ARCHIVE (Nr.6 2006)


FARMACIA Nr. 6 (2006):

  1. The pharmacokinetics of some oral antidiabetics - A pharmaceutical approach.
    MARIA CRISTINA RANETTI, A. RANETTI
    Abstract


  2. Formulation of some chewable tablets with vitamins by using experimental design.
    I. TOMUTA, S.E. LEUCUTA.
    Abstract


  3. The cicatrizing action of some new gemmotherapy products.
    MIHELE DENISA, MANEA STEFAN, RAICIU DANIELA, UDEANU DENISA.
    Abstract


  4. Formulation and evaluation of bioadhesive buccal tablets based on polyethylene oxide.
    ELENA DINTE, R.I. IOVANOV, S.E. LEUCUTA, DANIELA IONESCU.
    Abstract


  5. Influence of formulating variables on the properties of rapid release tablets with analgesic substances.
    ELIZA GAFITANU, GRATIELA POPA, D. CHIRVASA, I. STOLERU.
    Abstract


  6. Applications of capillary electrophoresis for the separation of some benzodiazepine derivates.
    G. HANCU, A. GÁSPÁR, Á. GYÉRESI.
    Abstract


  7. Clinical study on pregnant women with thrombophilia, regarding the monitorization of the treatment with tinzaparin sodium using the anti-FXa activity.
    GABRIELA BARBULEANU BISCHOFBERGER, VALENTINA USCATESCU, DANIELA OSTROVEANU, NICULINA MITREA, ANDREEA LETITIA NITULESCU-ARSENE.
    Abstract


  8. Heavy metals investigation from some food products using atomic absorption spectrometry.
    MAGDALENA MITITELU, DENISA MIHELE, DANIELA CRIVEANU.
    Abstract


  9. Synthesis and spectroscopic studies of copper (II) complexes with 2-hydrazino-4-R thiazole.
    LUMINITA OPREAN, O. CRISAN, ADRIANA COMSA, ANDREEA BOTA, C. SOMESAN, L. DAVID, MIOARA COMAN.
    Abstract


  10. The effects of experimental intoxication with aflatoxins, in laboratory animals.
    V. ORDEANU, A.A. ANDRIES, R. ALEXANDRESCU, A. POSTOACA, M. NECSULESCU, CARMEN ANDRIES.
    Abstract


  11. Metformin determination in human plasma.
    SILVIA IMRE, C.E. VARI, MARIA DOGARU, A. CURTICAPEAN, L. KELEMEN, DANIELA MUNTEAN.
    Abstract


  12. Experimental research on mice regarding the analgesic effect of melatonin.
    ANDREEA LETITIA NITULESCU-ARSENE, NICULINA MITREA, AURELIA CRISTEA, CRISTINA MANUELA DRAGOI.
    Abstract


  13. Promoting international relationships in the State Institute for Drug Control and Pharmaceutical Research - Bucharest, Romania (1970 - 1979).
    MARIA - GABRIELA SULIMAN, OLIMPIA SANDA.
    Abstract


  14. Thoughts of friendship and consideration came off the correspondence between professor Martian Cotrau and Graziella Baicu.
    GRAZIELLA BAICU.



ABSTRACTS:

1. THE PHARMACOKINETICS OF SOME ORAL ANTIDIABETICS - A PHARMACEUTICAL APPROACH.
MARIA CRISTINA RANETTI1, A.RANETTI.2

1Army Center for Medical Research, Bucharest, cranetti@yahoo.com;
2Central Clinical Military Hospital, Bucharest.


- Abstract -

The purpose of this article is to review the main pharmacokinetic aspects of some of the most used antidiabetics all over the world: metformin, glibenclamide, glipizide, gliclazide. We will emphasize those aspects that may be for the interest of the clinical pharmacists and physicians, in the patient's benefits. The choice of oral antidiabetics for our article is due to the fact that type 2 diabetes mellitus is one of the most spread diseases in the world, affecting almost 5% of people from all over the world and having a great impact on the quality of their life.
- pharmacokinetics
- oral antidiabetics
- clinical pharmacist.
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2. FORMULATION OF SOME CHEWABLE TABLETS WITH VITAMINS BY USING EXPERIMENTAL DESIGN.
I. TOMUTA*, S.E. LEUCUTA.

