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PELLAMAR research project

Consortium structure: CO - SC PELL AMAR COSMETICS SRL (acronym PELLAMAR), P1 - "Horia Hulubei" National R&D Institute for Physics and Nuclear Engineering (acronym IFIN-HH), P2 - National Institute for Chemical-Pharmaceutical R&D (acronym ICCF).
  • PELLAMAR research project PELL AMAR – A NAME IN SEARCH OF ITS LOST FAME


Project summary


PELL AMAR – A NAME IN SEARCH OF ITS LOST FAME


Finding that sapropelic mud has biotrophic, regenerating, sedative, analgesic, anti-inflammatory properties, Dr Ionescu Călineşti had two ideas that led to a Romanian brand of great success in 1970:
a) he inferred the synergistic effect of the combination of minerals, enzymes and organic substances, mainly its holistic healing action;
b) he obtained by atomization, a concentrate with enhanced curative effects.

The extract was called PELL AMAR and was used in over 40 products: pharmaceuticals (including injectables), cosmetics, food supplements. After some clinical trials (1980) PELL AMAR products were used for treating ailments such as rheumatoid polyarthritis, ankylosing spondylitis, cervical, dorsal, lumbar vertebro-peripheral osteoarthritis, gonarthrosis, coxarthrosis, scapulo-humeral periarthritis, tendonitis, synovitis, bursitis, sprains, bruises, dislocations, contusions, psoriasis and localized scleroderma, burns. After 1990 the products disappeared from the market, at the same time with their production infrastructure, and with the legislative changes which cancelled the old authorizations. In 2010, the products reappeared with the establishment of SC PELL AMAR COSMETICS SRL, which in the last 3 years has demonstrated that the sapropelic mud extract can successfully cope with the technical and commercial demands of the cosmetics market. This project aims to increase the quality and competitiveness of PELL AMAR - COSMETICS range, which are already produced and initiate a new category of PELL AMAR – PHARMA range, by significant changes in the technology, base product and derived products and also by upgrading the approach of production, verification and control process.

The basic ideas are:
• Upgrading the technology by:
1) replacing the atomization concentration with the lyophilisation concentration;
2) introducing a new stage of sterilization by irradiation treatment of the lyophilized extract;
• Upgrading and improving the base product - microbial sapropelic mud extract, because both elements of technology modernization will have consequences in product upgrading.
• Introducing regulatory elements that improve the Quality Management System of SC PELL AMAR: standardizing the solid extract and establishing a set of physical, chemical, biological tests that unequivocally characterize the product, by following the model in the European Pharmacopoeia and thus facilitating the authorization of the products in the pharmaceutical range.
• Establishing and demonstrating the manufacturing technology on its range of derived products: - Cosmetics (biotrophic effect, regenerating, sedative); - Food supplements (boost immunity, relieve rheumatic pain)
• Demonstrating the therapeutic effect of a product with topical application (ointment in rheumatic diseases) and initiating the studies necessary to the documentation for changing its categorization from cosmetics to pharmaceuticals. The dissemination of the project results will be one of the tasks of all members of the partnership.

It will be focused on two target groups:
a) persons and institutions having specialized technical & scientific knowledge - scientific articles, patents, national seminar, project’s site; here the focus will be on the technical & scientific results);
b) the general public - articles, interviews in the media, brochures, newsletters, movies, showrooms; here the focus will be on improving the quality of life).

The consortium partners have been chosen according to three criteria: competence, complementarity and cohesion. Competence is proven by certification, accreditation, licensing. Complementarity is needed for solving all the problems that the project will be facing, and cohesion is based on the previous relationships between the partners. Project coordination is undertaken by the economic partner and the project director, an economist, is also the general manager of the economic partner.


Project description

Scientific context and motivation

The lakes with salted water and sapropelic mud as Amara, Lacu Sărat, Techirghiol etc., are extraordinary natural richness of Romania. Healing properties of these places were discovered and used long time ago, but a more efficient exploitation has occurred recently in close connection with investments in infrastructure. Administrative measures appeared to protect these places against anthropogenic pollution and to allow for a rational utilization of the balneary resource under medical surveillance. Recently such areas have been declared “protected natural areas”. Being based on recognition of the necessary compromise between human needs and protection of nature, this concept allows for the classification of protected areas depending on the permitted degree of human intervention which is thus guided and restricted so as to preserve natural characteristics and specificity. Balta Alba Lake – Buzau County, is such a natural resource of health. The lake is placed in NATURA 2000 ROSCI 0005 site and has the status of protected area under Law 5/2000 (IV IUNC, b,z,u, CJ 13/1995) [WWW CDEP; WWW MMEDIU] – habitats/species management area specially administrated for conservation by management interventions.

