certain drug affects a particular bacterium. This technique involves impregnating tiny circular discs of regular filter paper with a specified quantity of a material at a selected concentration. The discs are put on culture medium plates that have been previously smeared with the test bacterial inoculum. Following incubation, the inhibition zone created by the antibiotics' diffusion from the discs into the surrounding medium is measured to ascertain the degree of sensitivity.

 

Procedure:

Whatman No. 1 filter paper was used to create round discs with a 6mm diameter, which were then autoclave sterilized. Every paper disc was put on nutrient agar plates that had been seeded with the test bacterium after being impregnated (soak) with 0.2mL of the test substance (leaf extract) in the corresponding solvent for the entire night. For twenty-four hours, the plates were incubated at 37°C. The zone of inhibition surrounding each disc was measured and noted after a 24hour period. To make sure the results were reliable, each extract was tested three times. The reference (positive control) was 30 g/disc of chloramphenicol. Only the extraction solvent was employed to create a negative control (Rosoanaivo and Ratsimamanga-Urverge, 1993).

 

Anti-Proliferative Potential:

The anti-proliferative and apoptotic effects of a methanolic extract of powdered leaves from Costus igneus (MECiL) were assessed by Prof. S. Dhanasekaran et al. (2014) on the in vitro MCF 7 (Michigan Cancer Foundation-7) breast cancer cell line. Without harming the normal cells, the extract (MECiL) was able to shrink the tumor. Using the MTT (3- (4, 5-dimethyl thiazol-2-yl)-2, 5-diphenyl tetrazolium bromide) test, the cytotoxicity and cell viability of the provided extract (15–2000µg/ml) were also assessed on the L6 (Rat skeletal muscle cell line). The extract's IC 50 value (half maximal inhibitory concentration) was 2000µg/ml. The extract demonstrated cytotoxicity aligned with the normal cell lines only at extremely high concentration, but it wasn’t apoptotic to the regular cell lines.

 

The extract demonstrated strong anticancer activity at the maximal doseof 2000µg/ml, or 97.46±0.74 percentage cytotoxicity. The extract possessed dose-dependent cytotoxicity against the MCF-7 cell line11.1

 

Anti-Inflammatory Potential:

In their 2014 study, Kripa Krishnan et al. used an in vitro model with LPS-induced human peripheral blood mononuclear cells (hPBMCs) and a carrageenan-induced rat model to investigate the anti-inflammatory properties of β-amyrin extracted from the leaves of Costus igneus (C. igneus). The greatest percentage suppression of paw edema at a particular dose of 100mg/kg body weight was found using the differential fractionation methanolic extract (MEC) of leaves from Costus igneus. Several solvents, including butanol, hexane, ethyl acetate, and chloroform, were used in the fractionation of MEC. At a dose of 50mg/kg body weight, the chloroform extract (CEC) of MEC had the greatest positive impact.

 

CEC treatment of rats given carrageenan Compared to rats given carrageenan, there was a significant decrease in the activities of cyclooxygenase (COX), lipoxygenase (LOX), myeloperoxidase (MPO), and nitric oxide synthase (NOS). The β-amyrin that was extracted from it demonstrated a dosage-dependent reduction in paw edema, and when given to rats at a dose of 100µg, it resulted in a 97% reduction in paw edema caused by carrageenan.1

 

ANATOMY OF LEAF:

The leaf is isobilateral, thin, and has smooth, flat surfaces with no distinction between the upper and lower sides. The leaf is composed of four layers of broad, tangentially oblong, thin-walled mesophyll cells and two layers of thin epidermal cells. The cells in both epidermal layers are 10–20 µm thick and have narrow, tangentially flat, thin walls. Mesophyll cells range in thickness from 100 to 140 µm. These conspicuous vascular bundles are situated in the lamina's middle region. The bundles are collateral, with a small cluster of phloem and a broad mass of xylem parts. There is a thick band of lignified sclerenchyma cells on the bundle's phloem end. The xylem components have thick, angular, and broad walls. There are no distinct bundle sheath cells in the vascular bundles.26.