Dep. of Pharmaceutical Technology and Biopharmaceutic, Faculty of Pharmacy, "Iuliu Hatieganu" University 400023, Cluj-Napoca, ROMANIA;
*corresponding author: tomutaioan@umfcluj.ro


- Abstract -

The aim of this experimental work was the formulation of some chewable tablets with vitamins using a statistical method. In order to perform this study a fractional experimental design 26-2, with six factors and two levels was used. The formulation factors were the type of direct compression (DC) excipient used as filler, the synthetic sweetening agent ratio, the flavouring agent ratio, the microcrystalline cellulose ratio, Ludipress ratio and the lubricant ratio.
The obtained results have shown that: the type of the direct compression excipient used as filler (mannitol or sorbitol) has no influence on the taste of tablets obtained via direct compression; the aspartame ratio and the flavouring agent ratio had no influence on the flow properties of the powders blend nor for the pharmacotechnical properties of the tablets, but had a great influence on the taste; the effect of the flavour is more intense at the first contact; it is recommended not the use microcrystalline cellulose for the chewable tablets preparation; the lubricant (magnesium stearate) is recommended to be used in percentage of 0.5-0.6%.
- chewable tablets
- optimization
- experimental design
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3. THE CICATRIZING ACTION OF SOME NEW GEMMOTHERAPY PRODUCTS.
DENISA1 MIHELE, ST. MANEA2, DANIELA RAICIU2, DENISA UDEANU1.

1University of Medicine and Pharmacy "Carol Davila", Faculty of Pharmacy, Department of Clinical Laboratory and Food Safety, Traian Vuia 6, Sect. 2, Bucharest.
Email: denisamihele@yahoo.com
2Hofigal, Intrarea serelor 2A, Sect. 4, Bucharest.


- Abstract -

The study copes with the cicatrizing action of two new topical gels based on gemmoderivatives products. The action of new topical products was determined by assessing he tissue repairing after inducing experimental wounds (burns) in rats. The wounds' evolution was assessed in the following way: the treated burn areas for a group treated with the described gels have been monitored in comparison with the wounds' evolution in two other groups of rats: a control group (no treatment) and a second group cured with a natural pharmaceutical product (Cicatrizin). Both new products favored the healing of the induced burn wounds. The complete healing occurred after 9 days of treatment. In comparison, the burn wounds of rats from the control group healed after 15 days. The gemmotherapy products' effect was close to the one induced by Cicatrizin®, a pharmaceutical product already on the market.
- gemmotherapy
- cicatrizing action
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4. FORMULATION AND EVALUATION OF BIOADHESIVE BUCCAL TABLETS BASED ON POLYETHYLENE OXIDE.
ELENA DINTE1, R.I. IOVANOV1, S.E. LEUCUTA1, DANIELA IONESCU2.

University of Medicine and Pharmacy "Iuliu Hatieganu" Cluj-Napoca, 13, Emil Isac Str., Cluj-Napoca, Romania;
1Department of Pharmaceutical Technology and Biopharmaceutics;
2Department of Anaesthesia and Intensive Care.


- Abstract -

Buccal tablets with metronidazole were prepared using bioadhesive polymers: polyethylene oxide (PEO), alone and associated in a ratio of 2:1 with polyacrylic acid (Carbopol 940), sodium carboxymethylcellulose (NaCMC) and hydroxypropyl methylcellulose (Methocel K100M). The in vitro adhesion capacity was assessed by the determination of the force required for the detachment of the tablets from a synthetic membrane. The in vitro release of metronidazole was studied using a buffer solution with pH 6.8 as a dissolution medium. The quantitative determination of metronidazole was made using UV spectrophotometry at 321 nm.
The association of the three hydrophil polymers with polyethylene oxide determined a rise of the adhesiveness which was the highest in the formulation containing the PEO/Carbopol 940 association. Sodium carboxymethylcellulose determined the rise of the release rate of metronidazole and the associaton of Carbopol 940 and hydroxypropyl methylcellulose with polyethylene oxide lowered the in vitro release rate. Metronidazole released from the studied tablets followed a non-Fickian mechanism.
- polyethylene oxide
- poliacrylic acid
- sodium carboxymethylcellulose
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5. ON THE PROPERTIES OF RAPID RELEASE TABLETS WITH ANALGESIC SUBSTANCES.
ELIZA GAFITANU1, GRATIELA POPA1, D. CHIRVASA2, I. STOLERU3.

1Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, University of Medicine and Pharmacy "Gr. T. Popa" Iasi;
2"Antibiotice" Pharmaceutical Company, Iasi;
3Faculty of Mathematics, University "Al. I. Cuza" Iasi.


- Abstract -

The present study aimed at formulating and preparing rapid release tablets with a ternary analgesic combination: acetaminophen/propyphenazone/codeine phosphate (16/10/1). The influence of two formulating variables (proportion of superdisintegrant, proportion of binder) on the characteristics of tablets prepared was investigated by statistical analysis. The response variables studied were hardness and disintegration time of tablets. By regression analysis and response surface plots a direct correlation between the proportion of binder and the two response variables was observed. An optimal formula was found, containing 4 % Explotab and 2 % PVP.
- propyphenazone
- rapid release tablets
- ternary analgesic combination
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6. APPLICATIONS OF CAPILLARY ELECTROPHORESIS FOR THE SEPARATION OF SOME BENZODIAZEPINE DERIVATES.
G. HANCU1, A. GÁSPÁR2, Á. GYÉRESI1.

1University of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Chemistry, Gh Marinescu str. 38, 540139 Targu Mures, Romania; e-mail: g_hancu@rdslink.ro ;
2University of Debrecen, Department of Inorganic and Analytical Chemistry, Debrecen, Hungary.


- Abstract -

The aim of this work is to elaborate capillary electrophoresis methods, for the separation of some 1,4-benzodiazepine derivates. These are hydrophobic compounds, so the most efficient method proved to be micellar electrokinetic capillary chromatography (MECC). For the separation we used a sodium tetraborate buffer with tensioactive agent (sodium dodecyl sulphate - SDS) and different quantities of organic modifiers (methanol) or ß-cyclodextrin (ß-CD). We also optimized the analytical conditions, and studied the effect of the tetraborate, SDS, methanol or CD concentrations on the determination efficiency.
- 1,4-benzodiazepine derivates
- separation
- micellar electrokinetic capillary chromatography
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7. CLINICAL STUDY ON PREGNANT WOMEN WITH THROMBOPHILIA, REGARDING THE MONITORIZATION OF THE TREATMENT WITH TINZAPARIN SODIUM USING THE ANTI-FXa ACTIVITY.
GABRIELA BARBULEANU BISCHOFBERGER1, VALENTINA USCATESCU2, DANIELA OSTROVEANU1, NICULINA MITREA3, ANDREEA LETITIA NITULESCU-ARSENE3.

1Pfizer Romania - Department of Clinical Research, Spl. Independenţei nr.179, Bucharest;
2Fundeni Clinical Institute - Department of Haematology and Bone Marrow Transplantation "Stefan Berceanu";
3University of Medicine and Pharmacy "Carol Davila" Bucharest - Faculty of Pharmacy, Department of Biochemistry.


- Abstract -

Thrombosis and thromboembolism are morbidity and mortality causes during pregnancy and puerpering, altering the balance between procoagulant and anticoagulant factors during pregnancy, predisposes organism to venous thromboembolism.
Tinzaparin sodium (INNOHEP) is a low molecular weight heparine (LMWH) with numerous advantages compared with the oral anticoagulants and low-doses of aspirin. In the present study we monitorized the pharmacodynamic profile and efficacy of tinzaparin during pregnancy using the anti-factor Xa (anti-FXa) activity. Thirty pregnant women - 8 for treatment of thrombosis and 22 for thromboprophylaxis - received tinzaparin by once daily injection. It is considered that a dose is echilibrated and stable if after 2 succesive determination after 4 hours post-dose the level of anti-Xa is in range, the tests being made in the 4 weeks of gestation.
During the pregnancy until delivery, the dose of tinzaparine is ajusted, inorder to be maintained at a concentration of 0.1-1,0 UI/ml, by tests every 2 weeks (4 h post-dose).
The treatment and the prophilaxy with tinzaparine were interrupted during the pregnancy and restarted postpartum another 6 weeks.
- tinzaparin sodium
- anti-FXa activity
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8. HEAVY METALS INVESTIGATION FROM SOME FOOD PRODUCTS USING ATOMIC ABSORPTION SPECTROMETRY.
MAGDALENA MITITELU, DENISA MIHELE, DANIELA CRIVEANU.

