1.In vitro bioequivalence analysis of generic metformin hydrochloride film-coated tablets.
Zsarie P. BUENAVIDEZ ; Althea Kathleen P. BRUM ; Krizia Marie T. MANZO ; Zenia Luisa M. MORA ; Perlita M. CRUCIS ; April Mergelle R. LAPUZ ; Kevin Jace A. MIRANDA ; Rogie Royce Z. CARANDANG
Acta Medica Philippina 2025;59(Early Access 2025):1-9
BACKGROUND AND OBJECTIVES
The in vitro bioequivalence assessment using a dissolution apparatus, as specified by the United States Pharmacopeia (USP), is a critical parameter in the formulation and development of generic pharmaceutical products. This study is crucial for evaluating the interchangeability of generic drugs with their reference innovator counterparts. Post-market surveillance of generic drugs ensures consistent quality after distribution in the market. Metformin hydrochloride, a widely prescribed oral hypoglycemic agent for managing type 2 diabetes, is among the most utilized medications globally.
In the Philippines, there is a growing need to assess the bioequivalence of various generic formulations of metformin HCl f ilm coated tablets to ensure compliance with regulatory requirements. The Philippine Food and Drug Administration (FDA) mandates in vivo or in vitro bioequivalence including, dissolution profile comparison, as a prerequisite for the registration of generic drugs. This study aims to evaluate the quality and in vitro bioequivalence of metformin HCl f ilm-coated tablets available in the Philippine market by comparing their dissolution profiles against the innovator, Glucophage. This research seeks to provide insights into the interchangeability, therapeutic equivalence, and overall quality of these generic formulations, thus contributing to public health and regulatory standards.
METHODSGeneric metformin HCl film-coated tablets were subjected to quality control tests, including weight variation, thickness and diameter, hardness, friability, and disintegration tests, in accordance with USP guidelines. To assess in vitro bioequivalence, dissolution testing was performed, and the concentration of the dissolved drug was determined using a microplate assay reader to measure absorbance. Dissolution profiles of the generic metformin HCl film-coated tablets were compared to that of the innovator drug, Glucophage to evaluate bioequivalence.
RESULTSAll tested generic metformin HCl film-coated tablets complied with USP specifications for quality control tests, except for the hardness test, where three brands failed to meet the required standards. While for dissolution testing, five out of six generic brands demonstrated acceptable dissolution profiles and were bioequivalent to the innovator drug Glucophage. However, one brand (Brand A) failed to meet the bioequivalence criteria, exhibiting a dissolution profile outside the acceptable limits.
CONCLUSIONThis study demonstrates that most generic metformin HCl film-coated tablets available in the Philippine market meet the United States Pharmacopeia (USP) quality control requirements and exhibit in vitro bioequivalence with the innovator drug. However, the failure of three brands to meet the hardness specifications and the lack of bioequivalence in one brand highlight the need for stringent quality assurance and regulatory oversight. Ensuring compliance with these standards is critical to maintaining the safety, efficacy, and therapeutic interchangeability of generic drugs. These findings emphasize the importance of continuous post-market surveillance to uphold the quality of generic medications in the market, to safeguard public health.
Metformin Hydrochloride ; Metformin
2.Detection and characterization of novel respiratory viruses among native ducks (Anas luzonica) in Central Luzon, the Philippines
Milagros R Mananggit ; Joely T Ongtanco ; Xandre D Baccay ; Ronnie Domingo ; Mary Elizabeth Miranda ; Romeo Gundran ; Dan Drexel dela Cruz ; Frank YK Wong ; S Gabrielle Cody ; Laura A Pulscher ; Emily R Robie ; Emily S Bailey ; Gregory C Gray
Western Pacific Surveillance and Response 2025;16(2):23-28
Objective: This cross-sectional, prospective surveillance study sought to determine the prevalence of novel respiratory viruses among domestic ducks in Central Luzon that are known to have frequent contact with wild avian species. Such contact may lead to novel virus spillover events that may harm domestic poultry as well as humans.
Methods: From March 2019 to January 2020, cross-sectional and prospective surveillance for viruses among domestic ducks (Anas luzonica) was conducted by periodically collecting oropharyngeal swabs from ducks on 54 farms across three municipalities within Central Luzon (Region III). A flock of 30 sentinel domestic ducks was also sampled four times after being confined in the Candaba swamp. The resultant 1740 swab samples were pooled (5 samples/pool, 348 pools) by site and screened with molecular assays for respiratory viruses from multiple viral families.
