GB2501252A - Chia seed mucilage containing gelatin-free soft capsule shell - Google Patents

Abstract

Natural mucilage extracted from chia seed (Salvia hispanica L.) exhibits specialized water gelatinous behaviour when formulated and manufactured along with other polysaccharides and agents to form a hydrogel capsule shell wall. This will enable the mucilage hydrogel containing capsule shell on exposure to water to expand to twice its size with consequent swelling of the polymeric network and slow release of a drug within the capsule shell for example omega-3 fatty acids obtained from chia oil. The polymeric network can degrade biologically. A process for the preparation of the extracted mucilage and a capsule comprising said mucilage are disclosed. A 100% vegetarian product is prepared where both the material to be delivered and hydrogel capsule shell are produced purely from vegetarian products, free from animal derived substances.

Description

DESCRIPTION

EXTRACTED CHIA MUCILAGE VEGETARIAN GELATIN FREE SOFT OBLONG HYDROGEL CAPSULE SHELL

PREPARATION

This patent invention involves two processing techniques that creates and formats a 100% vegetarian product where both raw materials and hydrogel capsule shell is produced purely from vegetarian derivatives free from animal containing substances.

Information includes natural mucilage extracted from chia seed (Salvia hispanica L.) that exhibits specialised water gelatinous behaviour to replace or mimic the natural animal collagen synthesised gelatin.

Hydrated mucilage is formulated and manufactured along other polysaccharides and agents for hydrogel capsule shell treatment that is then cooled into ribbon sheets simultaneously rolled and filled with 100% vegetarian chia oil to compose a lipophilic soft gelatin free capsule.

SUMMARY OF INVENTION

Hydrated mucilage from chia seeds offers a novelty and inventive step because this type of mucilage extracted has valuable characteristics which is highly functional in absorbing large quantities of water, but at the same time form neutral thick gel substance that can be stable upon manufacturing as well as form a specialised structured capsule film that does not alter or interact with other components present.

This invention is distinctive as majority of polysaccharide-hydrocolloids function as swelling agent to that of a hydrogel able to shrink or swell according to bodily environmental factors for example pH, temperature or ionic electrolyte balance.

This will enable mucilage hydrogel capsule shell to expand twice its size consequently swelling of the polymeric network and therefore slow release of omega-3 molecules from chia oil that can then be metabolised along the biosynthetic pathway and allow the polymeric network to degrade biologically within the system.

The invention described would be highly desirable since all constituents are recognised to be vegetarian, natural plant source and importantly hydrocolloid properties meaning non-toxic, inexpensive but offering a multi-functional benefit (gelling, viscosity, binding and film formation).

BACKGROUND INFORMATION

Salvia hispanica widely cultivated for the tonic (chia) obtained from the seeds which exude a jelly used to flavour fruit juices other species serving a similar function include Salvia columbariae. A fragrant tea called fascomiglia is made by infusing the leaves of Salvia pomifera and salvia fruticosa.

Today Salvia hispanica is grown in Mexico, Bolivia, Argentina, Ecuador and Guatemala. In 2008, Australia was the world's largest producer of chia. Chia was unknown in Europe until 2009 when the European Union approved Salvia hispanica seeds as a novel food.

Bulking up a meal with chia gel helps lessen the amount of food consumed since chia gel is primarily made up of water.

CHEMICAL FEATURES

Chia is the richest plant based source of Omega 3, dietary fibre, protein and anti-oxidants. Other chemical elements involved are group of "natural anti-oxidants such as phenolic glycoside-Q and K, chlorogenic acid, caffeic acid, quercetin and kaempferol" (Reyes-Caudillo et al., 2007).

Linolenic acid is an 18-carbon polyunsaturated fatty acid with three cis-structure double bonds. The omega- 3 linolenic acid is called alpha-linolenic acid which has three double bonds at 9, 12, 15 positions, whereas gamma-linolenic acid, omega-6 linolenic acid, 6,9,12 positions.

Linolenic acid is principal unsaturated fatty acids in plants and an essential fatty acid in mammals that cannot be synthesized by tissues and must be obtained in the diet. It is used in the formation of prostaglandins, the result of enzymatic oxygenation of polyunsaturated fatty acids. The term linolenate refers to any salt, ester, or anionic form of linolenic acid.

Chia seed mucilage is composed of polymers most of them containing uronic acid units (mono carboxylic acids formerly derived by oxidation to a carboxylic of the terminal-CH2OH group of aldoses). They have the capacity to retain large amounts of water forming a very viscous and gelatinous gel. Chia seed mucilage is an acid i.e. its structure contains acid chemical compounds derived from monosaccharide's where there are different botanic families with this type of mucilage.

