Formulation and evaluation of herbal gummies from Bacopa monnieri and walnut oil for memory enhancing

Introduction

Learning and daily performance are very essential components of our existence, especially in the current fast-paced world. In recent years, the global interest in cognitive health has significantly increased due to the rising prevalence of neurodegenerative disorders, ageassociated memory decline, and attention-deficit conditions in both paediatric and elderly populations (Prince et al., 2015) [14] . As more academic and lifestyle pressures affect people, mostly students and working professionals, there is an increasing need for natural mental enhancers that are safe yet effective. The demand is also underscored by studies that show cognitive impairment can severely impair performance and quality of life (Stough et al., 2001) [4] . The growing burden of diseases such as Alzheimer's disease, mild cognitive impairment (MCI), and attention-deficit/hyperactivity disorder (ADHD) has encouraged the search for safer, natural alternatives to synthetic nootropics (Salloway et al., 2014) [16] . One of the hopeful solutions is Bacopa monnieri, also known as Brahmi, a traditionally proven medicinal plant used in Ayurvedic medicine. It has been used historically to improve cognitive abilities, especially memory retention and learning capacity (Russo &Borrelli, 2005) [3] . Several clinical and preclinical researches have revealed the neuropharmacological efficacies of Bacopa monnieri, featuring its antioxidant, neuroprotective, and memoryimproving activities (Calabrese et al., 2008) [2] . All these therapeutic effects can mainly be credited to its bioactive ingredients, particularly bacosides A and B, which are thought to improve synaptic transmission and help repair injured neurons (Aguiar &Borowski, 2013) [1] .

Complementing Bacopa monnieri, walnut oil (extracted from Juglans regia) is rich in omega-3 fatty acids (especially alpha-linolenic acid), polyunsaturated fats, vitamin E, and antioxidants, which play an important role in brain development and neuroprotection (Ros et al., 2018). Omega-3 fatty acids are integral to neuronal membrane fluidity and neurotransmission and are known to support long-term memory and reduce inflammation associated with cognitive disorders (Gómez-Pinilla, 2008) [13] . Recent studies have indicated that dietary supplementation with walnuts or walnut oil improves working memory and cognitive flexibility, making it a valuable candidate for combination with Bacopa monnieri in cognitive health supplements (Pribis & Shukitt-Hale, 2014) [15] . Although both are well-documented in their uses as Bacopa monnieri and walnut oil, their reformulation into a patientfriendly dosage form is a challenge. Conventional dosage forms like powders, tablets, and syrups tend to have poor palatability, low patient compliance, and are associated with variable bioavailability (Morgan & Stevens, 2010) [9] . Swallowable solid dosage forms in particular for paediatric and geriatric patients are problematic in terms of administration, requiring alternative delivery formats. Here, gummy-based nutraceuticals provide a new and promising alternative. Gummies are edible, tasty, and easy to swallow, enhancing patient compliance in addition to offering a platform for stable encapsulation of herbal actives and oils (Deshmukh & Gursale, 2020). The dosage form of the gummy also supports dosing accuracy, cover-up of bad taste, and increased consumer appeal, particularly with children. The current research will design and test herbal gummies of Bacopa monnieri and walnut oil to create a synergistic, efficient, and enjoyable delivery system for enhancing memory. The formulation will be tested for physicochemical attributes, organoleptic features, drug content, in vitro dissolution, and stability, as per regulatory and scientific guidelines. This study is meant to fill the gap between conventional herbal knowledge and contemporary nutraceutical technology for better cognitive well-being.

Rationale

Cognitive

decline, memory impairment, and neurodegenerative disorders such as Alzheimer's disease are increasingly prevalent in both aging populations and young individuals exposed to stress, poor diet, and sedentary lifestyles (Singh et al., 2016) [12] . There is a growing demand for safe, effective, and natural interventions that can support brain health and enhance memory function without the side effects commonly associated with synthetic drugs. The growing interest in natural nootropic agents has drawn attention to Bacopa monnieri (commonly known as Brahmi), a well-established Ayurvedic herb known for its memory-enhancing, neuroprotective, and antioxidant properties (Aguiar & Borowski, 2013; Singh & Dhawan, 1997) [1,12] . Scientific studies have confirmed that Bacopa monnieri contains bioactive compounds such as bacosides, which enhance synaptic communication and support neuronal repair (Russo & Borrelli, 2005) [3] . Clinical trials have shown its effectiveness in improving cognitive performance, especially memory recall and retention (Pase et al., 2012) [7] . Walnut oil, rich in omega-3 fatty acids (especially alphalinolenic acid), polyphenols, and antioxidants, contributes to brain development and function (Poulose et al., 2014). [26] It reduces neuroinflammation, supports neurotransmitter function, and combats oxidative stress-all of which are vital in preventing cognitive decline and enhancing memory (Holcomb et al., 2014) [24] . Despite its proven efficacy, conventional forms of Bacopa monnieri such as powders, capsules, and syrups suffer from issues like poor palatability, patient non-compliance, and limited bioavailability (Morgan & Stevens, 2010) [9] . To overcome these challenges, gummy formulations offer a novel, convenient, and palatable dosage form, especially suitable for children and elderly individuals who may have difficulty swallowing traditional pills (Yadav et al., 2024) [11] . Gummies also provide a stable matrix for delivering herbal actives while ensuring dose uniformity, ease of administration, and improved patient adherence. Gummy formulations also allow the inclusion of oil-based actives with improved bioavailability when paired with suitable carriers (Rajput & Haldankar, 2021) [27] . Furthermore, there is a research gap in the standardized development and scientific evaluation of Bacopa monnieri gummies, particularly in terms of physicochemical characteristics, drug content, organoleptic acceptability, and in vitro drug release. Addressing this gap is essential to substantiate the therapeutic value of Bacopa-based nutraceutical gummies and to facilitate their integration into modern preventive and therapeutic healthcare systems. This study aims to formulate and evaluate a herbal gummy supplement combining Bacopa monnieri extract and walnut oil for memory enhancement. The innovation lies in the dual-herb approach and its delivery via a patient-compliant dosage form, which may improve adherence and therapeutic outcomes. The formulation will be assessed for its physicochemical properties, acceptability, and cognitive benefits, potentially offering a natural, safe, and effective alternative to synthetic nootropics.

