The global nutraceutical industry is one among the fastest–growing
industries today. In 2019, the worldwide nutraceutical
ingredients market price was estimated at USD 152.0
billion and was projected to succeed in USD 228 billion by 2025,
at a CAGR of seven . a
number of the key factors driving this growth are rising
awareness about better dietary sources, growing aging population, and
increasing prevalence of chronic diseases.
The terms ‘’nutraceuticals’’ and ‘’dietary
supplements’’ are often used interchangeably. Although there's no regulatory definition
of nutraceuticals, the term generally implies purified components derived from
botanical sources and alleged to have medicinal properties
to treat and cure acute and chronic disorders. Dietary supplements, on the
opposite hand, are clearly defined by regulatory bodies. consistent
with the Dietary Supplement Health and Education Act (DSHEA), a
dietary supplement
- is a product (other than tobacco) that's intended to supplement the
diet that bears or contains one or more of the subsequent dietary ingredients: a
vitamin, a mineral, a herb or other botanical, an amino
acid, a dietary substance to be used by man to supplement the
diet by increasing the entire daily intake, or a
concentrate, metabolite, constituent, extract, or combinations of
those ingredients;
- is intended for ingestion in pill, capsule, tablet, or liquid
form;
- is not represented to be used as a
standard food or because the sole item of a meal or
diet;
- is labeled as a dietary supplement;
- includes products like an approved new drug,
certified antibiotic, or licensed biologic that was marketed as a dietary
supplement or food before approval, certification, or license (unless the
Secretary of Health and Human Services waives this provision).
Nutraceuticals are different from dietary
supplements in that:
- nutraceuticals are alleged to aid within
the prevention and/or treatment of disease/disorder additionally to supplementing the diet
- nutraceuticals must be represented either within
the sort of a
standard food or a sole sort of meal or diet
Typical nutraceuticals include:
- Plant materials
- Extracts from plants
- Foods containing additional active ingredient aside
from vitamin or minerals and providing other health benefits which
are proven scientifically
- Extracts from marine sources
- Products derived from animals and microorganisms
Why is manufacturing
nutraceuticals challenging?
Sourcing and
standardisation
The biggest drawback of plant-sourced products is
that the lack of reproducible activity. This variation within
the biochemical profile can occur thanks
to several reasons, for instance , plants harvested at
different times and locations, differences in plant variety, variations within
the extraction methods also as in assays employed for
activity determination ꟷall these factors affect reproducibility. Also, the
biological activity of plants may be a results
of additive or synergistic interaction with the
opposite components. Still, taking specific measures like standardisation of
qualitative and quantitative methods for bioactive content determination and
optimisation and control of plant growing conditions can make the manufacturing
cost-effective without compromising quality.
Physicochemical
properties
Usually, herbal products are a mix of several constituents
that are liable for the activity. Also, the
processing of those products involves variety of variables like.
- Source and quality of staple
- Harvesting method
- Storage and transportation
- Mode of extraction
- Polarity of the extracting solvents
- Stability of constituents
- Particle shape and size
All these variables can make manufacturing
operations difficult. as an example , powders of barks and
roots are usually needle-shaped fibers that inhibit flow during processing.
Such powders require milling to get fine size particles before
blending. Besides particle shape and size, there are other factors like moisture absorption,
oiliness, waxy consistency, and electricity that also cause flow
inhibition. to bypass this problem,
glidants like silica , calcium silicate, and
talc are often added to the powders.
Being of extremely small size, glidants coat the surface of larger particles
and reduce friction, absorb excess moisture, and thus, improve flow. Such
smooth–flowing powders further facilitate processing on high-speed tableting or
encapsulation machines.
The form of botanical raw materials, starting
from crude powdered leaf or root to finely powdered extract, also
creates challenges during formulation development. Hygroscopic herbal
powders cause poor flow and stability issues.
Minerals within the formulation not only
impart poor taste but also react with nutrients and vitamins within
the presence of warmth and moisture, causing
bioavailability, solubility, and tolerability issues. Different
techniques like microencapsulation,
taste-masking, stabilisation with carriers (hydrophilic proteins,
polysaccharides), chelation with a complexing agent, micro pulverisation, and
liposome applications are often wont
to overcome the challenges related to mineral fortification. The
recommended dose of trace minerals is typically in micrograms which also
poses a challenge in preparing a uniform blend for typical batch
size.