Historical landmarks:
• Important persons like Alexandru Ioan Cuza – the ruler or Vasile Alecsandri – the poet, are connected with the history of Balta Alba Lake, where a balneary complex was recorded in the 19th century. Around 1870 the nearby village with a suggestive name – Baile (Eng – the Bath), had a hotel, villas, a casino, 200 rooms and 400 treatment places etc. For 40 years, before the First World War started, Balta Alba Lake seemed to become a famous European balneary resort.
• The two World Wars, the social and political changes in Romania and in Europe, the evolution of medicine and even of fashion, led to forgetfulness and degradation of Balta Alba balneary complex.
• It was only in the 1970’ that a man and his ideas brought Balta Alba Lake back to life. The man was dr Stefan Ionescu Calinesti. Finding that sapropelic mud has biotrophic, regenerating, sedative, analgesic, anti-inflammatory properties, he decided to intensify the effects by concentrating the raw material. Studying the role of mud components he also intuited the synergistic effect of the group of minerals, organic substances and enzymes in a curative holistic action. This led to the idea of obtaining a concentrate/extract by atomization. The extract was named PELL AMAR and had an astounding career, being patented [Ionescu Calinesti patent no. 57619/1971 and 57713/1971] and used as basic ingredient for over 40 health care products. For two decades PELL AMAR products were preferentially prescribed for instance in the treatment of chronic and degenerative inflammatory rheumatic diseases, but also for many other diseases [Agarbiceanu et al. 1975, Anitei et al. 1986, Ape&Namoluri 1973, Balneo&Fizio 1972, Balneo Resorts 1978, Ioan et al. 1973; Ionescu Calinesti 1971, 1977, 1978, 1979, 1980, 1981 (Bucharest & Quebec), Modval et al. 1970, Nestor et al. (Bucharest & San Francisco) 1977, Papa et al. 1975, Prunescu 1982, Teodoreanu et al.1984].
• After 1989 a time of matching and connection to the European procedures and practices began for the Romanian pharmaceutical field. New concepts started to be applied as GMP (Good Manufacturing Practice) or GLP (Good Laboratory Practice). This approach extends from the pharmaceutical production area and equipment, drug validation testing, to the structure of the personnel in the drug factory or of the marketing file. All the modifications required by this new legislation involved important costs for improving the production line, retesting and completing the products, implementing a quality management system and strict operation procedures. Under such circumstances, PELL AMAR products ceased to appear on the market since 1994.
• S.C. PELL AMAR COSMETICS SRL was established in 2010, starting to capitalize on the history of PELL AMAR brand. The company identified the possibility to manufacture and release on the market cosmetics using PELL AMAR extract obtained by the former technology. For cosmetics, the legal constraints in manufacturing are less costly than for drugs. Instead, the competition is harsh. This means that such market experience is a good test to explore what was left of the fame of PELL AMAR brand. The conclusion of this experience extended over the last 3 years is unequivocal: PELLAMAR brand is still viable.

Based on the above conclusion this project intends to improve brand competitivity by:
- Technological innovation resulting in the improvement of sapropelic mud extract qualities (better products);
- Proving the pharmaceutical potential of PELLAMAR products: demonstration of the therapeutic effect on a topical product using the biomarker technique (increasing the offer);
- characterizing the chemical and microbiological composition and standardizing the control methods for the mud extract (the extract will be registered in the international nomenclature of cosmetic ingredients – INCI and may be marketed as such).
After the innovative technology becomes operational at CO premises, it will be possible to design a production strategy for pharmaceuticals and food supplements.