The fibre content of the chia seed corresponds to a polysaccharide with a high molecular weight (0.8-2 x106 Daltons) (Lin et al., 1994). In 1996, FAQ described it as a potential source of polysaccharide gum because of its' exceptional mucilaginous properties at low concentration in aqueous solutions (Hulse, 1996).

A tentative structure of the basic unit of the polysaccharide was proposed by Lin et al (1994) as a tetra saccharide with 4-O-metil-ci-D-glucoronopyranosyl residues occurring as branches of 3-D-xylopyranosyl on the main chain. The monosaccharide's 3-D-xylose, a-D-glucose and 4-Q-metil-ct-D-glucoronic acids were obtained by acid hydrolysis in the proportion 2:1:1 respectively.

In general mucilage's have a chemical structure formed by heterogeneous polysaccharides and simple monosaccharide's corresponding to pentose's and hexoses; xylose is found in pentose's, while galactose, rhamnose, mannose and glucose are found in hexoses.

Chia seed mucilage is composed of 48.18% expressed in glucose percentage (Antrona Method). Also present in mucilage are xylose, glucose, mannose and rhamnose, with the first two predominant in the sample in a molar 2:1 ratio.

BIQLQGICAL FEATURES

Chia seeds are definitive hydrophilic colloid (watery gelatinous glue like substance) where the seeds are hydrophilic causing saturated cells to hold the water so when mixed with foods displaces calories and fat without diluting the flavour.

Chia oil with highest form of unsaturated Qmega-3 allows increased membrane fluidity whereas, consuming saturated fats/hydrogenated fats make cell membranes that are hard and reduce movement of cell activity from one layer to another.

PHYSICAL FEATURES

The chia seeds display a unique appearance available in both black and white colours absorbing a huge quantity of water in short period of time. The shape of the chia seeds are constant but surrounded in globule of water, displaying the mechanical strength of individual seeds.

The seeds are resistant to heat, light as well as temperature cycles. Storing the chia seeds is unaffected regardless where the material is kept in any type of conditions therefore no requirements or storage conditions is needed being environmentally friendly and manufacturing costs low.

Chia seed mucilage does not have a defined melting point that is it degrades in time until calcination (>320°C), contrary to other hydrocolloids with a defined melting point, such as carrageenan with melting point somewhere between 50-70°C (Agar Gel). Mucilage originates in the plant either as a part of the contents of the cell or as a part of the wall thereof.

Chia seed mucilage reaches its' maximum absorption level in 2 hours absorbing 10 times its' weight in water. The absorption becomes constant in 7 hours reaching 0.96g of water mass. On average chia seed mucilage absorbs 0.62g of water mass, hydrating up to approximately 9.6 times its water weight in water.

The physical-chemical characteristics of chia seed mucilage support its claim to be considered a thickener for the food industry due primarily to its excellent hydration capacity replacing guar gum or carrageenan even in products with more acidic pH such as yoghurt.

In general, hydrocolloids are widely used in different applications in the food industry due to their ability to retain water. They are also notable for their thickening and gelling properties, syneresis control, emulsion stabilisation etc. (Philips and Williams 2000).

Finally, because Chis seed mucilage has no defined melting point and only degrades at temperatures above >320°C tolerating high baking temperatures while preserving the nutritional characteristics of the seed. And secondly because of its viscosity characteristics the gel formed by the Chia seed mucilage when absorbing water can be up to 25% in bread or cake formulations as egg or fat substitute while maintaining the organoleptic characteristics thus contributing to reduce the fat content of the final product.

Due to the high concentration of hydroxyl groups in the polysaccharide, mucilage's generally have a high water-binding capacity and this has led to studies of their role in plant water relations.

However, the invention that comprises chia mucilage is directing alongside the nutraceutical/pharmaceutical plus cosmetics area because this chia mucilage can correlate as new defined natural excipient or ingredient that can be acknowledged and categorised with other well-known functional substances.

NUTRITIONAL INFORMATION

The main nutritional benefits of chia seed are: 1. Omega-3 * Omega-3 is derived from polyunsaturated fats classed as "healthy good fats" which has a positive influence towards an overall improved health.

* Omega 3 & 6 are good polyunsaturated fats which has reverse effect to saturated fats by lowering blood pressure, reduce cholesterol levels preventing the risk of cardiovascular diseases to take place * Improve concentration by intake of higher the Omega-3 content, to provide more flexible and fluidity towards the membrane which can prevent depression, regulate mood yet also boost learning and concentration * Intake of Omega-3 fatty acids is central to the baby's development and growth, particularly from the third month of gestation throughout the first year, when their requirement is higher for the development of the nervous and visual systems * Omega-3 helps improve bone strength especially those who suffer from arthritis. Studies have also shown that the consumption of Omega-3 fatty acid helps control the inflammation of joints * Right amounts of Omega-3 can protect the skin from the UV rays of the sun. Further effects of Omega-3 fatty acids on the skin, particularly in alleviating skin lesions in eczema or psoriasis patients.

