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  1. Fulltext Recommendations by the Asian Pacific society of nephrology (APSN) on the appropriate use of HIF-PH inhibitors
    Yap DYH, McMahon LP, Hao CM, Hu N, Okada H, Suzuki Y, et al.
    Nephrology (Carlton), 2021 Feb;26(2):105-118.
    PMID: 33222343 DOI: 10.1111/nep.13835
    Renal anaemia is a common and important complication in patients with chronic kidney disease (CKD). The current standard-of-care treatment for renal anaemia in CKD patients involves ensuring adequate iron stores and administration of erythropoietin stimulating agents (ESA). Hypoxia inducible factor (HIF) is a key transcription factor primarily involved in the cellular regulation and efficiency of oxygen delivery. Manipulation of the HIF pathway by the use of HIF-prolyl hydroxylase inhibitors (HIF-PHI) has emerged as a novel approach for renal anaemia management. Despite it being approved for clinical use in various Asia-Pacific countries, its novelty mandates the need for nephrologists and clinicians generally in the region to well understand potential benefits and harms when prescribing this class of drug. The Asian Pacific society of nephrology HIF-PHI Recommendation Committee, formed by a panel of 11 nephrologists from the Asia-Pacific region who have clinical experience or have been investigators in HIF-PHI studies, reviewed and deliberated on the clinical and preclinical data concerning HIF-PHI. This recommendation summarizes the consensus views of the committee regarding the use of HIF-PHI, taking into account both available data and expert opinion in areas where evidence remains scarce.
    Matched MeSH terms: Pharmaceutical Preparations
  2. Functional food and nutra-pharmaceutical perspectives of date (Phoenix dactylifera L.) fruit
    Younas A, Naqvi SA, Khan MR, Shabbir MA, Jatoi MA, Anwar F, et al.
    J Food Biochem, 2020 09;44(9):e13332.
    PMID: 32588917 DOI: 10.1111/jfbc.13332
    Date palm counts among the oldest fruit crops of the world and is mainly cultivated for its highly nutritious fruits consumed as a staple food in many countries, especially in the Gulf region. Dates are enriched with numerous therapeutic bioactives and functional compounds such as phenolics, flavonols, carotenoids, minerals, and vitamins that not only provide an appreciable amount of energy required for the human body but also act as an effective therapeutic agent against several diseases. This review aimed to provide a deep insight into the nutritional as well as phytochemicals profile of date fruit and its seeds in order to explore their biological (anti-cancer, anti-diabetic, cardio-protective, anti-inflammatory properties), functional food, and nutra-pharmaceutical attributes. PRACTICAL APPLICATIONS: This review provides updated information regarding the date fruits and seeds phytochemicals composition together with highlighting dates potential as a natural therapeutic agent against several diseases. The study also urges the importance of consuming dates as a great package to live a healthy life due to the functional food and nutraceutical properties of this valuable fruit. The study also provides information first time as recommending dates to cope with the hidden hunger or micronutrient deficiency faced by the third world inhabitants. Hence, the review may further help the industry and researchers to explore the potential of dates for future medicinal and nutra-pharmaceutical applications.
    Matched MeSH terms: Pharmaceutical Preparations*
  3. Fulltext Regulatory guidelines for biosimilars in Malaysia
    Abas A
    Biologicals, 2011 Sep;39(5):339-42.
    PMID: 21784655 DOI: 10.1016/j.biologicals.2011.06.009
    The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. Thus, biosimilars are unique - they are not a true chemical generic and are regulated via a distinct regulatory framework. This report discusses the features of Malaysian regulatory oversight of biosimilars and experience acquired in the evaluation of some products from various countries. Ensuring regulatory position adequately reflects scientific advancement, expertise/resources is key. The regulatory situation is an evolving process. Various guidance documents are being prepared with the aim of developing a uniform global framework towards assuring the dual goal of lower costs and patient safety while expediting the availability of important biosimilar products.
    Matched MeSH terms: Pharmaceutical Preparations/standards*
  4. Fulltext Determination and risk assessment of pharmaceutical residues in the urban water cycle in Selangor Darul Ehsan, Malaysia
    Mohd Hanafiah Z, Wan Mohtar WHM, Abd Manan TS, Bachi NA, Abu Tahrim N, Abd Hamid HH, et al.
