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Research Details

Research Title Formulation of Dosage Forms from Standardized Non-Toxic Bioactive Extracts from Indigenous Plants
Researcher(s) Shirley C. Agrupis, Anabelle B. Alejo, Kristian Gay D. Beltran, Maingelline B. Vivit, Riena Kristen Agustin
Research Category Project
Research Status continuing
Duration May 15, 2020 to May 14, 2023
Commodity Medicinal Plants
Research Site(s) Tuklas Lunas Development Center
Source of Fund(s) PCHRD
Brief Description
The project is a continuation of the program entitled “Development of Anti-inflammatory Herbal Products from Iluko Indigenous Plants” which started in 2018. Project 1 (2018-2019) evaluated the anti-inflammatory activity of the extracts from eleven (11) plant species indigenous in Ilocos Norte using primary and orthogonal assays and the determination of their toxicity profile in vitro.

In this project, five (5) plants were prioritized for the standardization and formulation of herbal dosage forms utilizing only the leaf parts, these include MMSU-0001, MMSU-0007, MMSU-0024, MMSU-0031, and MMSU-0034. These indigenous plants showed good potential for development into herbal drugs, based on their safety profile and bioactivity in orthogonal assays. Of which, MMSU-0001, MMSU-0024, and MMSU-0031 have dual COX/LOX inhibition activities with COX ratios (COX-2/COX-1) of 1.27, 1.10 and 1.06 and LOX percent inhibitions of 98.22, 76.47, and 113.37%, respectively. Dual COX/5-LOX inhibitors are potential new drugs to treat inflammation. They act by blocking the formation of both prostaglandin and leukotrienes. They offer an excellent preclinical gastrointestinal pharmacological safety profile. It is therefore expected that dual inhibitors induce an enhanced anti-inflammatory effect without damaging the gastrointestinal mucosa. Meanwhile, MMSU-0007 and MMSU-0034 are COX-2 specific inhibitors with COX ratios (COX-2/COX-1) of 1.42 and 1.25, respectively. COX-2 is an important mediator of pain and inflammation. COX-2 specific inhibitors, raises the possibility of relieving pain and inflammation with reduced risk of gastrointestinal complications. This now presents a major advance in the treatment of inflammatory related disorders such as rheumatoid arthritis and osteoarthritis. Moreover, MMSU-0031 obtained a highest bioactivity with Top tier 1 classification in inhibiting COX-2 transcription through COX-2 transcriptional status cell-based assay.

This project shall advance to the development of standardized dosage forms of the five (5) indigenous plants utilizing spray-dried extracts. The standardization process will be done in collaboration with Pascual Laboratories, Inc. The standardized extracts shall progress to formulation of standardized, safe, and effective herbal products with anti-inflammatory activity in tablet and in capsule dosage forms. In addition, the formulation of topical dosage forms in cream, ointment and gel will also be included. The results of the study will then offer opportunity to market an affordable herbal drug or herbal supplement that meets the specifications and standards to ensure quality, safety, and efficacy set by the World Health Organization (WHO) and the Food and Drug Administration (FDA). In addition, a new industry will flourish in creating new jobs in agriculture, posing additional income to local farmers who will provide and process the raw materials and manufacturing of herbal products.

Expected Output
Publication: At least one published article from the
                            project

Products: Standardized herbal tablet or capsule and 
                       standardized topical dosage forms

People and Services: - Trained personnel in spray
                                               drying techniques and
                                               standardization process of
                                               bioactive and non-toxic extracts
                                            - Established skill of personnel in 
                                                dosage formulation of herbal
                                                medicine
                                            - Established assays for COX and 
                                               LOX in MMSU-TLDC
                                            - Refurbished TLDC with
                                               laboratory equipment used in 
                                               formulation studies

Abstract Not Available