Aim

To formulate and evaluate herbal gummies incorporating Bacopa monnieri extract and walnut oil for potential memory-enhancing effects.

Objectives  To extract and standardize the bioactive constituents of

Bacopa monnieri (primarily bacosides) for use in gummy formulation.  To evaluate the nutritional and neuroprotective properties of walnut oil, particularly its omega-3 fatty acid and antioxidant content, relevant to memory enhancement.  To develop a stable and palatable gummy formulation using suitable gelling agents and excipients that can encapsulate both aqueous and oil-based actives effectively.  To assess the physicochemical properties of the formulated gummies, including texture, pH, moisture content, drug content uniformity, and stability.  To assess organoleptic acceptability and patient compliance potential, especially in paediatric and geriatric populations.  To compare the memory-enhancing efficacy of the combination formulation against individual extracts to determine synergistic benefits.

Plant Profile

A. Brahmi 1. Scientific Name: Bacopa monnieri (L.) Wettst.

Common Names

Taxonomy

Botanical Description

 Growth Habit: Creeping, mat-forming, succulent perennial herb.  Height: Up to 15-30 cm tall.  Leaves: Oblong, sessile, thick, and fleshy with a smooth margin; arranged oppositely.  Flowers: Small, actinomorphic, pale blue to violet (sometimes white); axillary with five petals.  Roots: Fibrous root system; spreads via stolons.  Stem: Soft, green, branched, and glabrous.  Fruits: Oval capsules containing numerous minute seeds.

Habitat and Distribution

 Geographical Distribution: Native to India, Nepal, China, Taiwan, Vietnam, and Sri Lanka; also found in Australia, the Americas, and Africa.  Habitat: Prefers marshy, wet, and humid environments; commonly found near ponds, wetlands, and rice fields.  Cultivation: Grows well in sandy loam or clay soil with good moisture retention; often propagated via stem cuttings in wet environment. [13] .  Anti-inflammatory: Walnut oil suppresses proinflammatory cytokines and reduces CRP levels.  Cardioprotective: Regular walnut consumption reduces LDL cholesterol and improves endothelial function (Ros, 2010).  Anti-cancer: Ellagic acid and juglone exhibit antiproliferative effects against certain cancer cell lines.  Antimicrobial: Walnut hulls and leaves possess antimicrobial and antifungal activities due to juglone and phenolic compounds.

Traditional Uses

 Kernels are used as a brain tonic and for sexual health.  Oil is used for skin nourishment and to treat eczema.

 Leaves and bark are used topically for wounds, inflammations, and fungal infections.  Decoctions from green husks are employed as astringents and vermifuges.

Drug Profile

A. Bacoside A: [Aguiar et al., 2013 [1] ; Kongkeaw et al., 2014] [5] 1. Overview: Bacoside A is a major active compound derived from the leaves and stems OF Bacopa monnieri.

IUPAC

Name: (5R,8R,9S,10S,13R,14R,17S)-3-[(2R,3R,4R,5S,6R)-3,4-dihydroxy-6-(hydroxymethyl)-5-[(2S,3R,4S,5S)-3,4,5-trihydroxyoxan-2-yl]oxyoxan-2-yl]oxy-10-(hydroxymethyl)-17-[(2S)-2-hydroxy-6methylhept-5-en-2-yl]-4,4,8,14-tetramethyl- [13,43] 1. Overview: Gelatin is a natural, water-soluble, biodegradable polymer obtained by the partial hydrolysis of collagen, a structural protein abundant in the connective tissues, skin, and bones of animals (commonly pigs, cattle, or fish).