    PeerJ, 2023;11:e14719.
    PMID: 36748091 DOI: 10.7717/peerj.14719
    The environmental fate of non-steroidal anti-inflammatory drugs (NSAIDs) in the urban water cycle is still uncertain and their status is mainly assessed based on specific water components and information on human risk assessments. This study (a) explores the environmental fate of NSAIDs (ibuprofen, IBU; naproxen, NAP; ketoprofen, KET; diazepam, DIA; and diclofenac, DIC) in the urban water cycle, including wastewater, river, and treated water via gas chromatography-mass spectrophotometry (GCMS), (b) assesses the efficiency of reducing the targeted NSAIDs in sewage treatment plant (STP) using analysis of variance (ANOVA), and (c) evaluates the ecological risk assessment of these drugs in the urban water cycle via teratogenic index (TI) and risk quotient (RQ). The primary receptor of contaminants comes from urban areas, as a high concentration of NSAIDs is detected (ranging from 5.87 × 103 to 7.18 × 104 ng/L). The percentage of NSAIDs removal in STP ranged from 25.6% to 92.3%. The NAP and KET were still detected at trace levels in treated water, indicating the persistent presence in the water cycle. The TI values for NAP and DIA (influent and effluent) were more than 1, showing a risk of a teratogenic effect. The IBU, KET, and DIC had values of less than 1, indicating the risk of lethal embryo effects. The NAP and DIA can be classified as Human Pregnancy Category C (2.1 > TI ≥ 0.76). This work proved that these drugs exist in the current urban water cycle, which could induce adverse effects on humans and the environment (RQ in high and low-risk categories). Therefore, they should be minimized, if not eliminated, from the primary sources of the pollutant (i.e., STPs). These pollutants should be considered a priority to be monitored, given focus to, and listed in the guideline due to their persistent presence in the urban water cycle.
    Matched MeSH terms: Pharmaceutical Preparations
  5. Development and Practical Application of a Multiple-Criteria Decision Analysis Framework on Respiratory Inhalers: Is It Always Useful in the MOH Malaysia Medicines Formulary Listing Context?
    Yong YV, Mahamad Dom SH, Ahmad Sa'ad N, Lajis R, Md Yusof FA, Abdul Rahaman JA
    MDM Policy Pract, 2021 03 30;6(1):2381468321994063.
    PMID: 33855190 DOI: 10.1177/2381468321994063
    Objectives. The current health technology assessment used to evaluate respiratory inhalers is associated with limitations that have necessitated the development of an explicit formulary decision-making framework to ensure balance between the accessibility, value, and affordability of medicines. This study aimed to develop a multiple-criteria decision analysis (MCDA) framework, apply the framework to potential and currently listed respiratory inhalers in the Ministry of Health Medicines Formulary (MOHMF), and analyze the impacts of applying the outputs, from the perspective of listing and delisting medicines in the formulary. Methods. The overall methodology of the framework development adhered to the recommendations of the ISPOR MCDA Emerging Good Practices Task Force. The MCDA framework was developed using Microsoft Excel 2010 and involved all relevant stakeholders. The framework was then applied to 27 medicines, based on data gathered from the highest levels of available published evidence, pharmaceutical companies, and professional opinions. The performance scores were analyzed using the additive model. The end values were then deliberated by an expert committee. Results. A total of eight main criteria and seven subcriteria were determined by the stakeholders. The economic criterion was weighted at 30%. Among the noneconomic criteria, "patient suitability" was weighted the highest. Based on the MCDA outputs, the expert committee recommended one potential medicine (out of three; 33%) be added to the MOHMF and one existing medicine (out of 24; 4%) be removed/delisted from the MOHMF. The other existing medicines remained unchanged. Conclusions. Although this framework was useful for deciding to add new medicines to the formulary, it appears to be less functional and impactful for the removal/delisting existing medicines from the MOHMF. The generalizability of this conclusion to other formulations remains to be confirmed.