Results: Two farms yielded samples positive for avian influenza virus in Candaba, where adolescent ducks are known to freely mix with wild birds as they graze in rice fields. Overall, the prevalence of avian influenza virus was 2.3% (8/348 pools). Sequencing revealed three pools with highly pathogenic avian influenza H5N6, one with low pathogenicity H5N8, and one with H5 with an unspecified neuraminidase. All the pooled specimens tested were negative for influenza C, adenoviruses, coronaviruses and enteroviruses.
Discussion: Although this study had several limitations, it found supportive evidence that domestic ducks are acquiring avian influenza viruses from wild bird species. These findings underscore recommendations that duck farmers should seek to prevent domestic ducks from mixing with wild avian species.
3.War on drugs in the Philippines: Evaluating fear appeals as antidote to continued drug use.
Marie Diane Y. MONSADA ; Laurie S. RAMIRO ; Andrea B. MARTINEZ ; Gaea Marelle J. MIRANDA ; Jan Zsanila D. ESTACIO ; Rowalt C. ALIBUDBUD ; Leonardo R. ESTACIO JR.
Acta Medica Philippina 2025;59(14):132-144
OBJECTIVES
This study aimed to assess the effectiveness of fear-based strategies on the decisions of Filipino drug users to surrender to authorities under the Philippine government's anti-drug policy. It also examined the influence of these scare tactics on the discontinuance of drug use among drug surrenderers. The fear appeals included community shaming and threats of imprisonment, torture or death under Oplan Tokhang launched by the Philippine government in 2016.
METHODSA combination of survey questionnaires and in-depth interviews was conducted with 56 surrenderers from selected communities in Marikina City, Metropolitan Manila. These individuals participated in a series of communitybased activities, including dance therapy (referred to as ‘Zumba’), Bible study and other religious activities, seminars on the dangers of drugs, and livelihood training programs. Readiness to change and levels of self-efficacy were measured after several months of participating. The effectiveness of fear appeals was further evaluated through actual drug testing.
RESULTSThe results indicated that 82.1% of the 56 drug users voluntarily surrendered to authorities while the rest claimed to have been pressured by family, friends, police, religious persons, or local officials. The primary motivations for surrender included fears of being killed or jailed, and a desire for rehabilitation. Readiness to change was generally high, but levels of self-efficacy were mixed. Out of the 56 drug surrenderers, only 37 underwent drug testing, where 40.5% tested positive even after months of participating in the community rehabilitation program.
CONCLUSION AND RECOMMENDATIONThe findings showed that scare tactics were effective in encouraging or forcing drug users to surrender to local authorities. However, their effectiveness in preventing continued drug use was inconclusive. Structural weaknesses in community rehabilitation policies and programs were identified. Over time, the initial fear-inducing impact of the scare tactics diminished as surrenderers became desensitized. Recommendations for enhancing the efficacy of the government’s anti-drug campaign were provided.
Human ; Philippines ; Drug Users
4.Risk factors and onset of illicit drug use among Filipino youth: A cross-sectional analysis of sociodemographic and environmental influences.
Enrico U. BAULA ; Kim Ronaline B. SALVADOR ; Laurie S. RAMIRO ; Andrea B. MARTINEZ ; Gaea Marelle J. MIRANDA ; Jan Zsanila D. ESTACIO ; Rowalt C. ALIBUDBUD ; Leonardo R. ESTACIO JR.
Acta Medica Philippina 2025;59(14):145-155
BACKGROUND AND OBJECTIVES
The drug problem in the Philippines is influenced by various factors, but research on the specific risk factors and onset of drug use—an early predictor of severe drug abuse—is limited. This crosssectional study aims to identify factors associated with the onset of illicit drug use, focusing on variables such as sex, perceived socioeconomic status, adverse life events (including physical, verbal, and sexual abuse, and bullying), adverse home environments (like family substance abuse and parental separation), and premorbidities (such as anxiety and depression). Understanding these factors is crucial since early drug use often predicts more severe abuse later.
METHODSThis cross-sectional study involved 354 participants aged 7 to 34 years, all undergoing rehabilitation for at least three months. Data were collected through self-administered questionnaires at their rehabilitation centers. Regression analysis was used to examine the relationship between the onset of drug use and the identified risk factors.
RESULTSRegression analysis revealed that, apart from premorbidities, all the examined factors were significantly correlated with the onset of drug use. Specifically, being male, having higher affluence, experiencing more adverse life events, and living in a more adverse home environment were associated with an earlier onset of drug use. Among these factors, adverse life events and home environment were the strongest predictors of the onset of illicit drug use, while premorbidities did not show a significant relationship with drug use onset.
CONCLUSIONThe study highlights that sex, socioeconomic status, adverse life events, and home environment are significant in the early onset of drug use, while premorbidities are not. Early intervention should focus on these key risk factors. A risk-focused approach, guided by biopsychosocial perspectives, is recommended. Targeted interventions should address adverse life events and home environments to prevent early drug use and subsequent abuse effectively.
