130 research outputs found
Dietary polyamines in Mediterranean diet and their health benefits
Get PDFRaymond R Tjandrawinata Dexa Laboratories of Biomolecular Sciences (DLBS), Dexa Group, Tangerang, Indonesia I would like to contribute to the discussion of a publication entitled “Mediterraneandiet and polyamine intake: possible contribution of increased polyamine intake toinhibition of age-associated disease” by Binh et al.1View the original paper by Binh and colleagues
A study on influencers of total sales revenue of generic pharmaceutical companies in Indonesia
Get PDFThis paper empirically examines the influence of firms’ one-year lagged of total new products (t-1), one-year lagged profitability (t-1), and market share of new products to firms’ amount of sales revenue in pharmaceutical generic companies in Indonesia. The data used in this study was panel dataset, gathered from six large pharmaceutical generic companies in Indonesia, during the period 2006 to 2010. The regression analysis method uses fixed effect models, with generalized least squares (GLS) method. The result shows that firms’ one-year lagged of total new product (t-1), one-year lagged profitability (t-1), and market share of new products to be positive and affect significantly the firms’ sales revenue in the pharmaceutical generic companies in Indonesia.Pharmaceutical Generic Companies, Profitability, New Generic Product, Market Share, Sales Revenue
Insulin sensitizer in prediabetes: a clinical study with DLBS3233, a combined bioactive fraction of Cinnamomum burmanii and Lagerstroemia speciosa
No full textAsman Manaf,1 Raymond R Tjandrawinata,2 Desi Malinda1 1Department of Internal Medicine, Faculty of Medicine, University of Andalas, Dr M Djamil Padang Hospital, Padang, 2Dexa Laboratories of Biomolecular Sciences (DLBS), Cikarang, Indonesia Background: The aim of this paper is to evaluate the efficacy and safety of DLBS3233, a novel bioactive fraction derived from Cinnamomum burmanii and Lagerstroemia speciosa, in improving insulin resistance and preserving β-cell performance in patients with impaired glucose tolerance (IGT).Patients and methods: Eighty adult subjects with IGT, defined as 2-hour postprandial glucose level of 140–199 mg/dL, were enrolled in this two-arm, 12-week, double-blind, randomized, placebo-controlled preliminary study. Eligible subjects were randomly allocated to receive either DLBS3233 at a dose of 50–100 mg daily or placebo for 12 weeks. The study mainly assessed the improvement of homeostatic model-assessed insulin resistance (HOMA-IR), the 15-minute and 2-hour plasma insulin levels, and the oral disposition index.Results: After 12 weeks, DLBS3233 improved insulin resistance better than placebo as reflected by a reduced HOMA-IR (-27.04%±29.41% vs -4.90%±41.27%, P=0.013). The improvement of the first- and second-phase insulin secretion was consistently greater in DLBS3233 group than placebo group (-144.78±194.06 vs -71.21±157.19, P=0.022, and -455.03±487.56 vs -269.49±467.77, P=0.033, respectively). Further, DLBS3233 also significantly better improved oral disposition index than placebo. No serious hypoglycemia, edema, or cardiovascular-related adverse events were found in either groups.Conclusion: This study has shown that DLBS3233 at the dose of 50–100 mg once daily was well tolerated, and promisingly efficacious in improving insulin sensitivity as well as preserving β-cell performance in subjects with IGT. Keywords: β-cell function, Cinnamomum burmanii, DLBS3233, Lagerstroemia speciosa, impaired glucose tolerance, insulin resistanc