2. High Quality Proteins * Chia is a protein source of high-biological value, providing all essential amino acids: isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine * Proteins are a part of our bodily structure and provide the necessary material for growth and repair of human tissues and organs; for example, keratin is present in the skin, nails and hair; collagen is present in bones, tendons and cartilages, and elastin is mostly found in ligaments 3. Good source of Fibre * Seeds have great source of dietary fibre where offers suitable amounts of both soluble and insoluble fibre to provide a nutritious life style * Fibre is a nutritious substance that commonly sourced from fibre rich vegetable, fruits and seeds.

Parts of the fibre are unable to be digested due to these substances moves and circulate through the digestive tract at the same time removing waste. Fibre is a quality nutrient because it does not add any additional calories therefore best solution to a healthy weight management.

* Soluble fibre is fully digested in the intestinal gut consequently reducing and lowering high cholesterol levels * Increased amount of insoluble fibre particularly slows down the carbohydrate-sugar rate conversion that avoids high blood sugar levels taking place but also can reduce the chances of type- 2 diabetes to occur.

* Main source of fibre amazingly does derive from the actual mucilage because the mucilage itself is fibrous polysaccharide constituent therefore mucilage plays a vital nutritional role 4. Anti -oxidants * Antioxidants are a group of vegetable elements that block the damaging effects of the so-called free radicals. Most antioxidants are found in plant foods, a fact that explains the benefits of including fruit, grains, vegetables and cereals in our daily diet.

* Antioxidants are a group of vitamins, minerals, natural colorants and other vegetal and enzyme compounds (bodily substances that participate in numerous metabolic processes), that can block the adverse effect of the so-called free radicals.

* Caffeic acid is a dietary source of chlorogenic acid which functions as an anti-oxidant reduces blood sugar levels * Chlorogenic acid is part of caffeic acid and removes all oxidative species * Quercetin is known as a flavonoid that contributes protection against CNS as well as the immune and weight management properties 5. Vitamins and Minerals * The seeds offer an excellent source of calcium, phosphorus, magnesium, potassium, iron, zinc and copper. Chia seeds have 13 to 354 times more calcium, 2 to 12 times more phosphorus, and 1.6 to 9 times more potassium per 100 gram than wheat, rice, oatmeal and corn.

* Water soluble vitamins include Vitamins B and C that are relatively large components which has to be continually removed and replaced on a daily basis. This allows keeping the body to be clean and healthy plus full of energy.

* Fat soluble vitamins include Vitamins A, D, E and K that are easily absorbed from the intestinal tract and stored as body fat. These vitamins will only be released and utilised only when the body requires them. Small regular intake should be consumed moderately.

* Minerals also play a vital role in a nutritious diet to produce strong bodily structure, muscles and bones to help keep us maintaining regular movement throughout the day.

RESEARCH STUDIES

The Omega-3 ALA found in Chia is especially important for a healthy heart and research has shown it can be beneficial for lowering cholesterol, maintaining artery function and reducing the risk of cardiovascular disease. The heart foundation recommends a daily intake of 2g of Omega-3 ALA as opposed to Omega-3 DHA (found in fish oil) which should be consumed twice a week.

Essential fatty acids is a term used to describe fatty acids which are needed in order to manufacture body lipids, biological membranes and hormone like substances such as prostaglandins but which cannot be synthesised in the body and therefore must be obtained from the diet (Brooks, 1984, Newton, 1996).

Several studies suggest that diets or supplements rich in Omega-3 fatty acids lower blood pressure slightly in people with hypertension. One population study found that eating a diet rich in alpha-linolenic acid reduced the risk of high blood pressure by about 30%.

When athletes get their essential fatty acid intake the right quantities, their performance both in strength and in endurance sports improves. They recover from fatigue quicker, because recovery requires oxygen, and essential fatty acids increase the body's ability to metabolise oxygen. They also build bone strength and boost concentration.

When many seeds were hydrated in water, a highly viscous solution was formed and this same phenomenon occurred when the extracted mucilage was hydrated. Some researchers believe this same mucilage gel-forming phenomenon may occur inside the stomach when foods containing these gummy fibres or mucilage are consumed (Scheer 2001).