 

Fig: 2 Leaves of insulin plant

 

Habit and Habitat:

The herbaceous plant Chamaecostus cuspidatus is tiny and non-aromatic. In its environment, it is caulescent. It thrives (grows) on stony soil that receives lots of moisture as well as big rock outcrops. It is commonly cultivated yet rare in the wild. Growth and propagation through clump division, pruning, or removing offsets or plantlets from beneath the flower head.

 

The Insulin Plant (Costus igneus) is indigenous to Southeast Asia, particularly the Indonesian Greater Sunda Islands. It is a relatively recent addition to India and Kerala. Large, fleshy-looking leaves are a defining characteristic of the plant. These big, smooth, dark-green leaves with pale purple underside accents. The leaves emerge from underground rootstocks in visually appealing, arching bunches that are spirally grouped around the stem. These plants can grow up to two feet in height. The pretty, 1.5-inch-diameter blossoms are orange in color. In warm months the flowers bloom. At the tips of branches, they also seem to resemble cone-shaped heads. The flower petals are nutrient-dense and delicious. It grows more slowly and is excellent for covering the ground. The Costus pulverulentus family is distinguished by its tall, crimson flower spikes. Costus igneus is a fast-growing plant. Stem cutting is how this plant is propagated. Although it prefers sunlight, it may also grow in places that are a little shaded. Diseases and pests are not an issue in Costus. Both indoor and outdoor plants may be impacted by red spider mites and caterpillars, respectively.6

 

Fig. 3: Flower of insulin plant

 

MATERIAL AND METHODS:

By Soxhlet extraction:

Preparation of Plant Extract:

1. The collected fresh leaves of Costus igneus are dried in shade for 1 week.

2. After drying plant material are coarsely powder and    kept in well close container.

3. About 20gm of powder of plant leaf is taken in soxhlet apparatus and extract with 100ml ethanol.

4. The extraction will be carried out for 8h at a room temperature of 30°C.

5. The collected extract is concentrated on water bath or rotary evaporator.2

 

Fig. 4: Soxhlet assembly

 

PHYTOCHEMICAL ANALYSIS:

a)   Test for tannins:

About 2 ml of extract were combined with a few drops of ferric chloride solution in 2 ml of distilled water. The formation of a precipitate with a green colour indicates the presence of tannins.

b) Test for saponins:

      3 ml of the extract and 3 ml of distilled water were combined in a test tube and shaken vigorously for few minutes. The presence of saponins is shown by the formation of a stable foam in the test tube after heating.

c)   Test for flavonoids:

In a test tube, 1 ml of extract was mixed with 1 ml of a 10% lead acetate solution. The presence of flavonoids can be determined by looking for the appearance of the yellow precipitate.

d) Test for alkaloids:

3ml of the extract and 3ml of 1% HCL were combined on a hot water bath. 1ml of the liquid was then divided between two test tubes. The first test tube received 1 mL of Dragendroff's reagent added to it. Orange-red precipitate was thought to be a positive indicator. The second test tube was filled with 1 ml of Mayer's reagent. Alkaloids can be identified by the precipitate forming a buff colour.

e)   Test for terpenoids:

2 mL extract was dissolved in a 2 mL CHCl3 solution and then dried off. Next 2 mL of concentrated sulfuric acid (H2SO4) was added, and the mixture was heated for approximately 2 minutes. Terpenoids are indicated by the appearance of a greyish colour.

f)   Test for steroids:

Salkowski's test and the Liebermann test were the two procedures used to determine the presence of steroids in the extract. The organic extract was dissolved in 2 ml of chloroform for the Salkowski test. To this, 2 mL of saturated H2So4 was added. The emergence of red colour in the chloroform section indicates the presence of steroids.

g)   Test for phenols:

1g of extract was mixed with 5ml of distilled water, and the mixture was then treated with a 5% ferric chloride solution. The development of a dark green color indicates the presence of phenols.

h) Test for reducing sugars:

Dilute HCl was used to acidify 1.0 ml of plant extract, and diluted NaOH was used to neutralize it. Fehling's A and B solutions were then used, heat the mixture. The red precipitate's emergence can indicate positive results.8.