Anti-inflammatory, antiangiogenic, and apoptosis-inducing activity of DLBS1442, a bioactive fraction of Phaleria macrocarpa, in a RL95-2 cell line as a molecular model of endometriosis
No full textOlivia M Tandrasasmita, Adeline M Sutanto, Poppy F Arifin, Raymond R Tjandrawinata Section of Molecular Pharmacology, Research Innovation and Invention, Dexa Laboratories of Biomolecular Sciences, PT Dexa Medica, Cikarang, West Java, Indonesia Abstract: DLBS1442 is a bioactive fraction extracted from the fruit of the native Indonesian plant, Phaleria macrocarpa (Scheff.) Boerl (Thymelaceae). This bioactive fraction is a potential treatment for dysmenorrhea and endometriosis. The present study investigated the pharmacological action of DLBS1442 in endometrial cells. The effect of various doses of DLBS1442 (0–200 µg/mL) over 24 hours was studied using the human endometrial RL95-2 cell line to observe its effect on angiogenesis, cell migration, estrogen and progesterone receptor levels, the eicosanoid pathway, cell viability, and apoptosis. The impact of DLBS1442 on nuclear factor kappa B (NFκB) and the eicosanoid pathway was also studied through its marker gene expression using a quantitative real-time polymerase chain reaction method. DLBS1442 showed an ability to inhibit angiogenesis and cell migration in a dose-dependent manner. At a dose of 100 µg/mL, DLBS1442 increased the cell population in sub-G1 phase from 7% to 34%. DLBS1442 also significantly downregulated the estrogen receptor level and upregulated the progesterone receptor level. Further, it inhibited the eicosanoid signaling pathway by reducing the NFκB transcription level and subsequent reduction of inducible nitric oxide synthase. A dose-dependent decrease in viability and increased apoptosis in RL95-2 cells were also evident after exposure to DLBS1442, where the IC50 was obtained at around 100 µg/mL. In conclusion, DLBS1442 is a potential agent for alleviating symptoms of endometriosis via its antiangiogenic, anti-inflammatory, and proapoptotic activity. Keywords: progesterone receptor, estrogen receptor, eicosanoid pathway, anti-inflammator
Industri 4.0: revolusi industri abad ini dan pengaruhnya pada bidang kesehatan dan bioteknologi
No full textEkonomi global saat ini sedang pada titik puncak perubahan besar yang sebanding besarnya dengan munculnya revolusi industri pertama atau perkembangan perakitan produksi, atau bahkan penemuan mikrocip. Kemajuan teknologi memungkinkan terjadinya otomatisasi hampir di semua bidang. Sementara itu, kepemilikan perangkat pintar di berbagai bagian dunia mengarah pada tingkat keterkaitan satu sama yang lain yang tak terbayangkan sebelumnya. Di antara berbagai tantangan yang sedang dihadapi dunia saat ini, mungkin yang paling besar adalah bagaimana membentuk Revolusi Industri keempat (disebut juga sebagai Industri 4.0) yang dimulai pada permulaan abad ini. Teknologi dan pendekatan baru yang menggabungkan dunia fisik, digital, dan biologi dengan cara yang fundamental akan mengubah umat manusia. Ada banyak pendapat bahwa sektor kesehatan dan bioteknologi sangat diuntungkan oleh transformasi ini. Sejauh mana transformasi ini akan berdampak positif bergantung pada bagaimana kita menavigasi risiko dan peluang yang muncul di sepanjang jalan
Harnessing the power of marine terpenoids against diabetes-associated oxidative stress.