University of Medicine and Pharmacy "Carol Davila", Faculty of Pharmacy, Bucharest, 6 Traian Vuia Street Department of Clinical Laboratory

- Abstract -

The presence in high amount of organic pollutants and heavy metals in environment represents a potential danger for human health and for environment too. This work presents aspects regarding the pollution with heavy metals (cadmium, lead, copper and zinc) of some food products: cow milk, cow cheese and cow meat. The samples analyzed were collected from some micro-farms from Ovidiu (near Constanţa). The heavy metals were analyzed using atomic absorption spectrometry.
- heavy metals
- atomic absorption spectrometry
- food products
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9. SYNTHESIS AND SPECTROSCOPIC STUDIES OF COPPER (II) COMPLEXES WITH 2-HYDRAZINO-4-R THIAZOLE.
LUMINITA OPREAN1, O. CRISAN1, ADRIANA COMSA1, ANDREEA BOTA1, C. SOMESAN2, L. DAVID2, MIOARA COMAN1.

1"Iuliu Hatieganu" University of Medecine and Pharmacy, Faculty of Pharmacy, 13 Emil Isac, 400023, Cluj-Napoca, Romania;
2"Babes-Bolyai" University, Faculty of Physics, 1 Mihail Kogalniceanu, 400084, Cluj-Napoca, Romania.


- Abstract -

Two new copper (II) complexes [CuL1Cl2] (C1) and [CuL2Cl2] (C2) with 2-N-acetyl-hydrazino-4-chlormethyl thiazole (L1) and 2-N-acetyl-hydrazino-4-thiazolyl acetic ester (L2) have been synthesized and characterized by means of their spectral (electronic, IR, ESR) and magnetic measurements. The shifting of the νas(NH2) and νs(NH2) of the hydrazine moiety in the IR spectra of complexes in comparison with those of the ligands suggests the participation of hydrazine nitrogen atom as bonding site in the complexes. The co-ordination of the Cu (II) ion through the Nthiazole atom is suggested by the changes of vibrations bands for the thiazole ring and the ν(CN)thiazole. The electronic diffuse reflectance (RD) and near IR (NIR) spectra are typically for Cu (II) ions with a distorted tetrahedral geometry around the metallic ions. The polycrystalline powder EPR spectra recorded at room temperature of the complexes confirm the local symmetry around the Cu (II) ion. The magnetic susceptibility measurements indicate a Curie - Weiss behavior with the magnetic moments specific for monomeric pseudotetrahedral species.
- copper (II) complexes
- 2-hydrazino-4-R thiazole
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10. THE EFFECTS OF EXPERIMENTAL INTOXICATION WITH AFLATOXINS, IN LABORATORY ANIMALS.
V. ORDEANU1, A.A. ANDRIES1, R. ALEXANDRESCU1, A. POSTOACA1, M. NECSULESCU1, CARMEN ANDRIES2.

1Army Center for Medical Research, Bucharest;
2University of Medicine and Pharmacy "Carol Davila", Faculty of Pharmacy, 6 Traian Vuia Street, Bucharest


- Abstract -

The effects of the intoxication with aflatoxins were experimentally determined, by oral administration to mice. In our study we compared the essential aspects of the mycotoxins related to human pathology. Also we tried to estimate the protective role of a medicine usually administered as an antidote, namely vitamin A.
- mycotoxins
- aflatoxicoses
- antidote
- pharmacoprotection
- treatment with vitamin A
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11. METFORMIN DETERMINATION IN HUMAN PLASMA.
SILVIA IMRE*1, C.E. VARI1, MARIA DOGARU1, A. CURTICAPEAN1, L. KELEMEN2, DANIELA MUNTEAN1.

