Objective: To evaluate the safety and efficacy of Blumea balsamifera (L.) DC for the treatment of urinary tract stones. Methods: Data were collected from online databases, the Philippine National Library, and unpublished clinical trials. We obtained permission from authors of unpublished clinical trials but with existing patent applications. Studies were selected based on the criteria: randomized controlled trials (RCT) on the efficacy of Blumea balsamifera (L.) DC for the treatment of urinary tract stones given alone or in combination with a non-pharmacological/pharmacological intervention in comparison to a pharmacological/non-pharmacological intervention for urinary tract stones with participants aged 15 to 65 years in an ambulatory setting. Results: Our search methods yielded a total of 20 studies. Four studies met our inclusion criteria. Patients who took sambong had a reduction in stone size by radiographic evidence 23.45 times more than those who took the placebo (p=0.001). Also, patients taking sambong were 38.04 times more likely to pass stones compared to those patients taking a placebo (p=0.0004). Patients taking sambong were 7.48 times more likely to have reduction or disappearance of signs and symptoms compared to the placebo group (p=0.008). Conclusions Sambong treatment is effective in treating patients with urolithiasis by radiographic evidence of a decrease in size and/or number of stones, the passage of stone/s and/or disappearance or reduction of signs and symptoms with no serious adverse events.
Urinary Calculi

Quercetin, a flavonoid compound which is widely distributed in plants are considered ass beneficial physiologically due to attributed bioactivity such as anti-cancer, immunomodulatory, antidiabetic, and anti-inflammatory. In this study, the quercetin content from the dried Blumea balsamifera L. DC dried leaf was macerated with 95% ethanol and the concentrated extract was purified using Modified Kupchan method and flash chromatography. All fractions were tested for the presence of flavonoids using phytochemical screening and the selected dichloromethane fraction were further purified using another round of flash chromatograph. All resulting fractions and pooled samples were tested for the antioxidant property using the developed Thin Layer Chromatography (TLC)-Bioautography and separated compounds were derivatized with DPPH. Using the optimized TLC-Bioautography method, the quercetin content in the dichloromethane fraction was analyzed and compared with a reversed phase high performance liquid chromatography hyphenated with photodiode array detector (RP-HPLC-PDA). The calculated quercetin content from the pooled sample using TLC-bioautography method is 2.25 mg/ml and from RP-HPLC-PDA is 2.02 mg/ml which was not comparable statistically using unpaired t-test (p<0.05, α=0.05
Quercetin

OBJECTIVES

The aim of this study is to describe the pharmacologic activities of Yerba buena (Mentha x villosa Huds).

METHODS

Data were collected if available from online databases from 1950 to 2023 as well as the Philippine National Library, and unpublished clinical trials.

RESULTS

The initial search yielded thirty-seven studies from the different databases. After further screening, eighteen studies met the inclusion criteria. In vitro/in vivo studies of yerba buena showed antihypertensive, antibacterial, anthelmintic, antitumor, antiviral, and analgesic activities. Safety studies conducted showed that yerba buena possesses antimutagenic property. Clinical trial of yerba buena showed that oral administration of yerba buena and Paracetamol produced comparable analgesic efficacy.

CONCLUSION

The medical benefits of yerba buena have been well-documented and thoroughly researched. Yerba Buena was reported to have analgesic, antibacterial, anthelmintic, anticancer, antiviral, and antihypertensive properties. Among all the different activities, its analgesic activity was the only reported pharmacologic indication to have been clinically tested.