No full textDiabetes mellitus (DM), particularly type 2 diabetes (T2DM), remains a significant
global health concern, driven largely by oxidative stress-induced damage. Marine
terpenoids, bioactive compounds extracted from diverse marine organisms such
as algae, sponges, and corals, present promising antioxidant and antidiabetic
potential. This review systematically evaluates the chemical diversity, biological
sources, and mechanisms of action of marine terpenoids in mitigating diabetesassociated
oxidative stress. Marine terpenoids exhibit potent antioxidant capabilities
via radical scavenging, modulation of cellular antioxidant defenses, regulation
of redox-sensitive pathways such as Nrf2/ARE and NF-κB, metal chelation, and
pro-oxidant enzyme inhibition. Preclinical studies underscore their efficacy in
reducing hyperglycemia, enhancing insulin sensitivity, preserving pancreatic β-cell
function, and protecting against diabetic complications, including nephropathy and
cardiovascular diseases. Despite the promising preliminary results, further studies
addressing bioavailability, pharmacokinetics, long-term safety, and sustainability
are imperative to establish marine terpenoids as viable therapeutic options for
diabetes management
Partisipasi Sistem Renin-Angiotensin Dalam Progresivitas Aterosklerosis.pdf
No full textSistem
renin-angiotensin (SAR) telah diketahui membentuk jaringan endokrin yang
mempertahankan tekanan darah via perubahan-perubahan pada resisten vaskuler
perifer serta pembetulan homeostasis akut yang rancu. Sistem
ini sekarang dipercayai penting dalam pengaturan tekanan darah jangka panjang,
progresi dari nefropati diabetes, perkembangan kardiomiopati hipertensif. Penemuan-penemuan baru menunjukan bahwa SAR membentuk suatu faktor yang
dapat memodulasi perkembangan dan progresi dari aterosklerosis. Hal ini berdampak pada perubahan pengobatan
aterosklerosis diluar statin dan obat-obat pencegah penyakit kardiovaskuler
lainny
Nutritional composition and action mechanism of Channa striata meat in wound healing: A systematic review
Get PDFWound healing is a complex biological process requiring adequate nutritional support, particularly proteins, amino acids, fatty acids, and essential minerals. Snakehead fish (Channa striata) has been traditionally consumed in Southeast Asia to accelerate recovery after surgery and childbirth. Emerging evidence suggests that its nutritional composition plays a pivotal role in tissue repair. The aim of this systematic review was to consolidate evidence on the nutritional composition of C. striata and elucidate its mechanisms of action in wound healing based on preclinical and clinical studies. A systematic search was conducted across PubMed, ScienceDirect, ProQuest, and Google Scholar for studies published between 2000 and 2023, following PRISMA 2020 guidelines. Eligible studies included biochemical analyses, in vitro and in vivo preclinical studies, and clinical trials assessing the wound-healing effects of C. striata. Data extraction covered nutrient composition, study design, wound-healing parameters, and mechanistic pathways. Out of 2898 identified studies, 22 of them met the inclusion criteria: ten biochemical composition studies, nine preclinical investigations, and four clinical trials. C. striata extract demonstrated high levels of albumin (0.76–10.73 g/100 g), essential and non-essential amino acids (notably glutamic acid, arginine, and glycine), fatty acids (palmitic, arachidonic, linoleic), and minerals such as zinc and copper. Preclinical models consistently showed enhanced fibroblast proliferation, epithelialization, tensile strength, and collagen deposition. Clinical studies in post-cesarean patients reported significant improvements in wound healing scores, uterine involution, pain reduction, and biomarker modulation (VEGF, IL-6, MMP-9). In conclusion, C. striata exhibits promising wound-healing potential attributable to its rich nutrient profile and multi-pathway mechanisms involving collagen synthesis, angiogenesis, and immunomodulation. However, the limited number of clinical trials underscores the need for larger, well-designed studies to confirm its translational efficacy in human wound care
Pharmacokinetic equivalence study of nonsteroidal anti-inflammatory drug etoricoxib
