Formulation And Evaluation of Combination Tablet of Chia Seeds and Flaxseeds for Laxative Purpose

Growing awareness of natural healthcare has led to increased interest in plant-based remedies. Among various medicinal seeds, chia (Salvia hispanica) and flax (Linum usitatissimum) stand out due to their exceptional nutritional profile and digestive benefits ^[1]. These seeds are abundant in fiber, omega-3 fatty acids, antioxidants, and lignans, making them effective in managing constipation and supporting gut health^[2].Chia seeds contain about 34–40% dietary fiber, with the majority being insoluble. When hydrated, they form a gel-like structure that helps bulk up stool, promote intestinal movement, and ease bowel evacuation^[3]. Flax seeds offer both soluble and insoluble fibers^[4]. Soluble fiber absorbs water, creating a lubricating gel, while insoluble fiber adds bulk and speeds up intestinal transit. Additionally, flaxseed mucilage soothes the intestinal lining and fosters a balanced gut microbiome^[5],[6].When used together, chia and flax seeds show complementary effects, including improved lipid metabolism, anti-inflammatory responses, enhanced antioxidant capacity, better glycemic control, and efficient bowel regulation^[7],[8]. Constipation, a common gastrointestinal disorder marked by infrequent or hard stools, may arise from poor dietary habits, dehydration, stress, or lack of physical activity. If neglected, it can cause discomfort and serious complications like fissures or hemorrhoids^[9],[10].

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            <img alt="Constipation.png" height="150" src="https://www.ijpsjournal.com/uploads/createUrl/createUrl-20250516014432-8.png" width="150">
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Fig No:2 Constipation

Herbal Tablet: A herbal tablet is a solid dosage form that contains one or more plant-based ingredients as the active components. These tablets are formulated using natural herbs or plant extracts, compressed with suitable excipients, to provide therapeutic benefits in a convenient and controlled manner^[11].

Advantages of Tablets: Accuracy of Dosage, Natural and Safe, Convenient Dosage Form, Long Shelf Life, Controlled Dose, Eco-Friendly, Better Compliance, Synergistic Effects etc^[12].

Plant  Profile 

Chia Plant: 

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            <img alt="Chia Plant.png" height="150" src="https://www.ijpsjournal.com/uploads/createUrl/createUrl-20250516014432-7.png" width="150">
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 Fig No:3 Chia Plant

Biological Description of Chia (Salvia chia) :Chia seeds are the small, oval-shaped seeds of the plant Salvia hispanica L., which belongs to the family Lamiaceae. This plant is mainly grown in warm climates such as those in Central and South America. It typically grows up to 1 to 1.2 meters tall and bears small purple or white flowers. The seeds are usually black, white, or grey and are harvested after the flowering stage. When soaked in water, chia seeds absorb many times their weight in water and form a gel-like coating due to the presence of mucilage, which helps ease constipation and supports smooth digestion. Under the microscope, chia seeds show a thick, mucilaginous outer coat after soaking. The seed coat (testa) appears as a thin, outer layer with cells that swell and form a transparent jelly layer. The endosperm is rich in oil droplets, and the embryo is curved. Nutritionally, chia seeds are packed with omega-3 fatty acids (mainly alpha-linolenic acid), protein, dietary fiber, calcium, magnesium and antioxidants. They also contain lignans and phytoestrogens, which help in maintaining hormonal balance. Because of these properties, chia seeds are used in traditional medicine and modern health supplements to promote heart health, digestion and overall well-being^[13]. Chemical Constituents: Chia seeds possess a rich and balanced chemical composition that makes them a highly nutritious superfood. They are an excellent plant-based source of omega-3 fatty acids, primarily alpha linolenic acid (ALA), which supports heart health and reduces inflammation. Chia seeds are also abundant in dietary fiber, containing both soluble and insoluble fibers that aid digestion, regulate blood sugar levels, and promote satiety. Their protein content includes all nine essential amino acids, making them a complete protein source, ideal for vegetarians and vegans. Additionally, chia seeds are packed with antioxidants, such as Chlorogenic acid, Caffeic acid and flavonoids, which help protect the body against oxidative stress. They also provide significant amounts of vitamin E, known for its role in skin protection and immune function. In terms of minerals, chia seeds are rich in calcium, magnesium, phosphorus and zinc all of which contribute to bone strength, energy production and immune system health. This comprehensive nutritional profile makes chia seeds a powerful ingredient in health-promoting diets.