PREFORMULATION STUDY:

1. Angle of repose:

The funnel method is used to calculate the angle of repose. The precisely weighed mixture was transferred into a funnel. It was decided to set the funnel height so that the tip of the funnel just touches the "head of blend" or "apex of the heap." Through the funnel “the drug excipient blend” was allowed to flow freely on to the surface. The link between Powder Flow and Angle of Repose is displayed in Table 1. The following formula was used to get the angle of repose and the diameter of the powder cone:2

 

Tan θ = h/r

Where,

h = height of powder cone formed

r = radius of powder cone formed

Flow property

Angle of repose

1.Excellent

25-30

2.Good

31-35

3.Fair

36-40

4.Passable

41-45

5.Poor

46-55

6.Very poor

56-65

7.Very very poor

>66

 

2. Bulk density:

By pouring a weighed quantity of blend into graduated cylinder and measuring the volume and weight of powder.

Bulk Density = Weight of powder/Bulk volume

 

3. Tapped density:

A known mass of drug excipient blend is placed in measuring cylinder. The cylinder is tapped on to a hard surface by giving 100 tappings. Tapping is continued, “until no further change in volume is noted”

Tapped Density = Weight of powder/Tapped volume

 

4. Compressibility index:

Compressibility index (%) = (Tapped density - Bulk density) x 100  

                                                         (Tapped density)

5. Hausners ratio:

Tapped density/ Bulk density

 

Procedure for Tablet Preparation:

1.   Weighing and Mixing: Weigh the required amounts of active pharmaceutical ingredient (API), excipients, and binder. Mix the ingredients in a suitable container using a spatula or mixer.

2.   Sieving: Sift the mixed powder through a 40-mesh sieve to ensure uniform particle size.

3.   Lubrication: Add the lubricant (e.g. magnesium stearate) and glidant to the powder and mix well.

4.   Compression:  Load the powder mixture into a tablet press. Set the compression parameters (e.g., compression force, tablet thickness). Compress the tablet at a rate of 10-30 tablets per minute.

5.   Ejection and Inspection: Eject the compressed tablets from the press. Inspect the tablets for defects (e.g., cracking, chipping).

6.   Packaging: Pack the tablets in suitable containers. (e.g., bottles, blister packs)2

 

PHYSICAL EVALUATION OF TABLETS:

1. Organoleptic properties:

It consist colour, taste, smell, and even shape and size. There must be no mottling and should have uniform dispersion of colour. Compare the sample's colour to the standard colour to see a visual comparison of colours. A batch of tablets that’s smell suggests that there may be a stability issue. One example of this would be the smell of acetic acid in aspirin tablets. The medicine (vitamin), additional substances (flavouring agent), or dose form (film-coated tablet has a distinctive odour) may all have an odour which could be characteristics of a drug. For chewable tablets, the presence or absence of a designated taste can be determined.

 

 

2. Hardness test:

A tablet needs to be strong enough to endure mechanical shaking during manufacturing, packing, and shipping, as well as resistant to friability. In general, hardness indicates how strong a tablet can be crushed. The following methods were used to gauge a tablet's strength:

(a) Cracking the tablet between the second and third fingers, using the thumb as a pivot. The tablet's strength is suitable if there is a sudden snap.

(b) The force needed to shatter a tablet in a diametric compression is the definition of tablet hardness. The tablet is put between two anvils in this test, the anvils are forced, and the crushing strength that just breaks the tablet is noted.

 

Hardness-testers

(1)           Monsanto Tester

(2)           Strong-Cobb Tester

(3) Pfizer Tester

(4) Erwika Tester

(5) Schleuniger Tester

 

Hardness for compressed tablet is 5 to 8 kp (kilopound).

 

3. Thickness test:

Equipment: Vernier caliper (precision 0.01mm)

Procedure: Select 10 tablets randomly from a batch. Place each tablet on a flat surface. Using a Vernier caliper, determine each tablet's thickness in the middle. Note measurements to the closest 0.01 mm. Determine the average thickness. Acceptance Standards: Average thickness: ± 5% of the given value. Tablets individually: within ± 10% of the average thickness.