1Faculty of Pharmacy, University of Medicine and Pharmacy, Gh. Marinescu street, 38, Tg. Mures 540139, Romania;
2Gedeon Richter Romania S.A., Cuza-voda street, 99-105, Tg. Mures 540306, Romania;
*Corresponding author: tel. +40-745-231516, fax +40-265-210407; email: silsta@yahoo.com ;


- Abstract -

A rapid and simple high-performance liquid chromatographic assay for the determination of metformin in human plasma was described. After proteins precipitation with perchloric acid, the resulting supernatant was injected onto a cation exchange column and metformin was UV monitored with a recovery greater than 93%. The method had a linear response from 30 to 4000 ng/mL (R2 > 0,999, weighting factor 1/c). The within and between-run variation coefficients were below 5% and accuracy within 9%. Stability over seven months below the temperature - 20 C was demonstrated. The method was suitable for clinical investigation and monitoring of concentration in human plasma after oral administration of 850 mg metformin.
- metformin
- plasma
- HPLC
- bioequivalence
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12. EXPERIMENTAL RESEARCH ON MICE REGARDING THE ANALGESIC EFFECT OF MELATONIN.
ANDREEA LETITIA NITULESCU-ARSENE1, NICULINA MITREA1, AURELIA CRISTEA2, CRISTINA MANUELA DRAGOI1.

University of Medicine and Pharmacy "Carol Davila", Faculty of Pharmacy Traian Vuia 6, Sect. 2, Bucharest:
1Department of Biochemistry;
2Department of Pharmacology and Clinical Pharmacy.


- Abstract -

The great pharmacologic and physiopathologic potential of melatonin (the main pineal hormone) constitutes the object of modern research regarding organisms' integration mechanisms within the great informational variety of the environment. Recently, melatonin has been suggested to play a regulatory role in organisms' pain sensitivity. The present study aims at investigating the antinociceptive activity of melatonin. We also performed an evaluation regarding the dose-dependent dinamics of the analgesic effect of melatonin.
Experiments were performed in vivo, using Albino Swiss male mice. Melatonin was administered i.p., in doses of 25, 50 and 100 mg/bw. Pain sensitivity was assessed using the hot-plate test (60°C).
Our experimental results evoked an important antinociceptive action of melatonin. The maximum analgesic effect was obtained for the dose of 50mg melatonin/bw (the results are statistically significant, p<0.01). The present study outlines that melatonin exerts an important, dose-dependent, analgesic action.
- melatonin
- analgesic effect
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13. PROMOTING INTERNATIONAL RELATIONSHIPS IN THE STATE INSTITUTE FOR DRUG CONTROL AND PHARMACEUTICAL RESEARCH -BUCHAREST, ROMANIA (1970 - 1979).
MARIA - GABRIELA SULIMAN, OLIMPIA SANDA.

Agentia Nationala a Medicamentului.
E-mail: maria.suliman@anm.ro


- Abstract -

Under the leadership of Professor Petre Ionescu-Stoian, the State Institute for Drug Control and Pharmaceutical Research (I.C.S.M.C.F.) made itself known for its resolute activity not only for preservation but also for promotion of ongoing relationships with the pharmaceutical sphere in various European countries and other continents as well.
On April 30, 2004, 50 years have been celebrated since the Institute's creation, a time in which it has been noted by a range of international fora it has been in close and ongoing scientific collaboration with, in most diverse areas of research in drug quality control. Ample experience exchanges with specialists in several countries have been carried out, which have become as many opportunities to acknowledge and appreciate Prof. Dr. Petre Ionescu-Stoian's activity.
One aspect of international relationships from 1970 to 1980 that has been less considered so far is that referring to the activity of the I.C.S.M.C.F., Documentation Service, coordinated by Dr. Pharm. Graziella Baicu, who facilitated en entire range of information exchanges through both publication in various foreign specialised magazines of certain scientific works, mainly in the area of the history of pharmacy, achieved by Romanian authors and regular updates of their publishing activity (Pharmaziegeschichtliche Rundschau, supplement of the Pharmazeutische Zeitung West-German specialised magazine).
- The State Institute for Drug Control and Pharmaceutical Research - Bucharest
- international relationships
- history of pharmacy and medicine
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