Human ; Risk Factors ; Home Environment
5.Surveillance for respiratory viruses in freshwater bodies visited by migratory birds, the Philippines
Romeo S Gundran ; Dan Drexel Dela Cruz ; Milagros R Mananggit ; Joely T Ongtangco ; Xandre D Baccay ; Ronnie D Domingo ; Mary Elizabeth G Miranda ; Emily Bailey ; Samantha Gabrielle Cody ; Laura A Pulscher ; Emily R Robie ; Gregory C Gray
Western Pacific Surveillance and Response 2024;15(3):04-08
In this report, we sought to demonstrate that freshwater sampling for migrating bird-associated novel respiratory virus incursions is possible and more desirable than the alternative approach of capturing and swabbing wild migrating birds. Freshwater sampling should be considered as an alternative approach for pre-pandemic pathogen surveillance.
6.Is satisfaction with the medication provisions of the Senior Citizens Act and frequency of senior identification card use associated with medication compliance among hypertensive patients in the Philippines?
Nativity R. Labbao ; Mary Kriznah S. Hidalgo ; Ram Joseph D. Doroliat ; Daisy-Mae Alegado-Bagaoisan ; Kevin Jace A. Miranda ; Royce Z. Carandang
Acta Medica Philippina 2024;58(Early Access 2024):1-8
Background:
Long-term treatment and medication compliance are critical for managing conditions like hypertension, yet only 20% of cases are well-controlled, mainly due to socioeconomic factors. The Expanded Senior Citizens Act of 2010 offers a 20% discount on medications to improve compliance, but many seniors need to be made aware of these benefits. Evaluating satisfaction with the Act, specifically regarding its medication-related provisions, is essential for enhancing compliance and health outcomes among senior citizens.
Objective:
This study examined the association between satisfaction with the medication provisions of the Senior Citizens Act, the frequency of senior identification card usage, and medication compliance among hypertensive patients.
Methods:
We conducted a community-based cross-sectional study with 458 hypertensive senior citizens in Dasmariñas City, Cavite, Philippines. Senior citizens were randomly selected and completed a survey using a validated, self-developed questionnaire and the Hill-Bone High Blood Pressure (HB-HBP) compliance scale. We performed linear regression analysis to examine the association between their satisfaction and the use of senior citizens’ benefits on their medication compliance.
Results:
Senior citizens were 60-88 years old (mean 69; standard deviation [SD] 5.9). Thirty-eight percent were satisfied with the Senior Citizens Act and 49% regularly used their senior citizen card. Senior citizens scored an average of 46.82 (SD 4.96) on the HB-HBP compliance scale (possible range = 14-56), indicating high compliance. Those dissatisfied with the Senior Citizens Act were less compliant with their antihypertensive medications [B (unstandardized beta) = -1.65, 95% CI (Confidence Interval) = -2.70, -0.61]. Similarly, those who rarely or never used their senior identification cards (B = -1.54, 95% CI = -2.61, -0.48) and those who used them occasionally (B = -1.43, 95% CI = -2.57, -0.29) showed lower medication compliance compared to those who used them regularly.
Conclusion
Senior citizens who are satisfied with the medication provisions of the Act and regularly use their senior identification cards exhibit higher compliance with their antihypertensive medications than those with lower satisfaction and infrequent card usage. Interventions should prioritize educational sessions to inform senior citizens about the benefits of the Senior Citizens Act, including how to use their identification cards to access medication discounts effectively.
Human
;
hypertension
;
medication adherence
;
Philippines
;
satisfaction
;
personal satisfaction
7.Granulomatous amebic encephalitis in a patient treated with chemotherapy: a case report and literature review
Marcos R. FLORES ; Miranda G. MONTION ; Aneesha N. USMAN ; Munachiso A. NGENE ; Samir RUXMOHAN
Journal of Neurocritical Care 2024;17(2):88-93
Background:
Granulomatous amebic encephalitis (GAE) is caused by Acanthamoeba species or Balamuthia mandrillaris, which are microscopic, free-living amoebas found worldwide. People with compromised immune systems are at an increased risk of fatal cerebral infection caused by Acanthamoeba species, whereas B. mandrillaris can affect both immunocompromised and immunocompetent patients. Infections can involve the central nervous system causing GAE.Case Report: A 71-year-old Caucasian woman, previously diagnosed with chronic lymphocytic leukemia and undergoing chemotherapy, arrived at the emergency department exhibiting seizure-like symptoms. Brain imaging revealed bilateral cerebral masses with central necrosis and hemorrhage, among other findings. The patient underwent a biopsy and was diagnosed with GAE.