 

4. Friability test:

A Roche friabilator can be used in a laboratory to test a tablet's friability. This is made up of a plastic container that spins at 25 rpm and drops the tablets into the friabilator 6 inches away after they have been weighed. The friabilator then runs for 100 revolutions. We weigh the tablets once more. Tablets that are compressed and lose less than 0.5% to 1.0% of their total weight are deemed acceptable.

Friability (%) = (Initial weight – final weight) / (initial weight) × 100

 

5. Content Uniformity Test:

Choose 30 tablets at random. 10 of these were examined one at a time. The tablet is considered to pass the test if 9 out of 10 have at least 85% and no more than 115% of the prescribed amount, while the tenth tablet may not have less than 75% or more than 125% of the prescribed amount. The final 20 tablets will be individually tested if these requirements are not reached, and none of them will fall outside of the 85–115% range.

 

6. Weight variation test:

20 tablets were randomly chosen, and their average weight was ascertained by weighing them. Every tablet was also weighed separately. The proportion of each case's "deviation from the average weight" was calculated and expressed as percentage. The number of tablets from the "sample size" that differ from the average weight by a "greater percentage" is limited to 2.

 

Weight variation = (Individual weight – average weight / average weight ) ×100

 

Percentage deviation < 5% for no more than 2 tablets.

Average weight

%Difference

1.130mg or less

10

2.130-324mg

7.5

3.More than 324mg

5

 

7. Disintegration Test (U.S.P.):

The U.S.P. device to test disintegration uses 6 glass tubes that are 3” long; open at the top and 10 mesh screen at the bottom end. To test for disintegration time, one tablet is placed in each tube and the basket rack is positioned in a 1-L beaker of water, simulated gastric fluid or simulated intestinal fluid at 37 ± 20 C such that the tablet remain 2.5 cm below the surface of liquid on their upward movement and not closer than 2.5 cm from the bottom of the beaker in their downward movement. Move the basket containing the tablets up and down through a distance of 5-6 cm at a frequency of 28 to 32 cycles per minute. Floating of the tablets can be prevented by placing perforated plastic discs on each tablet. According to the test the tablet must disintegrate and all particles must pass through the 10 mesh screen in the time specified. If any residue remains, it must have a soft mass.2

 

Disintegration time:

Type of tablets

Disintegration time

1.Uncoated tablets

15 minutes

2.Film coated tablets

30 minutes

3.Other coated tablets

60 minutes

4.Enteric coated tablets 0.1M HCL

Should not disintegrate in 120 minutes

5.Enteric coated tablets mixed phosphate buffer PH 6.8

60 minutes

6.Dispersible and Soluble tablets

Within 3 minutes

7.Effervescent tablets

5 minutes

 

8. Dissolution test:

1.   Preparation: Weigh and record the tablet weight. Fill the dissolution vessel with 900mL of dissolution medium (e.g., water or buffer solution). Set the temperature to 37°C±0.5°C.

2.   Test (30 minutes to 1hour): Place the tablet in the dissolution vessel. Set the agitation speed to 50-100rpm (e.g., 50rpm for immediate-release tablets). Start the timer.

3.   Sampling (at specified times, e.g., 5, 10, 15, 30 minutes): Withdraw a 10mL sample from the vessel. Filter the sample through a 0.45μm filter. Analyze the sample for active ingredient content using a suitable method (e.g., HPLC, UV spectrophotometry).

4.   Calculation (after sampling): Calculate the percentage of active ingredient dissolved at each time point. Plot the dissolution profile (percentage dissolved vs. time).

 

Dissolution Test Conditions:

Agitation speed: 50-100rpm

Temperature: 37°C±0.5°C

Dissolution medium: 900mL of water or buffer solution

Sampling times: 5, 10, 15, 30 minutes (or as specified)

Analysis method: HPLC, UV spectrophotometry, or other suitable method.

 

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Received on 04.12.2024      Revised on 30.12.2024

Accepted on 21.01.2025      Published on 10.03.2025

Available online from March 21, 2025

Research J. Science and Tech. 2025; 17(1):21-30.

DOI: 10.52711/2349-2988.2025.00003

 

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