Bibliography (selection)
[Agarbiceanu et al. 1975] Agarbiceanu, T., Andries, M., Andries, V., Baican, I., Bazilescu, I., Berceanu St., Berlescu. E., Chirvasie, L., Conu, A., Degeratu, C., Dinculescu, Tr., Gheorghiu, N.N., Hoanca, V., Ivanescu, Tr., Milcu, St., Moldovan, S., Persache, C., Pilat, I., Robos, G., Sbenghe, T., Stoicescu, C., Sdie, L., Teleki, N., Voiculescu, C., Indicatii si contraindicatii de trimitere la cura balneoclimatica, Ministerul Sanatatii, Institutul de Medicina Fizica, Balneoclimatologie si Recuperare Medicala, Colectiv de Redactie: Dinculescu Tr., Teleki N., Berlescu Elena, Dragan M., Ivanescu Tr., Sbenghe T., Editura Medicala, Bucuresti, 1975.
[Anitei et al. 1986] Anitei, L., Baican, I., Chirvasic L., Conu, A., Degeratu, C., Dumitrescu, S., Florian, M., Samson Sanda, G., Gavrilescu, M., Hoanca, V., Kiss, J., Luca, I., Lucescu, V., Lungu, P., Moldovan, Y.S., Mustata, E., Persache, C., Robos, G., Radulescu, A., Sbenghe, T., Swoboda, D., Swoboda, M., Sdic, L., Teleki, N., Teodorescu, E., Teveanu, E., Cura Balneoclimatica – indicatii si contraindicatii, Ministerul Sanatatii, Institutul de Medicina Fizica, Balneoclimatologie si Recuperare Medicala, Colectiv de redactie: Degeratu, C., Ivanescu, T., Moldovan, S., Baican, I., Editura Medicala, Bucuresti, 1986.
[Ape & Namoluri 1973] APELE MINERALE SI NAMOLURILE TERAPEUTICE DIN R.P./R.S. ROMANA – Ministerul Sanatatii, Institutul de Balneologie si Fizioterapie, Editura medicala, Bucuresti (Vol II – 1965; Vol III – 1970; Vol. IV - 1973).
[Balneo & Fizio 1972] STUDII SI CERCETARI DE BALNEOLOGIE SI FIZIOTERAPIE - Ministerul Sanatatii, Institutul de Balneologie si Fizioterapie, Editura medicala, Bucuresti (Vol V – 1963; Vol VII – 1965; Vol. X – 1969; Vol. XI - 1972).
[Balneo Resorts 1978] The Guide of Balneoclimateric Resorts in Romania, Ed. Sport-Turism, pp. 155, 1978.
[Ioan et al. 1973] Ioan, S., Pell Amar action in thermoregulating rheumatic patients, Climatology Congress Milan, 1973.
[Ionescu Calinesti 1971] Ionescu Calinesti, S., Possibilities of superior turning to account of therapeutical mud, Herculane, 1971.
[Ionescu Calinesti patent no. 57713/1971] Ionescu Calinesti, S., Procedure and installation for obtaining an active product out of therapeutical muds. Patent S.R. of Romania, nr. 57713/1971, 1971.
[Ionescu Calinesti patent no. 57619/1971] Ionescu Calinesti, S., Procedure for obtaining stable peloidic extracts. Patent S.R. of Romania, nr. 57619/1971, 1971.
[Ionescu Calinesti 1977] Ionescu Calinesti, S., Pell-Amar treatment in abarticular rheumatism, Symposium, Tekirghiol, 1977.
[Ionescu Calinesti 1978] Ionescu Calinesti, S., Pell-Amar therapy original method of treatment, based on products of therapeutical mud extracts, Symposium of the Roumanian Original Drug, Bucharest, 1978.
[Ionescu Calinesti 1979] Ionescu Calinesti, S., Natural biostimulators from peloidic extracts, Symposium, Braila, 1979.
[Ionescu Calinesti 1980] Ionescu Calinesti, S., The treatment with Pell-Amar in the degenerative rheumatism, International Symposium of Balneology and Medical Rehabilitation, Herculane, 1980.
[Ionescu Calinesti – Bucharest 1981] Ionescu Calinesti, S., A study regarding the therapeutical efficacy of the Pell-Amar type extract, The 12th Scientific Session of the Academy of Medical Science, Bucharest, 1981.
[Ionescu Calinesti – Quebec 1981] Ionescu, Calinescu, S., Etudes sur la penetration des principes actifs dans la peau. 3-eme Congres annuel de la Federation Quebecoise de l’Esthetique, Quebec – Canada, 1981.
[Modval et al. 1970] Modval, M., Modifications de la teneur en vasopresine sanguine apres certaines methodes balneo-physio-therapeutiques, Regional Congress of the International Union Physiological Sciences, Brasov, 1970.
[Nestor et al. – Bucharest 1977] Nestor I., R., et al., Indications and efficacy of the treatment with the Romanian product Pell-Amar in rheumatic affections, Scientific Session of the Methodologie, Centre of Rheumatology, Bucharest, 1977.
[Nestor et al. - San Francisco 1977] Nestor I., R., et al., The merits of the natural mud extract Pell-Amar in the management of scapulo-humeral periarhritis, The 14th International Congress of Rheumatology, San Francisco, USA, 1977.
[Papa et al. 1975] Papa, V., Pharmacodynamic studies of injectable Pell-Amar, Laboratory for Biological Research and Control, Bucharest, 1975.
[Prunescu 1982] Prunescu, C.C., Morphological and metastructural study on the healing process of tegument lesions in mouse after applying Pell-Amar, 1982.
[Teodoreanu et al.1984] Teodoreanu, E., Grigore, L., Stoicescu, C., Munteanu, L., Teleki, N., Cura balneoclimatica in Romania, Editura Sport – Turism, Bucuresti, 1984.
[WWW CDEP] http://www.cdep.ro/pls/legis/legis_pck.htp_act_text?idt=22636
[WWW MMEDIU] http://www.mmediu.ro/protectia_naturii/biodiversitate/2011-10-20_protectia_naturii_RO_SCI_SDF_2011.pdf


