Formulation And Evaluation of Effervescent Granules Containing Clitoria Ternatea and Zingiber Officinal as An Antioxidant

Effervescent granules are an innovative dosage form designed to improve the solubility, Absorption, and palatability of bioactive compounds. These granules contain a mixture of acids  (such as citric and tartaric acid) and bases (such as sodium bicarbonate), which react in the presence of water releases carbon dioxide, creating effervescent effect. Effervescent granules offer several advantages, particularly in pharmaceutical and nutraceutical applications.

ADVANTAGES-

• Rapid onset of action
• Improved patient compliance
• Enhance taste and palatability
• Accurate dosing
• Better bioavailability
• Reduced gastrointestinal irritation
• Stable in dry form

Aim And Objective:

Aim – Formulation and evaluation of effervescent granules containing clitoria ternatea and zinigiber officinale extract.

Objective - 

• To optimize the effervescent granules formulation incorporating clitoria ternatea and Zingiber officinale extracts.
• To evaluate evaluation parameters of the formulated effervescent granules.
• To evaluate the antioxidant activity of the effervescent garnules by using assay.

DRUG PROFILE:

Clitroia ternatea -

Taxonomic hierarchy

Kingdom: Plantae

Phylum: Angiosperms

Order: Fabales

Family: Fabaceae

Genus: Clitoria

Species: C. ternatea

Phytochemical Constituents: -Clitoria ternatea contained tannins, phlobatannin, carbohydrates, saponins, triterpenoids, phenols, flavanoids, flavonol glycosides, proteins, alkaloids, antharaquinone, anthocyanins, cardiac glycosides.

Pharmacological activity:- The extract of flower shows the antimicrobial activity, hypoglycemic activity, antipyretic activity, antioxidant activity and promote hair and skin health.

Fig no.1 Clitoria ternatea flower

Zingiber officinale –

Taxonomic hierarchy

Kingdom: Plantae

Phylum: Angiosperms

Order: Zingiberales

Family: Zingiberaceae

Genus: Zingiber

Species: Z. officinale

Phytochemical constituent- Phenolic compounds such as gingerols, shagols, paradol, zingerone. Essentsil oils such as zingiberene, beta-sesquiphellandrene, curcumene.Carbohydrates and fibers Minerals and vitamins,Flavonoids, Tannins, Saponin.

Pharmacological activity- Anti-inflammatory activity, antioxidant activity, anti-nausea and gastro protective activity, antimicrobial antiviral activity, cardio protective activity, hypoglycemic activity, anticancer activity.

Fig No. Zingiber Officinale Root

MATERIAL AND METHODS:

Preparation of extract clitoria ternatea –

1. Dry and powder the Clitoria ternatea flowers.
2. Place the powder in a thimble inside the Soxhlet extractor.
3. Use a suitable solvent (e.g., ethanol).
4. Set up the Soxhlet apparatus and heat the solvent to reflux.
5. Allow extraction to continue for 4–6 hours.
6. After extraction, evaporate the solvent to obtain the crude extract.

Preparation of extract zingiber officinal –

1. Dry and powder the ginger rhizomes.
2. Weigh a known amount (e.g., 20–30 g) of the powder.
3. Add it to a round-bottom flask with a suitable solvent (e.g., ethanol or methanol).
4. Set up a reflux condenser and heat gently for 2–4 hours.
5. Cool, filter, and concentrate the extract by evaporation.

Preparation Procedure -

1. Take required quantity of citric acid and sodium bicarbonate pass through seive no.14.
2. Take above citric acid and sodium bicarbonate in mortar pestle and mix well.
3. Add clitoria ternatea and ginger extract in mortar pestle and mix well
4. Add flavouring and sweetning agent in mixture
5. Make a starch paste by adding starch in sufficient quantity of water and heat on water bath with Continuous stirring until starch paste is formed
6. Add starch paste gradually during mixing and lactose in mixture and mix until dampmass is Formed.
7. Damp mass was seived using a seive no 12.
8. Obtained granules dried in a hot air oven at 40-60 for 1 2 hours.
9. The dried granules again seived by using seive no 16.
10. Obtained granules are tested for their evaluation parameters.