Chemical Structure:

Gelatin is a mixture of peptides and proteins composed of repeating sequences of amino acids-mainly glycine (approx. 33%), proline, and hydroxyproline-forming triple-helical structures similar to those in native collagen.  General Repeat Unit: Gly-X-Y (where X and Y are often proline and hydroxyproline)

Physical Properties

. Preparation of Plant Material

Dried aerial parts of Bacopa monnieri are coarsely powdered using a mechanical grinder and sieved through mesh size 40 to ensure uniformity.

Packing

Place 100 g of powdered material in a thimble made from filter paper and insert it into the Soxhlet extractor.

Extraction

Fill the distillation flask with 400-500 mL of ethanol or methanol. Attach the Soxhlet extractor and condenser. Heat gently using a heating mantle so the solvent refluxes and siphons through the plant material repeatedly for 6-8 hours (about 10-15 cycles) until the extract becomes colourless.

Filtration

Filter the extract using Whatman filter paper to remove plant or powder debris from it before concentrating it.

Solvent Recovery: After completion, concentrate the extract using water bath to remove the solvent. [19,45] Hydration of Gelatin 1. Weigh 10 g of gelatin and soak it in 30 mL of purified water. 2. Allow it to bloom for 30 minutes at room temperature.

Preparation of Aqueous Phase

Dissolve 10 g honey, 5 g glycerin, 0.5 g citric acid, and 2 g Bacopa monnieri extract in 40 mL of warm water (45-50°C) under constant stirring. Method: 1 g of gummy was dissolved in 10 mL distilled water. pH was measured using a digital pH meter.

Incorporation of

Result: pH = 4.82±0.05  Significance: This pH is within the acceptable range (3.5-5.5) for gummies, ensuring product stability and palatability.  Viscosity: [Patil et al., 2019] [45]  Method: Viscosity of the melted gummy formulation (before molding) was measured using a Brookfield viscometer at 25°C.  Result: Viscosity = 3450±50 cP  Significance: Indicates suitable flow and moldability for uniform gummy formation.

Weight Variation: [USP, 2020]

 Method: 20 gummies were randomly selected and weighed individually using an analytical balance.  Result: Average weight = 3.02 g±0.04 g  Limit: Within ±7.5% variation (as per pharmacopeial guidelines for dosage forms below 5 g).

Moisture Content: [AOAC, 2000] [51]  Method: Determined by drying 1 g gummy in a hot air oven at 105°C for 4 hours.  Result: Moisture content = 14.2%±0.5%  Significance: Ensures product chewiness and shelf stability.

Texture Profile Analysis (TPA)

 Method: Texture analyser measured hardness, elasticity, and chewiness.  Result:  Hardness: 1.8 N  Elasticity: 72%  Chewiness: 0.9 N  Significance: Results confirm suitable sensory and mechanical properties for a paediatric-friendly gummy.

Results and discussion Results

Discussion

The formulated herbal gummies exhibited favourable organoleptic and physicochemical characteristics, supporting their suitability as a paediatric-friendly memoryenhancing supplement. The appearance was smooth and uniform, with abrown colour and pleasant herbal aroma and taste, which are critical for patient compliance, especially in children. The pH value of 4.82 falls within the ideal range for oral gummies, ensuring product stability and minimizing microbial growth. The viscosity (3450±50 cP) confirmed proper flow for effective moulding without compromising uniformity. The gummies also showed acceptable weight variation and moisture content (14.2%), indicating good consistency and stability. Texture analysis showed optimal hardness (1.8 N), elasticity (72%), and chewiness (0.9 N), suggesting they are easy to chew and palatable. Overall, these results confirm that the formulation meets standard quality attributes for herbal chewable dosage forms and holds potential as a natural cognitive enhancer.

Conclusion

The current research was able to develop and test herbal gummies containing Bacopa monnieri extract and walnut oil for delivering a tasty and effective natural memoryenhancing supplement. The optimal composition of the product was achieved with appropriate excipients like gelatin, sweeteners, and plasticizers for achieving optimal organoleptic and physicochemical attributes. The final product exhibited good physical properties, such as a smooth appearance, sweet taste, suitable hardness, chewiness, and elasticity. These characteristics are important for patient compliance, particularly with paediatric and elderly groups of patients. pH value (4.82±0.05) and moisture level (14.2%) were in acceptable limits, providing microbial stability as well as shelf life. Texture profiling ensured proper chewability without loss of structural integrity. These characteristics reflect the stability and acceptability of the formulation as a new delivery system for herbal neuroenhancers. Pharmacologically, Bacopa monnieri is well-characterized for its nootropic, antioxidant, and neuroprotective effects (Stough et al., 2001 [4] ; Aguiar & Borowski, 2013) [1] , whereas walnut oil is a source of alpha-linolenic acid and polyunsaturated fatty acids, which sustain neuronal activity and memory (Gómez-Pinilla, 2008) [13] . The combination of these agents together in gummy form represents a novel and distinct way of supporting cognition. This research provides a foundation for the creation of herbal memory-enhancing gummies as a consumer-friendly, effective, and safe supplement. In vivo studies and clinical trials are needed further to validate the formulation's therapeutic efficacy in target populations.

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