From concept to shelf, the rambutan rind has been developed by SIRIM into a first of its kind anti-fungal cream from natural sources
THE RAMBUTAN rind has proven its worth in the cosmeceutical industry, going from waste to an award-winning product. The innovators discuss their journey from research to commercialisation and beyond.
At the International Innovation & Technology Exhibition (ITEX) 2019, one of SIRIM’s discoveries, a natural bioactive dermatocide anti-fungal cream created with rambutan rind extract, won the Gold Medal and Best Invention Award. This cream is the first of its kind to contain active components derived from natural sources.
It took a lot of hard work. After performing aqueous and solvent extractions on diverse herbal waste materials, the SIRIM team discovered numerous extracts with excellent antioxidant and antifungal characteristics. Rambutan rind was one of them.
Thavamanithevi Subramaniam, a Senior Researcher at SIRIM’s Industrial Biotechnology Research Centre (IBRC), who lead the team working on this, said:”We opted for the rambutan rind because it is easily available locally. An added plus is that the extract is made from fruit scraps!” Other members of the team were Sarifah Rejab, Dr M Theanmalar, Adida Zuraida, Aidawati Shabery and Dahlia Daud.
The team chose to formulate the anti-fungal cream in-house, using SIRIM’s Good Manufacturing Practice (GMP) certified facilities after receiving positive results. “All of the tests were carried out in accordance with the requirements of the Organisation for Economic Co-operation and Development (OECD) and ISO 17025,” added Senior Researcher and colleague Dr Theanmalar Masilamani.
In 2017, this antifungal cream formulation based on rambutan waste bioactives was patented.The National Pharmaceutical Regulatory Agency (NPRA) has yet to register the product. On Aug 17, 2018, IBRC submitted an application for Traditional Medicine Classification for higher product benefit claim purposes.
This is SIRIM Berhad’s first Research & Development (R&D) product to be successfully approved for MAL under Traditional Medicine. Because all ingredients/excipients and the active ingredient utilised in the composition of the cream must be registered with the NPRA, the Traditional Medicine registration process took nearly two years.
With the registration number MAL 20106148TC, the product has now been registered with NPRA as a Traditional Medicine.
Meanwhile, a company called Zarra Zafeena Resources (ZZR) has begun the commercialisation process. ZZR will perform a market trial of this product under the name BioNephegen Skin and Nail Cream prior to full commercialisation.
SIRIM Tech Venture Sdn Bhd (STV) appointed ZZR to participate in the BioNephegen Skin and Nail Cream Market Trial Program. In December 2020, STV and ZZR signed a Trial & Evaluation Agreement (TEA) to gather data and information on market demand, acceptance, and practicality of the product before it is permanently licenced.
This programme is critical for determining the product’s marketability and gauging full acceptability by potential customers. STV went through a rigorous screening procedure to find the right company for this programme.
ZZR was chosen due to its financial and legal position, extensive experience in selling personal care goods and strong commitment throughout the programme, among other factors.
The rambutan rind extract has proven itself to have numerous helpful effects from the start, with preliminary in-house efficacy testing yielding positive results, particularly for athlete’s foot, scaly and diseased nails and insect bites.
The product’s multi-spectrum efficacy against skin fungal and yeast (Candida Albicans) infections is a standout feature. This means that a single extract can combat a variety of dermatophytes that cause skin problems.
A secure product
“Most commercial treatments are steroid chemicals that only work on certain fungi,” says Dr Theanmalar. This offers a wider range of applications, as well as synergistic benefits and is non-toxic. It is also anti-inflammatory and beneficial for itching and insect bites.”
“It has also been tried for eczema and appears to perform well, reducing redness and dryness,” said Adida Zuraida Mohamad, a Microbiologist at SIRIM’s IBRC.
The extract is safe to use, even for youngsters, because it is generated from a natural resource. “In fact, unlike other eczema creams, parents want to use this for their young children with eczema because it doesn’t irritate their loved ones’ skin,” she explained.
Since its introduction, the anti-fungal lotion has been well-received. “Many of our colleagues said that this product worked well for them and continued coming back for more when we were doing in-house efficacy evaluations,” Thavamanithevi shared.
“Since then, the company that has adopted the product has stated that they have received return customers.”
SIRIM is gearing up to further enhance the product and expand its reach, inspired by the good response and awards earned. It has already applied to the NPRA for a MAL ‘Traditional Medicine’ registration number, which will allow the medicine to be sold in clinics.
On par internationally
Malaysia’s capabilities, according to Thavamanithevi, Dr Theanmalar and Adida, are comparable to those globally.
“When we began anti-oxidant investigations in 2006, SIRIM was the first to look into the possibilities of exploiting rambutan rind. Subsequently, countries like Australia, Canada and Vietnam started studying the usage of rambutan rind for cosmetic products,” explained Thavam.
As a result, there is a lot of room for expansion in this field. “Malaysian research institutes and universities have extensive R&D capabilities.
“We have plenty of natural resources and a pool of talent with multidisciplinary expertise capable and equipped to discover and achieve excellent scientific results.”
She said that besides that, proper funding to support research activities in producing potent bioactives from Malaysia’s natural resources was crucial.
‘Therefore, SIRIM welcomed collaboration with industries and other research institutes to explore potent bioactives from Malaysia’s natural resources,” explained Sarifah. — The Health
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