Beyond the state of the art

The beneficial effect on health produced by mineralized waters and sapropelic muds have been used empirically for a long time and began to be researched and studied ever since the eighteenth century (Dr. Lukas Wagner 1773). In time a discipline of complementary medicine appeared - BALNEOLOGY. Specific research methods, a specific terminology and an own classification system supplemented the elements shaping a scientific discipline.
The Romanian riches in this area have led to very early studies (1821 Dr. Ladislaus Pop, 1837 Dr. Stefan Vasile Episcopescu), to the establishment of an Institute of Balneology (after the First World War) [WWW INRMFB] and to specialized scientific publications (Institute of Balneology Magazine, Bulletin for Studies in Hydrology and Balneology) [Dumitrascu 2011, Munteanu 2012, Munteanu et al. 2011, Munteanu and Dumitrascu 2011, Pretorian 2012].
Among the models adopted in balneological we should mention the one that considers the skin to be a physiological cloak having electrolytes. It acts as an ion exchanger between the human body and the zeolites and the humic corpus present in the mud. Inorganic and organic ions (aminoacids for instance) are transferred this way. The analytical methods used are those recommended in the "Romanian Pharmacopoeia" with supplements from soil analysis [WWW WHO]. The book profusely quoted throughout this paragraph discusses the therapeutic indications of the mud in separate chapters devoted to rheumatic inflammatory rheumatic diseases, rheumatic degenerative diseases, abarticular rheumatic diseases, posttraumatic sequelae, neurological, dermatological, gynecological, metabolic, nutritional and endocrine diseases, respiratory diseases.
Unlike allopathic medicine, in the disciplines of complementary medicine, including Balneology, the therapeutic effect cannot be accurately and unambiguously attributed to a well defined active ingredient. The evidence requires the acceptance of holistic therapeutic actions. For example in this case: "Under the action of mud, a harmonic stimulation occurs in all the glands in the sense of increasing enzyme activity and synthesis, also by preserving the specificity of each… Mud spa treatment produces favorable effects that persist for a long time by changing the ability of the adaptative response to various stimuli.... Peloids act on the cardiovascular system, the nervous system and the immune systems ... " [Agarbiceanu et al.1962, Byna 1962, Chadzopulu et al. 2011, Cinteza et al. 2011, Marin et al. 2012, Munteanu and Cinteza 2011, Surdu 2007, Teleki et al. 2004].
Another characteristic of complementary medicine is that the therapeutic effect occurs slowly, which means that therapeutic factors are found in low concentration. It is interesting to note that in the disciplines of complementary medicine the therapeutic effects are described in rigorous medical terms, while the manner of recommendation / implementation of the treatment is very lax.
The ideas incorporated into PELL AMAR products are: fully preserving the holistic action, but increasing the concentration of active principles in their entirety, by using a mud extract to manufacture products to improve health, including pharmaceuticals. An indirect contribution to the project is a change in social behavior: one does not go to spa (mud) in his/her annual vacation, but uses cosmetics, special food products or medicines at home as many times as the need to (daily, weekly), thus obtaining increased health benefits at less expensive costs.