Mechanism of action: Chia seeds absorb water and form a gel-like substance due to their high soluble fiber content. This increases stool bulk, softens stool and promotes bowel movements by stimulating intestinal peristalsis. They also slow down digestion, helping in steady glucose absorption^[14].

Flax seed Plant 

Biological Description of Linseed (Alsi):Linseed, commonly known as Alsi, is the seed of the Linum usitatissimum plant, which grows mainly in cool and dry climates during the winter season. It is usually sown between October and November and harvested from February to April. The plant is about 1 meter tall and has slender leaves with beautiful blue or purple flowers. After flowering, it forms small round fruits containing shiny, flat, brown seeds. These seeds are known for their unique ability to form a gel-like coating when soaked in water, due to a substance called mucilage. This makes linseed a natural remedy for constipation, as it helps smooth bowel movements. In addition to mucilage, linseeds are rich in healthy fats like omega-3 (linolenic acid), proteins, antioxidants called lignans (such as SDG) and plant-based hormones known as phytoestrogens. These nutrients contribute to many health benefits, including better digestion, heart health and hormonal balance. Because of their healing properties, linseeds are widely used in traditional medicine and modern health supplements^[15].

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Fig No:4 Flaxseed Plant

Chemical Constituents: Flaxseeds are a nutrient-dense powerhouse with a diverse chemical composition that supports overall health. They are particularly rich in omega-3 fatty acids, specifically alpha-linolenic acid (ALA), which plays a key role in reducing inflammation and promoting heart health. Flaxseeds are also an excellent source of dietary fiber, both soluble and insoluble, which aids in digestion, helps regulate blood sugar levels, and promotes a feeling of fullness. The protein content in flaxseeds is complete, containing all nine essential amino acids, making them a valuable source of plant-based protein. Additionally, flaxseeds are packed with antioxidants, including lignans, which have potent anti-inflammatory properties and may support hormonal balance. They also provide vitamin E, contributing to skin health and immune function. In terms of minerals, flaxseeds are rich in calcium, magnesium, phosphorus and potassium, which are essential for bone health, muscle function and metabolic processes. This combination of essential fatty acids, fiber, protein, antioxidants, vitamins and minerals makes flaxseeds a highly beneficial addition to any diet.

Mechanism of action: Flax seeds contain mucilage (gel-forming fiber) and omega-3 fatty acids. Mucilage retains water, increases stool volume and eases bowel passage. Flax seeds also show a mild laxative effect by lubricating the intestines and stimulating natural gut motility^[16].

Excipient Profile  

1. Microcrystalline Cellulose (MCC):

• Non-proprietary name: Microcrystalline Cellulose
• Synonyms: Avicel, MCC, Cellulose gel
• Chemical name: Cellulose
• IUPACName: Poly(1,4-β-D-glucopyranose)
• CAS number:9004-34-6
• Molecular formula:(C6H10O5)n
• Molecular Weight:162.14 g/mol
• Category: Binder, Filler,Disintegrate
• Description: White, Odorless, tasteless, free-flowing crystalline powder • Solubility: Insoluble in water and most organic solvents, but swells in water
• Melting point: Decomposes on heating above 260°C^[17].

Chemical Properties Inertness: MCC is chemically inert and does not readily react with most chemicals, acids, or bases.It is Non-toxic and biodegradable substance. They Resistant to chemical degradation under normal conditions.MCC Stable across a wide pH range (3-11), making it suitable for various formulations.

Physical Properties:

• Appearance: White to off-white, odorless, tasteless crystalline powder.
• Texture: Fine and smooth.
• Solubility: Insoluble in water and organic solvents but capable of swelling upon contact with water.
• Moisture content: Generally low, but it can absorb water vapor from the air.

Uses:

• Pharmaceutical Industry: Widely used as a binder, diluent and disintegrate in tablet and capsule formulations. Its Provides mechanical strength and promotes rapid tablet disintegration.
• Food Industry: Used as a fat substitute, thickener  and texturizer in processed foods. Classified as a dietary fiber (E460).
• Cosmetics & personal care: Acts as an absorbent and bulking agent in powders, creams and lotions.
• Other applications: Used in chromatography, as a carrier for flavors, fragrances and other actives^[18].  