Certain phytochemicals like phytosterols clog the mill
during milling operation due to their waxy nature and
thus exhibit poor flow property. they're also difficult to
compress due to their low bulk density.
Hence, such phytochemicals are usually formulated as capsules.
Microbiological challenges
Most of the raw materials utilized
in the nutraceutical formulations are either derived from plants
or animals. Therefore, it becomes imperative to put strict controls on the
bioburden (natural microbial count) of raw materials and follow rigorous
microbiological process controls throughout the manufacturing process. Such
measures not only keep cross-contamination to a minimum but also ensure
acceptable microbial quality within the final product. Further,
the staple suppliers must be evaluated from a
microbiological perspective.
Analytical challenges for
dietary supplement
- The inherent variability of the plant components and their
specific nature poses another set of problems when it involves their analysis, as are
often seen within the following examples.
- Change in cyanocobalamin manufacturer led to method
interference with other vitamins.
- Interaction of minerals with vitamins like ascorbic
acid, vitamin D, and vitamin A results
in oxidation/reduction reactions.
- Use of coated vitamins and minerals to minimise interaction
resulted in poor analyte recovery.
- Trace amounts of vitamins or minerals within
the presence of huge quantities of other
analytes/matrix led to poor recovery/detectability.
Different types of herbal
formulations
An array of techniques is
employed to extract the active component from the plant materials. A
typical method is to grind or steep the plant parts (macerate) containing the
medicinal component and soak them during a liquid (menstruum) for
extraction. Following are the various methods employed for
herbal products.
Types
|
Definitions
|
Infusions
|
Infusions are solutions of botanical
principles obtained by soaking the powdered botanical in hot or cold
water or ethanol or hydroalcoholic mixture for a specified time and
straining. Typically, infusions are 5% in strength.
|
Decoctions
|
Decoctions are solutions of botanicals
prepared by boiling in water for at least 15 minutes and straining.
Typically, decoctions are 5% in strength.
|
Tinctures
|
Tinctures are solutions of botanical
substances in alcohol and water obtained by extracting the powdered,
flaked, or sectioned botanical.
|
Pulverata
|
These are powdered extracts of the active
component prepared by evaporating the extraction solvent.
|
Fluid extracts
|
A fluid extract is an alcoholic liquid
extract made by percolation of a botanical so that 1 ml of the
fluid extract represents 1 g of the botanical.
|
Granulation techniques
Spray drying
For most of the plant extracts, spray-drying is
employed as a preliminary step before proceeding to granulation. Since
spray-dried plant extracts usually exhibit alittle particle size and poor
flow, they often cause weight variation and poor
content uniformity within tablets. employing a proper granulation
technique, the particle size are often increased to
enhance the flow .
Direct compression
The selection of the direct compression
technique depends upon the number of ingredients within
the formulation. it's not a feasible method for
dietary supplements which contain quite one plant or mineral
ingredient. Direct compression is suggested for moisture-sensitive
herbal actives.
The use of other granulation techniques,
including fluid bed granulation, wet granulation, and roller compaction,
depends upon the character of the plant
materials and therefore the production feasibility.
Storage and stability
Phytochemicals are generally labile substances
and hence, must be stored at low temperatures throughout the manufacturing process.
Dry powders stored for an extended time may have altered
active content concentration, and it must be accounted for when
producing the ultimate dosage form. Different
extraction methods and processing steps can impact the physical and chemical
properties of the ultimate plant extract.
Manufacturers must have a radical physicochemical
characterisation of the plant extracts obtained from multiple suppliers.
Conclusion
Manufacturing plant-based nutraceuticals have
always remained a difficult task for manufacturers. the
various nature of the plant materials, variability within
the active component quantity, and therefore the associated microbial load
make the general manufacturing operations
quite complex, demanding careful planning of the whole production process.
However, the extensive knowledge of the physicochemical properties of the
active ingredients can significantly relieve the manufacturers, guiding them in
selecting the proper granulation technique for the
merchandise and setting appropriate quality
control .
References
https://pharma-trends.com/2021/04/30/manufacturing-plant-based-products-and-nutraceuticals/
Pharmaceutical Solutions
Website:
https://www.acg-world.com/
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