Bibliography (selection)
[Agarbiceanu et al.1962] Agarbiaceanu, T., Studies and research works of balneology and climatology, Bucharest, 260-262, 1962. [Byna 1962] Byna, D., Studies and research works of balneology and climatology, Bucharest, 1962.
[Chadzopulu et al. 2011] Chadzopulu, A., Adraniotis, J., Theodosopoulou, The therapeutic effects of mud, Progress in Health Sciences, 1(2) (2011) 132-136.
[Cinteza et al. 2011] Cinteza, D., Lazarescu, H., Brailescu, C., Bunescu, I., Covaleov, A., Diaconescu, S., Dima, A., Enache, L., Enescu, C., Farcas, D., Galbeaza, G., Marcu, V., Mirescu, L., Munteanu, A., Paius,L., Poenaru, D., Popa, A., Popescu, S., Simionca, I., Ghidul Balnear, Editia I, Institutul National de Recuperare, Medicina Fizica si Balneoclimatologie, 2011.
[Dumitrascu 2011] Dumitrascu, M., Artemia salina, Balneo-Research Journal, Editura Balneara, 2(4) (2011) ISSN 2069-7600.
[Marin et al. 2012] Marin, V., Surdu, O., Profir, D., Demirgian, S., Peloidotherapy in Osteoarthritis – Modulation of Oxidative Stress, published in Osteoarthritis – Diagnosis, Treatment and Surgery, Edited by Qian Chen, Publisher: InTech, ISBN 978-953-51-0168-0, 143-156, 2012, doi: 10.5772/2400.
[Munteanu 2012] Munteanu, C., Cinteza, D., Pretorian, S., Lazarescu, H., Hoteten, M., Munteanu, D., Strategie de cercetare a calitatii terapeutice a namolului si apei sarate din Lacul Ursu – Sovata, Balneo-Research Journal, 3(2), Editura Balneara, ISSN 2069-7600, 2012.
[Munteanu et al. 2011] Munteanu, C., Lazarescu, H., Munteanu, D., Bioclimatul solicitant de campie – Statiunea balneoclimaterica Amara, Balneo-Research Journal, 2(2), Editura Balneara, ISSN 2069-7600, 2011.
[Munteanu and Cinteza 2011] Munteanu, C. and Cinteza, D., Cercetarea stiintifica a factorilor naturali terapeutici, Editura Balneara, ISBN 978-606-92826-8-7, 2011.
[Munteanu and Dumitrascu 2011] Munteanu, C., Dumitrascu, M., Namoluri terapeutice, Balneo-Research Journal, 2(3), Editura Balneara, ISSN 2069-7600, 2011.
[Pretorian 2012] Pretorian, S., Calitatea destinatiei - Statiunea Sovata, Romania, Balneo-Research Journal, 3(2), Editura Balneara, ISSN 2069-7600, 2012.
[Surdu 2007] Surdu, O., Studiu histologic comparativ al actiunii namolului sapropelic de Techirghiol asupra tegumentului, Universitatea Ovidius Constanta, Facultatea de Medicina, Generala, Teza de doctorat, 2007.
[Teleki et al. 2004] Teleki, N., Munteanu, L., Bibicioiu, S., Romania Balneara, Ghid pentru medicii de familie si pentru medicii specialisti, Bucuresti, 2004.
[WWW INRMFB] http://www.inrmfb.ro/index.php?option=com_content&view=article&id=47&Itemid=54
[WWW WHO] http://www.who.int/medicines/publications/pharmacopoeia/WHOPSMQSM2006_2_IndexPharmacopoeiasUpdated.pdf


Project objectives

• Changing the technology for obtaining the sapropelic mud extract for a new pharmaceutical range by:
- Replacing the concentration by atomization with the concentration by lyophilization;
- Introducing a new stage of sterilization by irradiation treatment of the lyophilized extract.
• Obtaining the basic product (sapropelic mud extract) with improved qualities;
• Introducing regulatory and standardization elements in process and product control; implementing these actions in CO QMS (quality management system).
• Demonstrating the innovative technology for manufacturing the lyophilized sapropelic mud extract.
• Demonstrating the therapeutic effect of PELL AMAR active principle.