2. Jaggery Powder

• Synonym: Jaggery
• Synonyms: Gur, Panela, Non-centrifugal cane sugar
• IUPAC name: Sucrose, β-D-fructofuranosyl α-D-glucopyranoside
• Molecular formula:C12H22O11  
• Molecular weight:342.30 g/mole
• Category: Natural Sweeten Binder (in traditional/herbal formulations, Taste masking agent • Nutritional excipient
• Description: Golden brown to dark brown amorphous solid; coarse powder or block; characteristic sweet taste and aroma
• Solubility: Soluble in water; insoluble in alcohol and ether
• Melting point:160–186°C^[19].

Chemical Properties:

• Reducing sugar content: Due to the presence of glucose and fructose, jaggery has reducing properties.
• Acidic nature: Mildly acidic (pH between 5.9–6.5).
• Reactivity: Can undergo Maillard reaction and caramelization when heated.
• Hygroscopic: Absorbs moisture, which can lead to microbial contamination if not stored properly.
• Oxidation: Prone to slow oxidation due to organic compounds present.

Physical Properties:

• Appearance: Golden yellow to dark brown crystalline powder, depending on purity and source.
• Taste & smell: Sweet, earthy flavor with a distinctive aroma.
• Texture: Coarse, slightly sticky due to moisture retention.
• Solubility: Soluble in hot and cold water; insoluble in organic solvents.
• Hygroscopic: Can absorb moisture from the air, especially in humid conditions.
• Melting Point: Varies between 95–120°C, depending on moisture and composition.

Uses:

• Nutraceuticals & Herbal Medicines: Used in traditional systems like Ayurveda for its detoxifying and digestive properties. Acts as a natural laxative and carrier for herbal actives.
• Food & beverage industry: Used as a natural sweetener in candies, bakery, beverages and traditional sweets.
• Pharmaceutical formulations: Used to mask bitter taste and as a binding and bulking agent in herbal tablets and granules^[20].

3.Lactose

• Non-proprietary name: Lactose
• Synonyms: Milk sugar, Lactose monohydrate, Lactose anhydrous
• Chemicalname:4-O-β-D-galactopyranosyl-D-glucose
• IUPAC name:Β-D-galactopyranosyl-(1→4)-D-glucose
• CAS number: Lactose monohydrate: 64044-51-5Anhydrous lactose: 63-42-3 • Molecular formula: Monohydrate: C12H22O11·H2O, Anhydrous: C12H22O11
• Molecular weight: Monohydrate: 360.31 g/mole, Anhydrous: 342.30 g/mole .
• Category: Diluent (Filler), Binder, Tablet and capsule excipient
• Description: White to off-white, crystalline powder; odorless; slightly sweet taste
• Solubility: Freely soluble in water, practically insoluble in ethanol^[21].
• Chemical Structure:

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            <img alt="Structure of Lactose.png" height="150" src="https://www.ijpsjournal.com/uploads/createUrl/createUrl-20250516014432-5.png" width="150">
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Fig No 6 : Structure of Lactose

Chemical Properties:

• Reducing sugar: Has a free aldehyde group on the glucose moiety, allowing it to participate in redox reactions.
• Hydrolysis: Can be hydrolyzed by lactase enzyme or acids into glucose and galactose.
• Reactivity: Undergoes Maillard reaction in presence of amino groups.
• pH sensitivity: Stable in neutral conditions, can decompose in acidic or basic media.

Physical Properties:

• Appearance: White, crystalline powder
• Taste: Mildly sweet (about 1/6^th as sweet as sucrose)

Solubility: Freely soluble in water (18g/100 mL at 25°C), insoluble in alcohol.

• Hygroscopic: Moderate, more in monohydrate form.
• Melting Point:202°C 
• Flow ability: Poor, often granulated to improve processing Uses:
• Pharmaceutical industry: Commonly used as diluent and filler in tablets, capsules  and powders. Compatible with a wide range of active pharmaceutical ingredients (APIs).
• Food industry: Used in infant formulas, baked goods and dairy-based products.
• Biotechnology: As a fermentation substrate in growth media for certain microbes.
• Diagnostic field: Used in lactose tolerance testing^[22].

4. Talc

• Non-proprietary name: Talc
• Synonyms: Purified talc, French chalk, Magnesium silicate
• Chemical name: Hydrated magnesium silicate
• IUPAC name: Magnesium silicate hydroxide
• CAS number:14807-96-6
• Molecular formula:Mg3Si4O10(OH)2
• Molecular weight:379.27 g/mole
• Category: Glidant, Anti-adherent, Diluent (in topical powders)
• Description: Fine, white to grayish-white powder; greasy to touch; odorless and tasteless.