Conclusion
Unfortunately, even with the correct diagnosis, GAE leads to rapid deterioration and a higher risk of mortality. This case demonstrates the rapid and severe nature of GAE and emphasizes the need for ongoing studies and better treatment options to improve GAE outcomes.
8.Granulomatous amebic encephalitis in a patient treated with chemotherapy: a case report and literature review
Marcos R. FLORES ; Miranda G. MONTION ; Aneesha N. USMAN ; Munachiso A. NGENE ; Samir RUXMOHAN
Journal of Neurocritical Care 2024;17(2):88-93
Background:
Granulomatous amebic encephalitis (GAE) is caused by Acanthamoeba species or Balamuthia mandrillaris, which are microscopic, free-living amoebas found worldwide. People with compromised immune systems are at an increased risk of fatal cerebral infection caused by Acanthamoeba species, whereas B. mandrillaris can affect both immunocompromised and immunocompetent patients. Infections can involve the central nervous system causing GAE.Case Report: A 71-year-old Caucasian woman, previously diagnosed with chronic lymphocytic leukemia and undergoing chemotherapy, arrived at the emergency department exhibiting seizure-like symptoms. Brain imaging revealed bilateral cerebral masses with central necrosis and hemorrhage, among other findings. The patient underwent a biopsy and was diagnosed with GAE.
Conclusion
Unfortunately, even with the correct diagnosis, GAE leads to rapid deterioration and a higher risk of mortality. This case demonstrates the rapid and severe nature of GAE and emphasizes the need for ongoing studies and better treatment options to improve GAE outcomes.
9.Granulomatous amebic encephalitis in a patient treated with chemotherapy: a case report and literature review
Marcos R. FLORES ; Miranda G. MONTION ; Aneesha N. USMAN ; Munachiso A. NGENE ; Samir RUXMOHAN
Journal of Neurocritical Care 2024;17(2):88-93
Background:
Granulomatous amebic encephalitis (GAE) is caused by Acanthamoeba species or Balamuthia mandrillaris, which are microscopic, free-living amoebas found worldwide. People with compromised immune systems are at an increased risk of fatal cerebral infection caused by Acanthamoeba species, whereas B. mandrillaris can affect both immunocompromised and immunocompetent patients. Infections can involve the central nervous system causing GAE.Case Report: A 71-year-old Caucasian woman, previously diagnosed with chronic lymphocytic leukemia and undergoing chemotherapy, arrived at the emergency department exhibiting seizure-like symptoms. Brain imaging revealed bilateral cerebral masses with central necrosis and hemorrhage, among other findings. The patient underwent a biopsy and was diagnosed with GAE.
Conclusion
Unfortunately, even with the correct diagnosis, GAE leads to rapid deterioration and a higher risk of mortality. This case demonstrates the rapid and severe nature of GAE and emphasizes the need for ongoing studies and better treatment options to improve GAE outcomes.
10.A life‑threatening benign vascular lesion of the uterus, cavernous hemangioma: A case report
Maria Lalaine Aviles Miranda ; Eleyneth Ilagan Valencia
Philippine Journal of Obstetrics and Gynecology 2023;47(5):283-290
The objective of this clinical report is to present the first local case of rare cavernous uterine
hemangioma. This is a case of a 28‑year‑old G2P1 (1001) during her first trimester of pregnancy
who was admitted to our institution for the second time due to profuse vaginal bleeding and
severe anemia. The transvaginal scan revealed an embryonic demise of 8 weeks age of gestation
noted at the endocervical canal. There is a posterofundal heterogeneous mass measuring
6.3 cm × 5.7 cm × 5.0 cm (volume: 94.2 ml) with multiple cystic spaces, which on Doppler studies
showed abundant vascularity suggestive of uterine hemangioma. Antifibrinolytics were administered.
The patient underwent emergency hysterectomy with bilateral salpingectomy due to profuse
vaginal bleeding with histopathology result of cavernous hemangioma of the uterus. Cavernous
uterine hemangioma is a rare vascular lesion that poses a great challenge in the diagnosis and
management. There were limited published articles regarding cavernous hemangioma of the uterus.
There were conservative treatment options such as uterine artery embolization, the use of hormonal
oral contraception, intralesional glucocorticoid therapy, the use of interferon‑α, laser therapy, and
surgical excision. Hysterectomy is the definitive treatment for intractable bleeding. It is recommended
to establish an international registry for this rare case. The experts in different specialties such as
obstetrician‑gynecologists, interventional radiologists, and vascular surgeons, can also formulate
an algorithm for its diagnosis and treatment.
Case Reports
;
Hemangioma
;
Vascular Malformations


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