Project outcomes

• A first expected result is upgrading the technology. Thus,
- by replacing atomization with lyophilization thermal degradation of biogenic components from the mud is avoided;
- the irradiation treatment of the extract ensures microbiological control / sterilization, if necessary, being an indispensable step for having a microbiologically safe product.
• The innovative technology will result in an upgraded product. Both new technological steps have consequences on product quality because:
1) lyophilization leads to a full conservation of the active principles from mud, and to an increased efficiency of the solid extract;
2) radiation therapy leads to a microbial load control (no pathogens), necessary for derived cosmetic or food products; irradiation treatment can be used to obtain a sterile product – useful for certain pharmaceutical products (e.g. injections).
• The standardization of solid extract will be obtained through a better control of the production process, possible in the new technology. Besides the favorable consequences in the quality of cosmetics and food supplements, favorable financial consequences are expected in the diversification of pharmaceuticals which is the subsequent stage of the project. The therapeutic effect will not have to be demonstrated again for every pharmaceutical formulation (ointment, tablet, injectable product).
• Establishing a set of physical, chemical and biological tests that will characterize the sapropelic mud extract. This is an important requirement for any substance used as pharmaceutical raw material. The result of the project is essential for launching the range of PELL AMAR pharmaceutical products.
• The demonstration of the technology will allow for obtaining a sufficient quantity of lyophilized extract to produce and test at least one cosmetic product, at least one food supplement and a (potentially) pharmaceutical product for proving the therapeutical effect.
• Sets of biomarkers will be identified to monitor the rheumatic therapeutic action of the PELL AMAR topic product;
• Tests will be performed to demonstrate the therapeutic effect in rheumatic diseases and to identify the mechanism of action for a product with topical application - ointment. An adapted cosmetic product will be used.


Method and approach
Practical relevance of the problem proposed to be solved:
The reason for establishing SC PELL AMAR COSMETICS SRL (CO in this project) was the belief in the possibility to revive the PELL AMAR brand and the products with this name, so much used for 20 years in Romania. To check the viability and the competitiveness of the business idea, CO developed a strategy in stages. In the first stage (2010-2013) the market was tested with cosmetics produced by the technology of the 1970s. Cosmetics belong to a market where competition is harsh. The conclusions were:
a) It was verified concretely that the idea of concentrating the sapropelic mud is not obsolete and is still commercially competitive;
b) It also became clear that the position and the stability of PELL AMAR products on the market will come from a qualitative advantage as compared to competing products;
c) At the same time, pharmaceuticals will not only fully exploit the therapeutic qualities of the sapropelic mud but will also essentially help in promoting the brand as a whole.
The strategic objectives of the next stage identify with the objectives of this project. They are intended to establish competitive advantages with direct practical effects on sales and future development of the brand by:
- far-reaching technological innovation,
- improving and upgrading the quality of PELL AMAR products,
- proving the therapeutic effect of the sapropelic mud extract, which is the decisive step in obtaining a pharmaceutical product.


Consortium structure

Consortium partners were chosen by three criteria, competence, complementarities and cohesion. Competence is proven by the existence of certifications, accreditations, licenses. Complementarities are necessary to solve all the problems that will confront the project and cohesion is based on previous relationships between partners.

CO - SC PELL AMAR COSMETICS SRL
(acronym PELLAMAR)

Legal exploitation of mud from Lake Balta Alba:
• SC PELL AMAR COSMETICS Ltd, has the license for Lake Balta Alba Exploration / Exploitation no. 13557/2010. It has the Environmental permit no. 82/09.05.2011, which regulates the exploitation limits. These documents indicate exploitation conditions of the sapropelic mud.
• The lake is located into the site Natura 2000 ROSCI 0005 Balta Alba, Amara, Jirlau, Caineni, Lacul Sarat – area of community interest protected by the Order 776/2007. It is overlapped by the protection site ROSPA0004, Balta Alba – Amara – Jirlau established by Governmental Decision 1284/2007. Balta Alba has the status of a protected area by L 5/2000 (IV IUNC, b, z, u, CJ 13/1995) – habitats/species management area specially administrated for conservation by management interventions. CO currently commercializes cosmetics in around 700 outlets, mainly large pharmaceutical chains, small pharmacies, drogeries and naturist stores. Different SPA, propose health packages including PELL AMAR products. CO has implemented a quality management system according to ISO 9001 and GMP 22716, certificate no. SCS.12.P.063.06/Q for cosmetics.