    Matched MeSH terms: Pharmaceutical Preparations
  6. Fulltext Imidazole-rich copper peptides as catalysts in xenobiotic degradation
    Begum SZ, Nizam NSM, Muhamad A, Saiman MI, Crouse KA, Abdul Rahman MB
    PLoS One, 2020;15(11):e0238147.
    PMID: 33147237 DOI: 10.1371/journal.pone.0238147
    Laccases, oxidative copper-enzymes found in fungi and bacteria were used as the basis in the design of nona- and tetrapeptides. Laccases are known to be excellent catalysts for the degradation of phenolic xenobiotic waste. However, since solvent extraction of laccases is environmentally-unfriendly and yields obtained are low, they are less preferred compared to synthetic catalysts. The histidine rich peptides were designed based on the active site of laccase extracted from Trametes versicolor through RCSB Protein Data Bank, LOMETS and PyMol software. The peptides were synthesized using Fmoc-solid phase peptide synthesis (SPPS) with 30-40% yield. These peptides were purified and characterized using LC-MS (purities >75%), FTIR and NMR spectroscopy. Synthesized copper(II)-peptides were crystallized and then analyzed spectroscopically. Their structures were elucidated using 1D and 2D NMR. Standards (o,m,p-cresol, 2,4-dichlorophenol) catalysed using laccase from Trametes versicolor (0.66 U/mg) were screened under different temperatures and stirring rate conditions. After optimizing the degradation of the standards with the best reaction conditions reported herein, medications with phenolic and aromatic structures such as ibuprofen, paracetamol (acetaminophen), salbutamol, erythromycin and insulin were screened using laccase (positive control), apo-peptides and copper-peptides. Their activities evaluated using GC-MS, were compared with those of peptide and copper-peptide catalysts. The tetrapeptide was found to have the higher degradation activity towards salbutamol (96.8%) compared with laccase at 42.8%. Ibuprofen (35.1%), salbutamol (52.9%) and erythromycin (49.7%) were reported to have the highest degradation activities using Cu-tetrapeptide as catalyst when compared with the other medications. Consequently, o-cresol (84%) was oxidized by Tp-Cu while the apo-peptides failed to oxidize the cresols. Copper(II)-peptides were observed to have higher catalytic activity compared to their parent peptides and the enzyme laccase for xenobiotic degradation.
    Matched MeSH terms: Pharmaceutical Preparations/chemistry
  7. Fulltext Development and Validation of a Questionnaire on Knowledge, Attitude, and Perception Towards Allergic Reactions of Paracetamol
    Dellemin NA, Zahari Z, Ahmad Hassali MA, Abdul Rashid S
    J Pharm Bioallied Sci, 2020 10 08;12(4):428-435.
    PMID: 33679089 DOI: 10.4103/jpbs.JPBS_247_19
    Introduction: National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia has received 1018 adverse drug reaction reports related to paracetamol with 1972 adverse events from the year 2000 to February 2015. Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis, and acute generalized exanthematous pustulosis may develop as a result of allergic reactions of paracetamol. This study aimed to develop and validate a questionnaire regarding Knowledge, Attitude, and Perception towards Allergic Reactions of Paracetamol (KAP-ARP) among the general population.

    Materials and Methods: Content and face validity of the KAP-ARP were determined by four experts and 20 respondents, respectively. A questionnaire with 36 items, consisting of 16 Knowledge, 9 Attitude, and 11 Perception items, was distributed to 177 respondents. Exploratory factor analysis (EFA) was performed for construct validity. Cronbach's alpha was used to determine the reliability of the questionnaire.

    Results: EFA constructed 13 Knowledge, 8 Attitude, and 8 Perception items. The final KAP-ARP questionnaire is reliable based on its internal consistency reliability (Knowledge: α = 0.78; Attitude: α = 0.63; Perception: α = 0.70).

    Conclusion: A valid and reliable questionnaire that is useful for measuring KAP-ARP among the general population has been developed.

    Matched MeSH terms: Pharmaceutical Preparations
  8. The effect of thyroxine on the renal function of asphyxiated neonates
    Rostenberghe, H.V., Haider, D., Abdullah, Y., Amir, H., Abdul Razak, A.R.