Table No.1 Formula for Effervescent Granules

Evaluation Parameters:

Appearance: -

Color, texture and presence of any clumping or caking.

Particle size distribution -

To determine particle size distribution of granules most common and practical method is sieve analysis. By using obtained results the particle size distribution curve is plotted.

Flow properties -

Angle of repose – The angle of repose is a permanent3D angle (compared to a straight bottom),

Inferred from the formed cone. If the material is placed on the pile,It will slip down until the particles that usually form the surface at an angle ? wear out and balance with gravity. The angle of repose less than 40°C, shows satisfactory fluidity And greater than 40°C shows continuity. The calculation formula is as follows:

Tan ? = µ;

 ? = tan-1 µ; or

 ? = tan-1(h/r)

 Where h = height of the heap

 R = radius of base of heap

 ? = angle of repose

Bulk density – The bulk density of powder is the proportion of the mass of an untapped powder sample and its mass including the contribution of the interparticulate non-viable mass. The bulk density is shown in grams per milliliter (g/ml). Calculated by using the formula;

Bulk density (ρb) = weight of dry powder (M)/Bulk volume (Vb)

Where M = weight of powder

Vb= Bulk volume of powder.

Tapped density - The tap density is the increased bulk density acquired after mechanically tapping the container carrying the powder sample.

The tap density can be calculated by the following equation;

Tapped density (ρt) = weight of dry powder (M)/Tapped volume (Vt)

Where M = weight of powder Vt = Minimum volume occupied after tapping

Carr’s Index (CI)-  It can be calculated by applying the following equation;

CI (%) = [Tapped density (ρt) – Bulk density(ρb)/ Tapped density(ρt)]*100

Where; (ρt) = Tapped density

(ρb) = Bulk density

Hausner’s ratio – Hausner’s ratio is a guide of ease of powder flow. It is the ratio of of tapped density by bulk density. Lesser the value of Hausner’s ratio, better is the flow characteristic. It

Can be calculated by formula:

Hausner’s ratio = Tapped density/Bulk density

pH:- Measured after dissolution in water to ensure suitable for administration by using digital pH meter.

Content uniformity- Content uniformity of granules refers to how evenly the active pharmaceutical ingredient (API) is distributed throughout a batch of granules. It ensures each disage unit (e.g., tablet or capsule made from the granules) contains the correct amount of API.  acceptance Criteria (e.g., per USP <905>).

Effervescent time – Time taken for the granules to completely dissolve and release co2 in water.

Moisture content – Moisture content of granules refers to the amount of water present in the granules, typically expressed as a percentage of the total weight. It’s a critical parameter that affects the granules’ stability, flow properties, compressibility, and shelf life.

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RESULTS:

Phytochemical tests-

Table No 4. Phytochemical Test

Evaluation parameters –

Table no.3 Evaluation parameters results

Fig No.5 Particle Size Distribution Plot

Fig no.6 Content uniformity graph

Antioxidant Activity of Formulation :-

Weigh 0.5 gm of sample, then dissolve in 50ml of distilled water. Weigh 4mg of DPPH and dissolve in 100ml of methanol. 2ml of pipette from sample into a 50 ml volumetric flask then add 2 ml of DPPH solution and incubate in a dark room for 30 minutes. Add 10ml of methanol to the solution that has been incubated and homogenized. Make blank by adding 2ml of DPPH solution and 10ml of methanol. Make sample concentrations of 20,15,10,5 and 2.5% Analyze using UV-vis spectrophotometry method.

%Inhibition=(blank abs.-sample abs.)/( blank abs.)

Lower the IC50 value higher is the antioxidant activity.

Table no.4 IC50 value if the samples

Fig No.7 Antioxidant Activity Plot