P1 - "Horia Hulubei" National R&D Institute for Physics and Nuclear Engineering
(acronym IFIN-HH)

With a contribution of almost 10% of the national scientific output, IFIN-HH is one of the most important public R&D organizations in Romania. The institute is dedicated to the research and development in physical and natural sciences, mainly Nuclear Physics and Nuclear Engineering, and in related areas including Astrophysics and Particle Physics, Field Theory, Mathematical and Computational Physics, Atomic Physics and Physics of Condensed Matter, Life and Environmental Physics. In all these fields, IFIN-HH conducts theoretical and experimental research. IFIN-HH participates in the project by its department IRASM Radiation Processing Center.
IRASM - IFIN-HH has two Co-60 gamma irraditors and a number of laboratories:
- SVST Co-60 / B, Industrial panoramic irradiator, tote box type (~200 l/box), source activity ~ 300 kCi, batch irradiation capacity 10 m3 per;
- GC 5000, research irradiator, gamma cell type, source activity ~ 10 kCi, irradiation capacity approx. 5 liters;
- Dosimetry Laboratory, two dosimetry systems and traceability to RISO High Dose Reference Lab – Denmark;
- Laboratory of Microbiology, GLP license from 2004, issued by ANM (Romanian Health Regulatory Body, similar with FDA in USA) and accreditation for bioburden and sterility tests, issued by RENAR (Romanian Accreditation Regulatory Body);
- Physical-Chemical Testing Laboratory; QMS (Quality Management System) is certified since 2002 by DQS Germany, cf ISO9001, ISO13485 and ISO11137 and extends to all IRASM activities including R&D.
Project activities related to radiation treatment: experimental irradiation at different doses and different dose rates for characterization / testing samples, establishing product specifications, product dosimetry mapping, process specification establishment. Analytical project activities: microbiological tests, thermal analysis TG/DSC, gas chromatography GC/MS, elemental analysis by ICP-MS technique, ESR spectroscopy, FTIR, FT-Raman.

P2 - National Institute for Chemical-Pharmaceutical R&D
(acronym ICCF)

ICCF was founded in 1949. The institute has a rich tradition and extensive experience in researching medicines, having got a core competence in Romania by its unique capability to perform the entire development of a medicine, from the synthesis to the complete authorization files, competency that has kept it in the present. Until 1990, it was almost the single supplier of new technologies and products to the Romanian pharmaceutical industry.
Though until the 1990's, R&D activity was oriented more towards getting the generics, now the R&D activities include mainly synthesis or isolation from natural sources (microbial and vegetal) of new potential active substances. Apart from drug substances and products for human and veterinary use, some products related by origin and technology, as feed additives, biopesticides, biofertilizers, biopolymers, cosmetics, clinical diagnostic kits and pure reagents have been developed, too. A small-scale production valorizes some original technologies of the institute.
In the past 10 years, the Institute has been lead partner at 53 projects in PNCDI 1, CEEX and PNCDI 2 and partner at another 58 projects in the mentioned programs. It also was a partner in a project network type FP 5, is a partner in two projects of the FP 7 and also participates in the two projects from structural funds.

P3 - National Institute of R&D in the Pathology Domain and Biomedical Sciences "Victor Babes"
(acronym IVB)