    Malaysian Journal of Paediatrics and Child Health, 1998;10(2):19-23.
    MyJurnal
    Thyroxine has been shown to have a beneficial effect on renal function in cases of impending renal failure in ani-mal studies.'5 Studies of the use of thyroxine in humans in impending renal failure are scarce. The aim of this study was to assess the effect of oral thyroxine on the renal function of asphyxiated term neonates who often have renal impairment.
    A randomised control trial was conducted, involving 30 term asphyxiated neonates. The study group (n=15) was given thyroxine (50 pg) orally on days 1, 2 and 3 of life and placebo was given to the control group (n=15). Renal function was studied on day 1 and day 4 of life. The two groups did not differ significantly as regards gestational age, birth weight, severity of asphyxia, preg-nancy or delivery complications, fluids administered and drugs used. There was no significant difference in urine output, creatinine clearance and fractional excretion of sodium on day 1 but there was a trend towards a worse renal function on day 1 in the treatment group. The creatinine clearance was significantly better in the treat-ment group on day 4 (p = 0.017). Urine output and fractional excretion of sodium on day 4 were better in the treatment group but the differences did not reach statistical significance (p = 0.14 and 0.057 respectively). Statistical analysis on the differences between day 4 and day 1 showed statistical significance only for creatinine clearance: creatinine clearance day 4 minus creatinine clearance day 1 was 52.6 (±32.4) for the thyroxine group and 7.3 (±7.8) for the controls (p= 0.006).
    These data support the hypothesis that thyroxine may have a significant beneficial effect on the renal function in term neonates with perinatal asphyxia. Thyroxine may be proven useful in future for patients with impending renal failure.
    Matched MeSH terms: Pharmaceutical Preparations
  9. Fulltext Potential of Anti-Cancer Activity of Secondary Metabolic Products from Marine Fungi
    Noman E, Al-Shaibani MM, Bakhrebah MA, Almoheer R, Al-Sahari M, Al-Gheethi A, et al.
    J Fungi (Basel), 2021 May 30;7(6).
    PMID: 34070936 DOI: 10.3390/jof7060436
    The promising feature of the fungi from the marine environment as a source for anticancer agents belongs to the fungal ability to produce several compounds and enzymes which contribute effectively against the cancer cells growth. L-asparaginase acts by degrading the asparagine which is the main substance of cancer cells. Moreover, the compounds produced during the secondary metabolic process acts by changing the cell morphology and DNA fragmentation leading to apoptosis of the cancer cells. The current review has analyed the available information on the anticancer activity of the fungi based on the data extracted from the Scopus database. The systematic and bibliometric analysis revealed many of the properties available for the fungi to be the best candidate as a source of anticancer drugs. Doxorubicin, actinomycin, and flavonoids are among the primary chemical drug used for cancer treatment. In comparison, the most anticancer compounds producing fungi are Aspergillusniger, A.fumigatusA.oryzae, A.flavus, A. versicolor, A.terreus,Penicilliumcitrinum, P.chrysogenum, and P.polonicum and have been used for investigating the anticancer activity against the uterine cervix, pancreatic cancer, ovary, breast, colon, and colorectal cancer.
    Matched MeSH terms: Pharmaceutical Preparations
  10. Chemopreventive Effect of Phaleria macrocarpa on Colorectal Cancer Aberrant Crypt Foci In vivo
    Shwter AN, Abdullah NA, Alshawsh MA, El-Seedi HR, Al-Henhena NA, Khalifa SA, et al.
    J Ethnopharmacol, 2016 Aug 1.
    PMID: 27492327 DOI: 10.1016/j.jep.2016.08.002
    Natural products are important ingredients for pharmaceutical applications specifically new entities for treating cancer and other diseases. Phaleria macrocarpa is native of Indonesia and considered as a prolific source of bioactive substances useful for chemoprevention.
    Matched MeSH terms: Pharmaceutical Preparations
  11. Separation of selected imidazole enantiomers using dual cyclodextrin system in micellar electrokinetic chromatography
    Wan Ibrahim WA, Abd Wahib SM, Hermawan D, Sanagi MM, Aboul-Enein HY
    Chirality, 2013 Jun;25(6):328-35.