Objectives: The Bioavailability/Bioequivalence Unit (BA/BE Unit) of the Department of Pharmacology and Toxicology, College of Medicine, University of the Philippines Manila which has not been operational since 2012, is due for renewal of its accreditation. To date, there are only three Philippine Food and Drug Administration-accredited laboratories that perform bioequivalence studies in the Philippines. One of the prerequisites of registering specific generic medicines is the conduct of Bioequivalence (BE) studies which are performed to ensure that the generic drug is at par with the innovator drug. Thus, this study aimed to determine the feasibility of re-establishing the BA/BE Unit as a bioequivalence testing center. Methods: The feasibility study done is a qualitative descriptive analysis based on expansive literature review and performance of SWOT analysis within the BA/BE unit. Literatures were selected based on its assessed relevance to the study. The databases checked were PubMed and Google Scholar. The terms used were from the Medical Subject Heading (MeSH) including feasibility studies, therapeutic equivalency, and generic drugs. Literature review was performed on the factors affecting the four types of feasibility studies (market, technical, financial, and organizational). A SWOT analysis of the BA/BE Unit was done through the review of records and documents of previous BE studies and focus group discussion among the BA/BE Unit team members. Results: The BA/BE Unit conducted 24 bioequivalence studies from 2006-2009 and still receives inquiries from drug companies. It implements its QMS throughout the pre-analytical, analytical, and post-analytical stages of the workflow. Its organizational structure consists of qualified professionals with updated GCP and GLP certificates. Because of the adequately equipped facility, lower honoraria for government-employed personnel, and lower expenses for laboratories and in-patient admissions, the cost of conducting a bioequivalence study in the BA/BE Unit will be lower than in other BE centers. Conclusion Based on the SWOT analysis and market, technical, financial, and organizational considerations, reestablishing the BA/BE Unit as a bioequivalence testing center is feasible.
Feasibility Studies ; Therapeutic Equivalency ; Drugs, Generic

OBJECTIVES

In response to the need for a simple and fast way of ensuring that generic drugs especially those that contain rifampicin are bioequivalent with reference drugs, this study validated an ultra-high-performance liquid chromatography (UHPLC) method of quantifying rifampicin in human plasma. The study also validated the method's selectivity, linearity, sensitivity, accuracy, precision, and the absence of a carry-over effect adhering to the Philippine Food and Drug Administration guidelines.

METHODS

Plasma samples were prepared via protein precipitation using methanol containing ascorbic acid. Three microliters (3 uL) of the prepared samples were then analyzed in a Waters Acquity H-Class UPLC® system coupled to a tunable ultraviolet (TUV) detector with an attached UPLC® BEH C-18 column using a developed and optimized method. Briefly, the column temperature was set to 40°C and the sample temperature was set to 10°C. Elution was done using a linear gradient flow of a water-acetonitrile mixture that started with 45% acetonitrile increasing to 60% acetonitrile at 0.5 minutes and back to 45% acetonitrile at 3 minutes and having a constant flow rate of 0.5 mL/min. Detection was done at 340 nm. Method validation was performed following the ICH guidelines for Bioanalytical Method Validation, the same guidelines referenced by the ASEAN Guideline for Harmonisation of Standards and the Philippine Food and Drug Administration (FDA).

RESULTS

The method had an analysis time of 3 minutes wherein rifampicin eluted at 1.4 minutes while the internal standard, rifapentine (IS) eluted at 1.7 minutes. Since no co-eluting endogenous materials were observed for the rifampicin and the internal standard, the method was confirmed to be selective. Its linearity over the range of 2 ug/mL to 25 ug/mL has been validated where it has a limit of detection (LOD) and limit of quantification (LOQ) values of 0.64 ug/mL and 1.94 ug/mL, respectively. The interday and intraday precision, reported as % coefficient of variance (%CV), and interday and intraday accuracy, reported as %error all within the limits of ±20% for the LLOQ and ±15% for the rest indicating its reliability and reproducibility. Lastly, due to the nature of the injection of the sample into the system, wherein a blank immediately follows the highest concentration standard, the method has been cleared of a carry-over effect.

CONCLUSION

The study successfully validated a UHPLC method of quantifying rifampicin in human plasma. Due to the sample processing method used and the chromatographic conditions set, the method can prepare and analyze samples in a simple yet fast, sensitive, reliable, and reproducible manner. The method can be applied in bioavailability and bioequivalence studies of rifampicin.

Human ; Rifampin ; Rifampicin ; Bioequivalence ; Therapeutic Equivalency