No full textRaymond R Tjandrawinata,1 Arini Setiawati,2 Dwi Nofiarny,1 Liana W Susanto,1 Effi Setiawati3 1Dexa Laboratories of Biomolecular Sciences Unit, Dexa Medica Group, Cikarang, West Java, Indonesia; 2Department of Pharmacology and Therapeutics, Medical Faculty, University of Indonesia, Jakarta, Indonesia; 3Bioavailability and Bioequivalence Laboratory Unit, PT Equilab International, Jakarta, Indonesia Purpose: The current study aimed to evaluate whether a generic product of etoricoxib 120 mg film-coated tablet (the test drug) was bioequivalent to the reference product (Arcoxia® film-coated tablet 120 mg).Methods: This was a randomized, open-label, two-sequence, crossover study under fasting condition, with a 14-day washout period, involving 26 healthy adult male and female subjects. Blood samples were taken and analyzed for plasma concentrations of etoricoxib (Chemical Abstracts Service [CAS] 202409-33-4) using a high-pressure liquid chromatography–ultraviolet detector (HPLC-UV) system capable of measuring etoricoxib concentrations ranging from 5.00 to 5002.90 ng/mL, with the lowest limit of quantitation of 5.00 ng/mL. A noncompartmental method was used to determine the pharmacokinetic parameters of a single-dose administration of the drug, including the area under plasma concentration–time curve from time zero to the time of last observed concentration (AUC0-t), the area under plasma concentration–time curve from time zero to infinity (AUC0-∞), the maximum plasma concentration (Cmax), the time to reach the maximum plasma concentration (tmax), and the terminal half-life (t½).Results: After a single-dose administration of etoricoxib 120 mg film-coated tablet, the mean (SD) values for the AUC0-72h and Cmax of the test drug were 45913.42 (13142.19) ng·h/mL and 3155.93 (752.81) ng/mL, respectively; the values for the reference drug were 44577.20 (13541.85) ng⋅h/mL and 2915.13 (772.81) ng/mL, respectively. The geometric mean ratios (90% CIs) of the test drug/reference drug were 103.40% (98.70%–108.32%) for AUC0-72h and 109.26% (100.18%–119.18%) for Cmax. No clinically significant differences in tmax and t½values were found between the test drug and the reference drug. No adverse events were experienced by the subjects during this study.Conclusion: The present study demonstrated that the evaluated generic etoricoxib 120 mg film-coated tablets were bioequivalent to the reference drug. Keywords: bioavailability, bioequivalence, etoricoxib, nonsteroidal anti-inflammatory drug, selective cyclooxygenase-2 inhibitor 
Bioequivalence study of two formulations of candesartan cilexetil tablet in healthy subjects under fasting conditions
No full textRaymond R Tjandrawinata,1 Effi Setiawati,2 Danang Agung Yunaidi,2 Ronal Simanjuntak,2 Iwan Dwi Santoso,2 Liana W Susanto1 1Dexa Laboratories of Biomolecular Sciences (DLBS), Cikarang, Indonesia; 2Bioavailability and Bioequivalence Laboratory, PT Equilab International, Jakarta, Indonesia Introduction: The present study was conducted to compare the bioavailability of two candesartan cilexetil 16 mg tablet formulations (test and reference formulations). Materials and methods: This study was a randomized, single- blind, two-period, cross-over study which included 24 healthy adult male and female subjects under fasting conditions. The pharmacokinetic parameters were determined based on the concentrations of candesartan (CAS 139481-59-7), using ultra-pressure high-performance liquid chromatography with a tandem mass spectrometer detector. In each of the two study periods (separated by a washout period of 1 week), a single dose of test or reference product was administered. The pharmacokinetic parameters assessed were area under the plasma concentration time curve (AUC) from time 0 hours to 24 hours, AUC from time zero to infinity, the peak plasma concentration of the drug (Cmax), time to achieve the Cmax, and the elimination half-life. Results: The geometric mean ratios (90% confidence interval) of the test drug/reference drug for candesartan were 100.92% (92.15%–110.52%) for the AUC from 0 hours to 24 hours, 100.24% (92.24%–108.95%) for the AUC from time zero to infinity, and 106.71% (93.20%–122.18%) for the Cmax. The differences between the test and reference product in the time to achieve Cmax values and elimination half-life values were not statistically significant (P > 0.05). The 90% confidence intervals of the test/reference AUC ratio and Cmax ratio of candesartan were within the acceptance range for bioequivalence. There was no adverse event encountered during this bioequivalence study. Conclusion: It was concluded that the two candesartan tablet formulations (the test and reference product) were bioequivalent. Keywords: angiotensin-2 receptor antagonist, antihypertension, bioavailability, bioequivalence, candesartan, pharmacokinetic
- …