IVB, founded in 1887, is the first institute of biomedical research in Romania. The mission is to conduct cutting-edge research in the field of molecular and cellular medicine for the knowledge-based scientific progress using instruments and solutions in the benefit of patients and society. The institute uses "state of the art" methodologies, to develop innovative diagnostic tools, and personalized medicine strategies in tumor pathology. The advantage of having infrastructure and experts in different disciplines, is that we can adjust our projects along the way, depending on the priorities related to patient needs and in conjunction to the European scientific trends. It is our commitment to be integrated in large scale multidisciplinary projects in biomedical science, aiming at improving health and the quality of life.
In the last 5 years, were produced more than 150 publications in ISI journals; research excellence in the field of life sciences being sustained by:
- international projects: 1 FP7 PIRSES, 4 bilateral projects, 1 MNT-ERA NET project, 1 project in the EU Education Lifelong Learning Program, 1 NATO project.
- structural funds for research : 2 POSCCE projects.
- projects financed by the European Social Fund: 3 projects focused on the training in biomedical techniques, aiming to implement new diagnosis tools in clinical laboratories.
- projects financed by the national research programs – 125 projects. The institute was awarded several international prizes for patents in innovative therapies. Patents: 3 registered and 4 submitted.
The institute is certified ISO 9001:2008; The Biochemistry-Proteomics Laboratory is accredited for performing research and medical services according with SR EN ISO 15189:2008.

The "state-of-the-art" technology, available in these laboratories, and the expertise of the team allow complex, interdisciplinary studies such as the one in the present research grant.


Specialists
CO (PELL AMAR) Project leader:
Nicu STOICA, 45 years, Economist, Director General SC PELL AMAR COSMETICS SRL
CO (PELL AMAR) Key Person:
Iuliana HARASIM, 52 years, 28 years expertise in R&D, chemical engineer specialized in cosmetics and parfumery.
P1 (IFIN-HH) Team Leader:
Marian VIRGOLICI, 34 years, PhD, Scientific Researcher III at IFIN-HH, with 10 years of experience in research.
P1 (IFIN-HH) Key Persons:
Ioan Valentin MOISE, 43 years, Scientific Researcher III (17 years in research, specialist in radiation processing, expert IAEA-Vienna for European co-operation projects), IRASM Department (IFIN-HH Radiation Processing Center) Head, PhD student (Univ. of Buc.), MSc in Electronics-Physics, BS in Physics.
Mioara ALEXANDRU, 34 years, PhD, Scientific Researcher III, specialist in microbiology and molecular biology, head of IRASM Microbiology Laboratory.
P2 (ICCF) Team Leader:
Radu ALBULESCU, 58 years, PhD, Scientific Reasearcher I and Head of department at the National Institute for Chemical-Pharmaceutical R&D (ICCF), Scientific Reasearcher I in the Laboratory of Biochemistry-Proteomics at the Victor Babes National Institute of Pathology (IVB), Bucharest, 24 years of experience in research and 10 years in development within a drug company.
P2 (ICCF) Key Persons:
Sultana NITA, 63 years, PhD, Scientific Researcher I (ICCF), Expertise in analytical techniques (FTIR, UV-VIS spectrometry, HPLC-DAD, HPLC-MS, UPLC-MS).
Alice GRIGORE, 36 years, PhD, Scientific Researcher III, fundamental and applied research activity in the medicinal plant research area.
P3 (IVB) Team Leader:
Elena CODRICI (RADUCAN), 35 years, PhD, Scientific Reasercher III, 11 years of experience in research and laboratory techniques.
P3 (IVB) Key Person:
Cristiana TANASE, 61 years, PhD in Medical Sciences (University of Medicine and Pharmacy "Carol Davila", Bucharest), head of the Laboratory of Biochemistry (Department of Proteomics), 25 years of research.


Career development
Page under construction.


Acknowledgements
Project was financed by:
UEFISCDI - Partnership in S&T priority domains Joint Applied Research Projects (2013 Competition)
Project code: PN-II-PT-PCCA-2013-4-1470
Contract No.: 265/2014
Project title: PELL AMAR – A NAME IN SEARCH OF ITS LOST FAME


Materials & Resources

Scientific reports

1.Raport stiintific si tehnic in extenso privind implementarea proiectului PN-II-PT-PCCA-2013-4-1470 (contr. 265/2014) in perioada iulie – decembrie 2014


 
 

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Biocosmeticele Pell Amar valorifică superior una din bogăţiile naturale ale României şi anume extractul Pell Amar
obţinut din nămol sapropelic de către prof. dr. IONESCU CĂLINEŞTI. Extractul natural de nămol sapropelic este un complex mineral organic şi enzimatic cu proprietăţi biotrofice, regeneratoare, antiinflamatoare, analgetice, sedative şi vasodilatatoare demonstrate atât experimental cât şi în cercetări clinice.