    PMID: 23716264 DOI: 10.1002/chir.22156
    Cyclodextrin-modified micellar electrokinetic chromatography (CD-MEKC) method was developed for simultaneous enantioseparation of three imidazole drugs namely tioconazole, isoconazole and fenticonazole. Three easily available and inexpensive cyclodextrins namely 2-hydroxypropyl-β-cyclodextrin (HP-β-CD), 2-hydroxypropyl-γ-cyclodextrin (HP-γ-CD) and heptakis(2,6-di-O-methyl)-β-cyclodextrin (DM-β-CD) were evaluated to discriminate the six stereoisomers of the drugs. However, none of the three CDs gave a complete enantioseparation of the drugs. Effective enantioseparation of tioconazole, isoconazole and fenticonazole was achieved using a combination of 35 mM HP-γ-CD and 10 mM DM-β-CD as chiral selectors. The best separation using both HP-γ-CD and DM-β-CD (35 mM:10 mM) as chiral selectors were accomplished in background electrolyte (BGE) containing 35 mM phosphate buffer (pH 7.0), 50 mM sodium dodecyl sulfate (SDS) and 15% (v/v) acetonitrile at 27 kV and 30 °C with all peaks resolved in less than 15 min with resolutions, Rs 1.90-27.22 and peak efficiencies, N > 180 000. The developed method was linear over the concentration range of 25-200 mg l(-1) (r(2) > 0.998) and the detection limits (S/N = 3) of the three imidazole drugs were found to be 2.7-7.7 mg l(-1). The CD-MEKC method was successfully applied to the determination of the three imidazole drugs in spiked human urine sample and commercial cream formulation of tioconazole and isoconazole with good recovery (93.6-106.2%) and good RSDs ranging from 2.30-6.8%.
    Matched MeSH terms: Pharmaceutical Preparations/urine
  12. Stability-indicating micellar electrokinetic chromatography method for the analysis of sumatriptan succinate in pharmaceutical formulations
    Al Azzam KM, Saad B, Tat CY, Mat I, Aboul-Enein HY
    J Pharm Biomed Anal, 2011 Dec 15;56(5):937-43.
    PMID: 21873014 DOI: 10.1016/j.jpba.2011.08.007
    A micellar electrokinetic chromatography method for the determination of sumatriptan succinate in pharmaceutical formulations was developed. The effects of several factors such as pH, surfactant and buffer concentration, applied voltage, capillary temperature, and injection time were investigated. Separation took about 5 min using phenobarbital as internal standard. The separation was carried out in reversed polarity mode at 20 °C, 26 kV and using hydrodynamic injection for 10s. Separation was achieved using a bare fused-silica capillary 50 μm×40 cm and background electrolyte of 25 mM sodium dihydrogen phosphate-adjusted with concentrated phosphoric acid to pH 2.2, containing 125 mM sodium dodecyl sulfate and detection was at 226 nm. The method was validated with respect to linearity, limits of detection and quantification, accuracy, precision and selectivity. The calibration curve was linear over the range of 100-2000 μg mL(-1). The relative standard deviations of intra-day and inter-day precision for migration time, peak area, corrected peak area, ratio of corrected peak area and ratio of peak area were less than 0.68, 3.48, 3.28, 2.97 and 2.83% and 2.01, 5.50, 4.46, 4.92 and 4.07%, respectively. The proposed method was successfully applied to the determinations of the analyte in tablet. Forced degradation studies were conducted by introducing a sample of sumatriptan succinate standard solution to different forced degradation conditions using neutral (water), basic (0.1 M NaOH), acidic (0.1 M HCl), oxidative (10% H(2)O(2)) and photolytic (exposure to UV light at 254 nm for 2 h). It is concluded that the stability-indicating method for sumatriptan succinate can be used for the analysis of the drug in various samples.