Chemical Structure: 

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            <img alt="Structure of Talc Chemical Properties.png" height="150" src="https://www.ijpsjournal.com/uploads/createUrl/createUrl-20250516014432-4.png" width="150">
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Fig No 7 : Structure of Talc Chemical Properties:

• Inertness: Chemically inert under normal conditions.
• Acid/Base resistance: Not reactive to dilute acids or bases.Non-combustible and hydrophobic in nature.

Does not dissolve or react with water or most solvents^[23].

Physical Properties:

• Appearance: White to greyish-green powder
• Texture: Extremely soft and soapy
• Solubility: Insoluble in water
• Thermal stability: Retains structure at high temperatures
• Density: ~2.7–2.8 g/cm³
• Melting Point: Approximately 1500°C
• Boiling Point: Not applicable (mineral does not boil; remains solid until decomposition)

Uses:

• Pharmaceuticals: Acts as Glidant to improve powder flow. Used in dusting powders, tablet coatings, and   topical formulations.
• Cosmetics: Major ingredient in baby powders and facial powders due to smoothness and absorbency.
• Industrial: Used in ceramics, paints, plastics and paper as a filler and lubricant.
• Medical: Occasionally used as a pleurisies agent^[24].

 5.Magnesium Stearate Chemical Structure:

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            <img alt="Structure of Magnesium Stearate.png" height="150" src="https://www.ijpsjournal.com/uploads/createUrl/createUrl-20250516014432-3.png" width="150">
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Fig.No 8 : Structure of Magnesium Stearate

Chemical Properties: Inert and non-toxic under normal conditions. Insoluble in water, ethanol, and ether. Can undergo thermal decomposition at high temperatures. Forms a thin, hydrophobic film around particles, affecting dissolution

Physical Properties:

• Appearance: Fine white powder
• Odor: Slight fatty odor or odorless
• Taste: Tasteless
• Texture: Greasy and light
• Solubility: Practically insoluble in all solvents
• Density: ~1.03 g/cm
• Melting Point: Decomposes between 88-150°C^[25].

Uses:

• Pharmaceuticals: Widely used as a lubricant in tablet and capsule manufacturing to prevent sticking. Also acts as an anti-adherent and flow agent.

• Cosmetics: Used in pressed powders and personal care items for texture enhancement.
• Industrial: Used in plastics, rubber and mold-releasing agents^[26].

Material:

Equipment:

Tablet No: 2  Equipment List^[28].

METHOD AND EVALUATION

1. Pre-formulation Study:

• Pre-formulation Study of Chia Seed Powder:

Tablet No: 3 Preformulation Study of chia seeds Powder^[29].

• Pre-formulation Study of Flaxseed Plant:

Tablet No:4 Pre-formulation Study of Flaxseed Powder^[30].

• Pre-formulation Study of Mixed Chia and Flax Seeds powder:

Tablet No: 5 Pre-formulation Study of Mixed Chia and Flax Seeds Powder^[31].

Method/ Procedure:

Stepwise Procedure:

• 1. Weighing: Accurately weigh chia seed powder, flaxseed powder, MCC, jaggery powder (if applicable), lactose, talc and magnesium stearate as per F1, F2, or F3 formulation.
  2. Primary Mixing: Blend chia seed powder, flaxseed powder, MCC, jaggery powder (if used), and lactose uniformly.
  3. Add Talc: Incorporate talc into the mixture and mix briefly.
  4. Add Magnesium Stearate: Add magnesium stearate and gently mix to avoid over-blending.
  5. Tablet Compression: Transfer the final blend to the tablet press and compress into tablets.
  6. Evaluation: Perform evaluation tests like weight variation, hardness, friability, disintegration, and thickness.
• Formulation table:

Tablet No: 6 Formulation Table

Formulation development: The development of a chia and flaxseed-based laxative tablet begins with a thorough review of the seeds’ medicinal benefits, focusing on their fiber and mucilage content. Raw materials are authenticated and undergo characterization to assess their water retention and swelling properties. Compatibility studies ensure stability with excipients, while powder flow properties are optimized for tablet production. The formulation is developed using the direct compression method, blending chia and flaxseed powders with excipients like MCC, lactose, talc and magnesium stearate. The tablets are compressed and evaluated for hardness, friability, weight variation, disintegration and dissolution. Stability studies are conducted to assess shelf life and long-term effectiveness, aiming to create a safe, natural laxative alternative^[32].