The gel creates a physical barrier between carbohydrates and the digestive enzymes that break them down thereby decreasing the conversion of carbohydrates into sugars while increasing the satiety sensation (Rubio 2002).

INVENTION DESCRIPTION-TO BE SOLVED

The invention described demonstrates the need to produce or compose a new form of vegetarian shell that utilises almost every component of chia seed where the coating has underwent mucilage extraction to acquire the gel mucilage which is further processed to create a fine elastic hydrogel behaviour shell.

Moreover the active fill ingredient such as Chia oil again extracted via cold pressed expeller extraction does not interact or modify the mechanical-physical features of the uniform chia shell, as the oil is lipophilic hence the oil maintains the quality but also remains consistently within the non gelatin capsule base.

Chia seeds independently form natural gel just with water, therefore, act as pharmaceutical excipient (thickening/emulsifying agent).

These substances function to provide viscous environment which help to obtain controlled release of a dosage form and sedimentation rates of both pharmaceutical and cosmetic products.

Therefore chia gel will be categorised along other agents like xanthan gum, Arabic gum etc. The capsule solves many criteria's faced by scientists, formulators as well as manufacturers due to numerous occasions where animal gelatin degrades or cooperates with other functional excipient like glycerol. This overall invention displays both hydrogel capsule shell plus filler are 100% vegetarian indicating a wider benefit towards general public who are constantly looking for pure product that is free from any animal source.

FIGURE DESCRIPTION

Figure 1 displays a concise flow chart diagram for the chia mucilage preparation where obtaining dried mucilage via whole chia seeds. The information on the right hand side explains the operation or processing parameters in order for each phase to take place, for example upon water dilution the correct temperature and volume should be sufficient i.e. ranging in volumes between 50-1000 mL to initiate the release of mucilage on the outer surface of the chia seeds but at the same time control pH which also contributes as a release factor for the mucilage properties.

Figure 2 presents the actual manufacturing/production system where several mechanisms are included.

One particular stage demonstrates re-hydrated mucilage to produce thick gel that will initially mimic behaviour to that of an animal gelatin. The next set of stages will show the process of the hydrogel capsule shell film made along with hydrated mucilage plus other hydrocolloid ingredients.

PROCESS DESCRIPTION

The process is quite extensive due to various phases are present as well as other control operational procedures. Firstly the mucilage from the chia seed shell has to be extracted via a water-solvent evaporation extraction. This entails soaking or diluting for instance 100-500g of whole chia seeds diluted in 1L purified water (freshly boiled and cooled) within a 500L vessel controlled with specified pH 7-8 to provide neutral behaviour.

After a few minutes the next step is solvent immersion whereby either HCL or NaOH was utilised to encourage the extraction procedure for the mucilage. The seed: solution mixture was automatically stirred to induct hydration effect. Once the solution thickened the mix was evaporated naturally at first in a safe controlled fume hood cupboard to evaporate remaining solvent upon duration of 4-5 hours. The solution was further evaporated in a high heat vacuum oven for complete removal of any liquid in 40-50°C.

In order to recover the dried mucilage from the seeds was performed by continuously rolling and pressing seeds on a suitable mesh sieve 50-60 where the dried mucilage was collected and stored in a desiccator ready for capsule shell film formation.

Moving to next important production side is now incorporating the hydrated mucilage along with other pharmaceutical excipients to create the hydrogel capsule shell film. The dried mucilage needs to be rehydrated by weighing the obtained yield immersed with purified water to allow the mucilage to undergo a full hydration; a maximum duration of up to 2 hours.

Once the mucilage has been converted into a gel transition the gel is homogenously mixed with glycerol; the plasticiser where for very soft capsules and those stored at ambient conditions, glycerol is the plasticiser of choice. A hot melt must be sufficiently maintained which start to bind and stabilise with the chia mucilage.

Modified starch and carrageenan (both hydrocolloid/thickening agents) are blended finely to form a consistent uniform powder that is transferred with a hot melt blend and further heated until all components are mixed extremely well.

The molten blend is moved towards the extruder with a structured die that moulds and forms a continuous capsule film under high pressure but once the film has been formed at the same time a cooling effect is added to cause the film to be lifted away from the cast drum and progress on the two rolling ribbons.

Upon duration of the rolling, the active fill ingredient i.e. Chia oil is liquid filled and encapsulated within two sheet of film and shaped in an oblong shape then sealed and conveyed to the drying stage.

Drying stage entails to remove any water present in the shell to reduce any hygroscopic interaction or increased moisture uptake that can lead to sticking.

Final stage was to conduct the usual standardised experimental and specification procedures for each capsule batch test to ensure and certify the capsules comply with all requirements.