    Matched MeSH terms: Pharmaceutical Preparations/chemistry*
  13. Simultaneous determination of ofloxacin and ornidazole in pharmaceutical preparations by capillary zone electrophoresis
    See KL, Elbashir AA, Saad B, Ali AS, Aboul-Enein HY
    Biomed Chromatogr, 2009 Dec;23(12):1283-90.
    PMID: 19488980 DOI: 10.1002/bmc.1251
    A simple, rapid and validated capillary electrophoretic method has been developed for the separation and determination of ofloxacin and ornidazole in pharmaceutical formulations with detection at 230 nm. Optimal conditions for the quantitative separations were investigated. Analysis times shorter than 4 min were obtained using a background electrolyte solution consisting of 25 mmol/L phosphoric acid adjusted with 1 M Tris buffer to pH 8.5, with hydrodynamic injection of 5 s and 20 kV separation voltage. The validation criteria for accuracy, precision, linearity and limits of detection and quantitation were examined and discussed. An excellent linearity was obtained in concentration range 25-250 microg/mL. The detection limits for ofloxacin and ornidazole were 1.03 +/- 0.11 and 1.80 +/- 0.06 microg/mL, respectively. The proposed method has been applied for the analysis of ofloxacin and ornidazole both individually and in a combined dosage tablet formulation. The proposed validated method showed recoveries between 96.16 and 105.23% of the nominal contents.
    Matched MeSH terms: Pharmaceutical Preparations/chemistry*
  14. Simultaneous determination of atenolol and amiloride in pharmaceutical preparations by capillary zone electrophoresis with capacitively coupled contactless conductivity detection
    Al Azzam KM, Saad B, Aboul-Enein HY
    Biomed Chromatogr, 2010 Sep;24(9):948-53.
    PMID: 20082285 DOI: 10.1002/bmc.1390
    Capillary zone electrophoresis coupled with a capacitively coupled contactless conductivity detector (CE-C(4)D) has been employed for the determination of atenolol and amiloride in pharmaceutical formulations. Acetic acid (150 mm) was used as background electrolyte. The influence of several factors (detector excitation voltage and frequency, buffer concentration, applied voltage, capillary temperature and injection time) was studied. Non-UV-absorbing L-valine was used as internal standard; the analytes were all separated in less than 7 min. The separation was carried out in normal polarity mode at 28 degrees C, 25 kV and using hydrodynamic injection (25 s). The separation was effected in an uncoated fused-silica capillary (75 microm, i.d. x 52 cm). The CE-C(4)D method was validated with respect to linearity, limit of detection and quantification, accuracy, precision and selectivity. Calibration curves were linear over the range 5-250 microg/mL for the studied analytes. The relative standard deviations of intra- and inter-day migration times and corrected peak areas were less than 6.0%. The method showed good precision and accuracy and was successfully applied to the simultaneous determination of atenolol and amiloride in different pharmaceutical tablet formulations.
    Matched MeSH terms: Pharmaceutical Preparations/analysis*
  15. Simultaneous determination of atenolol, chlorthalidone and amiloride in pharmaceutical preparations by capillary zone electrophoresis with ultraviolet detection
    Al Azzam KM, Saad B, Aboul-Enein HY
    Biomed Chromatogr, 2010 Sep;24(9):977-81.
    PMID: 20066730 DOI: 10.1002/bmc.1395
    Capillary zone electrophoresis methods for the simultaneous determination of the beta-blocker drugs, atenolol, chlorthalidone and amiloride, in pharmaceutical formulations have been developed. The influences of several factors (buffer pH, concentration, applied voltage, capillary temperature and injection time) were studied. Using phenobarbital as internal standard, the analytes were all separated in less than 4 min. The separation was carried out in normal polarity mode at 25 degrees C, 25 kV and using hydrodynamic injection (10 s). The separation was effected in an uncoated fused-silica capillary (75 mum i.d. x 52 cm) and a background electrolyte of 25 mm H(3)PO(4) adjusted with 1 m NaOH solution (pH 9.0) and detection at 198 nm. The method was validated with respect to linearity, limit of detection and quantification, accuracy, precision and selectivity. Calibration curves were linear over the range 1-250 microg/mL for atenolol and chlorthalidone and from 2.5-250 microg/mL for amiloride. The relative standard deviations of intra- and inter-day migration times and corrected peak areas were less than 6.0%. The method showed good precision and accuracy and was successfully applied to the simultaneous determination of atenolol, chlorthalidone and amiloride in various pharmaceutical tablets formulations.
    Matched MeSH terms: Pharmaceutical Preparations/analysis*
  16. Determination of aminoglutethimide enantiomers in pharmaceutical formulations by capillary electrophoresis using methylated-beta-cyclodextrin as a chiral selector and computational calculation for their respective inclusion complexes
    Elbashir AA, Suliman FE, Saad B, Aboul-Enein HY
    Talanta, 2009 Feb 15;77(4):1388-93.
    PMID: 19084654 DOI: 10.1016/j.talanta.2008.09.029
    A capillary electrophoretic method for the separation of the aminoglutethimide (AGT) enantiomers using methylated-beta-cyclodextrin (M-beta-CD) as chiral selector is described. Several parameters affecting the separation were studied, including the type and concentration of chiral selector, buffer pH, voltage and temperature. Good chiral separation of the racemic mixture was achieved in less than 9 min with resolution factor Rs=2.1, using a fused-silica capillary and a background electrolyte (BGE) of tris-phosphate buffer solution (50 mmol L(-1), pH 3.0) containing 30 mgm L(-1) of M-beta-CD. The separation was carried out in normal polarity mode at 25 degrees C, 16 kV and using hydrostatic injection. Acceptable validation criteria for selectivity, linearity, precision, and accuracy/recovery were included. The proposed method was successfully applied to the assay of AGT enantiomers in pharmaceutical formulations. The computational calculations for the inclusion complexes of the R- and S-AGT-M-beta-CD rationalized the reasons for the different migration times between the AGT enantiomers.
    Matched MeSH terms: Pharmaceutical Preparations/analysis*
  17. A review: Gelatine as a bioadhesive material for medical and pharmaceutical applications
    Ahmady A, Abu Samah NH
    Int J Pharm, 2021 Oct 25;608:121037.
    PMID: 34438009 DOI: 10.1016/j.ijpharm.2021.121037
    Bioadhesive polymers offer versatility to medical and pharmaceutical inventions. The incorporation of such materials to conventional dosage forms or medical devices may confer or improve the adhesivity of the bioadhesive systems, subsequently prolonging their residence time at the site of absorption or action and providing sustained release of actives with improved bioavailability and therapeutic outcomes. For decades, much focus has been put on scientific works to replace synthetic polymers with biopolymers with desirable functional properties. Gelatine has been considered one of the most promising biopolymers. Despite its biodegradability, biocompatibility and unique biological properties, gelatine exhibits poor mechanical and adhesive properties, limiting its end-use applications. The chemical modification and blending of gelatine with other biomaterials are strategies proposed to improve its bioadhesivity. Here we discuss the classical approaches involving a variety of polymer blends and composite systems containing gelatine, and gelatine modifications via thiolation, methacrylation, catechol conjugation, amination and other newly devised strategies. We highlight several of the latest studies on these strategies and their relevant findings.
    Matched MeSH terms: Pharmaceutical Preparations*
  18. Fulltext The Therapeutic Effect and In Vivo Assessment of Palmitoyl-GDPH on the Wound Healing Process
    Fadilah NIM, Rahman MBA, Yusof LM, Mustapha NM, Ahmad H
    Pharmaceutics, 2021 Feb 01;13(2).
    PMID: 33535623 DOI: 10.3390/pharmaceutics13020193
    The standard treatment of open wounds via the direct usage of therapeutic agents is not without limitations with respect to healing. Small peptides can create a favorable milieu for accelerating the healing of wounds. This study presents the potential of a novel fatty acid conjugated tetrapeptide (palmitic acid-glycine-aspartic acid-proline-histidine; Palmitoyl-GDPH) in alleviating wound healing. Tetracycline was employed as a standard control drug following its significance in wound healing including biologically active and antimicrobial effects. The peptide in liquid form was applied on to a 4 cm2 full thickness wound surgically induced at the dorsum of Sprague Dawley (SD) rats. The in vivo wound treatment with Palmitoyl-GDPH for eighteen days, histologically demonstrated an almost perfect healing exhibited by increased re-epithelialization, enhanced collagen deposition, and diminished scar formation compared to the controls. In addition, the well-developed epidermal-dermal junction and ultimate stimulation of hair follicle-growth in the Palmitoyl-GDPH treated group indicated the wound to have healed as functionally viable tissues. In general, the much lower hemogram values in the Palmitoyl-GDPH group indicated that the ongoing healing is en route to an earlier recovery. Additionally, the liver, kidney, and pancreas function biomarkers being within normal limits indicated the relatively non-toxic nature of Palmitoyl-GDPH at the used dosage. These results indisputably supported the great potential of this newly synthesized Palmitoyl-GDPH to be used as an effective therapeutic agent for wound healing (this actually means creating a new wound).
    Matched MeSH terms: Pharmaceutical Preparations
  19. Regulatory Oversight of Cell and Gene Therapy Products in Malaysia
    Loh EYX, Ab Ghani A, Ahmad R
    Adv Exp Med Biol, 2023;1430:181-195.
    PMID: 37526848 DOI: 10.1007/978-3-031-34567-8_10
    The National Pharmaceutical Regulatory Agency (NPRA) is the agency responsible for the registration of pharmaceutical, natural, and health supplement products and notification of cosmetic products that are marketed in Malaysia. The implementation of regulatory oversight of the different types of product was in a progressive manner, with the latest addition to be regulated being the cell and gene therapy products (CGTPs), beginning January 1, 2021. CGTP can be classified as low risk (that does not require registration) or high risk (that needs to be registered). Generally, the regulation of high-risk CGTP is similar to other biological products. This chapter describes the chronology of the CGTP framework, classification of CGTP, how CGTPs fit into the current registration pathways and registration procedure, dossier requirements, and what is the current status and future direction of CGTP in Malaysia.
    Matched MeSH terms: Pharmaceutical Preparations
  20. Fulltext Gold Nanoparticles Conjugation Enhances Antiacanthamoebic Properties of Nystatin, Fluconazole and Amphotericin B
    Anwar A, Siddiqui R, Raza Shah M, Ahmed Khan N
    J Microbiol Biotechnol, 2019 Jan 28;29(1):171-177.
    PMID: 30415525 DOI: 10.4014/jmb.1805.05028
    Parasitic infections have remained a significant burden on human and animal health. In part, this is due to lack of clinically-approved, novel antimicrobials and a lack of interest by the pharmaceutical industry. An alternative approach is to modify existing clinically-approved drugs for efficient delivery formulations to ensure minimum inhibitory concentration is achieved at the target site. Nanotechnology offers the potential to enhance the therapeutic efficacy of drugs through modification of nanoparticles with ligands. Amphotericin B, nystatin, and fluconazole are clinically available drugs in the treatment of amoebal and fungal infections. These drugs were conjugated with gold nanoparticles. To characterize these gold-conjugated drug, atomic force microscopy, ultraviolet-visible spectrophotometry and Fourier transform infrared spectroscopy were performed. These drugs and their gold nanoconjugates were examined for antimicrobial activity against the protist pathogen, Acanthamoeba castellanii of the T4 genotype. Moreover, host cell cytotoxicity assays were accomplished. Cytotoxicity of these drugs and drug-conjugated gold nanoparticles was also determined by lactate dehydrogenase assay. Gold nanoparticles conjugation resulted in enhanced bioactivity of all three drugs with amphotericin B producing the most significant effects against Acanthamoeba castellanii (p ＜ 0.05). In contrast, bare gold nanoparticles did not exhibit antimicrobial potency. Furthermore, amoebae treated with drugs-conjugated gold nanoparticles showed reduced cytotoxicity against HeLa cells. In this report, we demonstrated the use of nanotechnology to modify existing clinically-approved drugs and enhance their efficacy against pathogenic amoebae. Given the lack of development of novel drugs, this is a viable approach in the treatment of neglected diseases.
    Matched MeSH terms: Pharmaceutical Preparations
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