Post Formulation Study:

1. Hardness Test:

The Pfizer Hardness Test evaluates the mechanical strength of tablets to ensure they can withstand handling, packaging and transportation without breaking or chipping. It is based on the principle that tablet hardness is the force required to break a tablet in a diametric compression test, measured in kilograms (kg), Newton (N), or kilopond (kp). The commonly used instruments are the Monsanto Hardness Tester, which uses a spring mechanism and the Pfizer Hardness Tester, which operates like a plier with a calibrated scale. The procedure involves randomly selecting 6 tablets, placing each between the anvils of the tester, gradually applying force until the tablet breaks and recording the force required for each. The average hardness is then calculated. The acceptable range for conventional tablets is 4–8 kg/cm², while herbal tablets may be slightly softer. Tablets that are too hard may fail to disintegrate and those too soft may break during handling^[33].

2. Friability Test:

The Friability Test measures a tablet’s resistance to surface abrasion during manufacturing and transportation. It uses a Roche Friabilators, where 20 tablets are initially weighed (W?), placed in a rotating drum (25 rpm for 4 minutes, totaling 100 revolutions), dedustedand in weighed again (W?). The percentage weight loss is calculated using the formula: Friability (%) = [(W? - W?) / W?] × 100.The acceptance criteria specify that the weight loss should be less than 1.0%. Tablets that break, cap, or laminate during the test automatically fail^[34].

3.Weight Variation Test: The Weight Variation Test ensures uniformity of tablet weight, indicating consistent distribution of active ingredients. 20 tablets are randomly selected and individually weighed. The average weight is calculated, and the percentage deviation for each tablet is determined using: % Deviation = [(Individual Weight – Average Weight) / Average Weight] × 100. According to IP/BP standards, for tablets weighing 80–250 mg, the allowed deviation is ±7.5%; for those above 250 mg, it is ±5%. The batch fails if more than 2 tablets deviate from these limits or any one tablet deviates by more than double the permissible limit ^[35].

4.Disintegration Test: The Disintegration Test assesses the time required for a tablet to break down under physiological conditions. It uses a Disintegration Test Apparatus with a medium such as distilled water, 0.1 N HCl, or pH 6.8 phosphate buffer, maintained at 37 ± 2°C. Tablets are placed in a basket-rack assembly moving up and down at a frequency of 28–32 cycles/min. One tablet is placed in each of the six tubes and the time for complete disintegration (leaving no residue except insoluble shell) is recorded. The acceptance criteria are: Uncoated tablets should disintegrate within 15 minutes, film-coated tablets within 30 minutes and enteric coated tablets should show no disintegration in 0.1 N HCl for 2 hours, but should disintegrate within 30 minutes in pH 6.8 buffer.

5. Swelling Index:

The swelling index is an important evaluation parameter for hydrophilic formulations such as chia seed based laxative tablets. It measures the ability of the tablet to absorb water and swell, which is directly related to its mucilage-forming capacity and bulk-forming laxative effect. The test was conducted by weighing the tablet initially (W?), then immersing it in distilled water at 37±0.5°C for 4 hours. After the specified time, the tablet was removed, surface moisture was gently blotted and the swollen weight (W?) was recorded. The swelling index was then calculated using the formula: Swelling Index (%) = [(W? - W?) / W?] × 100.

The results revealed that batch F1 had a swelling index of 110%, batch F2 exhibited 90%, while batch F3 showed the highest value of 150%. The higher swelling index of batch F3 suggests better hydration and mucilage formation, which is desirable for a bulk-forming laxative. Hence, F3 was considered the most optimal formulation based on this parameter^[36].

8. RESULT AND DISCUSSION 

Result: The formulated tablets were evaluated for various physicochemical parameters. The observations are recorded below:

Preformulation Study of Powder Blend:

Table No: 7 Preformulation Study of Powder Blend of Formulation Batches

Discussion: Good flow properties (Carr’s Index 14.36%, angle of repose 20.8°) and acceptable pH (5.7), but not the most optimal.

Similar to Batch 1 with slightly better angle of repose (19.5°) but slightly poorer compressibility (Carr’s Index 15.36%).

Higher density and slightly poorer flow (angle 29.8°), but acceptable and better pH (6.9), supporting formulation stability.

Formulation Development Results

Evaluation of  Batch: