Advantages such as low cost and less toxicity, which give them an edge over their synthetic counterparts, are spurring the use of herbal excipients in the pharma industry By Sachin Jagdale
Not many patients know that the drug they consume contains very less amount of actual active molecule, the rest is made up of excipients. They are defined as “a natural or synthetic substance formulated alongside the active ingredient of a medication, used for the purpose of long-term stabilisation, bulking up solid formulations that contain potent active ingredients, or to confer a therapeutic enhancement on the active ingredient in the final dosage form, such as facilitating drug absorption, reducing viscosity, or enhancing solubility.” These ingredients are present in all marketed drugs. Though inert by nature they are as important as the active molecules as it is the excipent’s role to keep a drug stable and help perform its duties. Synthetic excipients have ruled the market for a long time, but lately, herbal excipients have been giving them serious competition.
Growth drivers of herbal excipients
“Need for safe and natural products for health and for specific areas like skin or hair care are some of the major drivers,” says Dr Narendra Bhatt, Consultant Ayurveda – Research and Industry. The belief that what’s natural is usually safe, is also promoting the use of herbal excipients. Hence, instead of using synthetic excipients which would further add to the toxicity of drugs, several pharma companies are gradually shifting to herbal excipients.
Dr Dilip Ghosh, Regulatory and Projects, SOHO – Flordis International, International Speaker, Facilitator and Author, also lists some of the drivers of herbal excipients market. He says, “The growth of the global market of natural excipients is driven by the factors such as growing demand of functional natural excipients, increasing demand of generics, and emergence of new excipients in the market. The availability of cheap labour, skills in abundance and comparatively lower cost of the raw materials will drive this industry. Industry is looking for natural alternatives, particularly to reduce drug-induced toxicity. Herbal excipients like cyclodextrin have natural, complex structure which are their unique selling points.”
Excipients’ have multiple roles to play as diluents, binders, disintegrants, adhesives, glidants and sweeteners in tablets and capsules. According to industry experts, herbal excipients can definitely equipped to take over these functions from synthetic excipients. Besides being low on toxicity, herbal excipients also provide cost advantages, thereby making their position stronger in the market. Ghosh sheds more light on this issue. He says, “A number of natural gums and mucilages have been investigated for inclusion in pharma formulations in novel drug delivery systems (NDDS) such as modified release dosage forms and delivery systems that target specific sites of delivery. NDDS is one of the innovative technologies under development for targeted delivery to specific organ/s. Several natural products such as Cyclodextrin, Carrageenan, Chitosan and Shellac are used in different encapsulated delivery systems.”
Thus, spurred by the need for safer medicines, the herbal industry is registering steady growth. But, there are many hurdles to overcome too.
Challenges to tackle
Though being natural is the biggest plus point of herbal excipients, their adoption has not been widespread. There is a need for more awareness, research and verifications to pave the way for their more effective use.
Dr Vijay Singh Chauhan, Consultant to Ayurvedic pharma industry, and Scientific Advisor, Sunwave Pharma, Romania, says, “As far as ayurvedic/ herbal/ dietary supplement markets are concerned, till now, universally accepted pharmacopoeial excipients are used. Herbal excipients are still under testing in various research labs.”
“The biggest challenge is availability,” asserts Bhatt. He adds, “With increasing demands and use, I wonder what situation will develop soon if efforts are not made to cultivate and develop natural resources.”
One view is that herbal excipients do offer more benefits than synthetic excipients, but, it is of no use till such excipients are accepted by the authorities of various pharmacopoeias for ayurvedic proprietary products. This global acceptance will happen only if these excipients fulfill the scientific requirements laid down by various pharmacopeia.
Ghosh says, “There is no extensive research on herbal excipients, particularly in nano-technology area. There is also no big industry funding as well as government initiatives. Very limited cGMP (pharma-grade) manufacturing facility and contamination is also an issue.”
In the past, on numerous occasions herbal products have come under fire due to presence of contaminants like heavy metals. Will the use of herbal excipients in medicines exacerbate this issue and pose regulatory problems for the drug manufacturers, especially during the exports? If yes, then it is yet another challenge to be tackled.
The industry seems to be divided on this issue
Ghosh says, “Increasing soil and air pollution and higher level of heavy metals/ pesticides/ residues are major hurdles of India herbal excipients for export market.”
However, Chauhan says, “This question has no relevance till metal – based excipients come into use, which is not the case as of now! Heavy metals, viz. lead, mercury, arsenic and cadmium have been tested and found toxic by the scientists world over, hence their maximum permissible limits have been worked out and norms laid down!”
It’s a fact that regulatory issues are mainly debated when it comes to the export part of the business. If the industry shows a similar approach when drugs are distributed within the country then it will definitely raise its own standards.
Bhatt believes that the use of herbal excipients might actually help to raise the standards of the industry. He says, “Rather it will help. One question I have is why do we think of only exports when it comes to safety. The fact is we should address these issues in a more logical and rational manner rather than only for trade gains. It will help us evolve our own parameters, take on challenges and provide sustainable growth, and not only opportunistic growth.”
He adds, “Nobody predicted that the herbal extracts market would grow so fast in a decade. But we must understand and accept that it was at the cost of value added formulations. We failed to get into value added formulations due to lack of scientific and technical efforts. I am afraid, it might happen again in excipients if proper care is not taken.”
Amidst the debate over possible contamination in the herbal excipients and regulatory hurdles arising due to it there is a promising development as well.
Dr Vandana Patravale, Professor of Pharmaceutics, Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Mumbai, informs, “The newer versions of herbal pharmacopoeia however in their monographs include limits for the heavy metal content etc. Adhering to the said limits can function as a reliable measure to use and control herbal excipients.”
Sustaining the growth momentum
The global excipient market is growing consistently and is predicted to maintain the upward trajectory, however, on the other hand, the herbal excipient segment is yet at a very nascent stage of growth. The pharma industry is well aware and optimistic about the potential that this segment holds but as scientifically proven theories constitute the core of the pharma business, herbal excipients will have to prove themselves on the same parameters.
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