INFLUENCE OF HUMIC ACIDS AS A FEED SUPPLEMENT ON THE REPRODUCTIVE PERFORMANCE OF SOWS

A study was conducted to determine the effect of dietary natural humic acids as feed supplements in the diet on a sow’s reproductive performance. During the survey, there were followed 26 pregnant and later farrowed sows together with their litters, divided into two groups, 12 of them belonged to the control group and 14 to the test group. In the test group, one month before the expected farrowing of sows (late gestation) to weaning, a commercial feed supplement from dietary humic acids was given. The prevalence of TPWL in the CG was 22.62%, while in the TG it was 17.19%. The prevalence of PWM was 8.45% in the CG, while in the TG it was 3.65%, but without a statistically significant difference. Depending on the sow’s dietary treatment, there did not find a statistically significant influence on reproductive performances between the groups. A balanced sow’s diet in the most sensitive period from farrowing to weaning is of great importance for obtaining improved reproductive performances in sows

Principal Component Analysis to evaluate the stability impact of protein mutations: the case of SARS-CoV-2 K417T mutation

The severe acute respiratory syndrome CoV-2 (SARS CoV-2), which was initially identified in the Wuhan Province, China spread worldwide rapidly. The intense escalation forced the WHO to declare a pandemic with 6.5 million deaths worldwide. The purpose of this study was to examine and analyze the impact of K417T mutation upon SARS-CoV-2 S-protein/hACE2 complex stability through the process of PCA analysis

Principal Component Analysis to evaluate the stability impact of protein mutations: the case of SARS-CoV2 K417T mutation

The severe acute respiratory syndrome CoV-2 (SARS-CoV-2), which was initially identified in the Wuhan Province, China spread worldwide rapidly. The intense escalation forced the WHO to declare a pandemic with 6.5 million deaths worldwide. The SARS-CoV-2 virus has a wide host range, as it uses the angiotensin-converting enzyme 2 (ACE2) as a target receptor in humans. Several RBD residues mutated independently in multiple lineages. SARS-CoV-2 variants possess strong virulence and infectivity and can produce immune escape

Priprava i evaluacija hidrogela s diazepamom za rektalnu primjenu

Diazepam (DZP) has become a commonly used drug for treatment of acute repetitive epileptic seizures and febrile convulsions in children. Considering the advantages of rectal administration of DZP, the objective of our study was to formulate and evaluate rectal hydrogels containing DZP as a drug substance in combination with suitable co-solvents and preservatives. Prepared HPMC (hydroxypropyl methylcellulose) hydrogels containing different concentrations of DZP (2, 4 and 6 mg mL-1) manifested good quality in respect to physico-chemical parameters (pH value, drug content, ingredients content and viscosity), antimicrobial efficiency and microbiological quality. Under the proposed HPLC conditions, satisfactory separation of DZP and the preservatives used was achieved. In vitro release studies have shown that the total amount of DZP was released in a period of 3 h. Prepared formulations were stable for four months at 26 oC (ambient temperature characteristic of the 2nd climate zone).Diazepam (DZP) je ljekovita tvar koja se upotrebljava u terapiji akutnih epileptičkih napada i febrilnih konvulzija u djece. U radu je opisana priprava i evaluacija hidrogela za rektalnu primjenu s diazepamom i odgovarajućim pomoćnim tvarima i konzervansima. Pripravci su sadržavali različite koncentracije DZP (2, 4 i 6 mg mL-1). Njihova fizičko-kemijska svojstva (pH vrijednost, sadržaj ljekovite i pomoćnih tvari, viskoznost), antimikrobna učinkovitost i mikrobiološka čistoća bili su zadovoljavajući. Razvijena je HPLC metoda kojom je postignuta separcija DZP i konzervansa. In vitro ispitivanja su pokazala da se cjelokupna količina DZP oslobodi tijekom 3 h. Pripravci su bili stabilni 4 mjeseca na temperaturi 26 C (sobna temperatura karakteristična za 2. klimatsku zonu)

Model framework for off label use of medicines

Background The drug licensing regulatory system ensures that marketed drugs to be used, meet the high standards and requirements for quality, efficacy and safety. Unfortunately, in practice, prescribers are often obliged to deviate from granted medicine marketing authorisation, due to the lack of availability of appropriate medicines for patient’s therapeutic needs and progress. This concept of medicines use not mentioned in the approved labelling (FDA Modernization Act) or outside of the terms of Summary of Product Characteristics regarding indication, age, dosage, pharmaceutical form and route of administration (British NHS Guideline) is defined as off-label use of licensed medicines. On the global level, many supportive evidence and health care needs confirm that off-label medicines use occurs in every country and each level or specialty area of healthcare (Conroy, 2003). Moreover, it is an integral part of Good Medical Practice and may provide the best available option or even the standard of care in a particular health condition (Dresser and Frader, 2009). In general, this concept is legal and may be appropriate, but it can be associated with safety, clinical and ethical concerns, emphasizing the increased incidence of adverse events associated with off-label medicines uses in particularly vulnerable patient groups (Gazarian and Kelly, 2006). A concerning issue is that the majority of all off-label uses have limited to no scientific support (Radley et al., 2006) and a considerable number of prescribers have no or limited knowledge about off-label medicine use or do not meet regulations regarding off-label use, if they exist. (Piñeiro Pérez et al., 2014). Experience shows that to ensure the quality of off-label use of medicines, there should be a formal mechanism to assess the feasibility, monitoring the safety and efficiency of medication used based on this concept.Thus, in continuum, the off-label use of medicines has been an essential part of the ethical and legal considerations as well as, many regulatory initiatives. The overall objective is to present a model regulatory framework setting out guidelines and recommendations for quality use of off-label medicines within the national profile of health care policy. A literature search was undertaken to identify the issues and challenges related to off-label medicines use including clinical, safety and ethical concerns. Recommendations for model framework Principles of good practice for off-label use of medicines should include the following elements: identifying the medical needs; compilation of a consensus list of accepted, scientific based off-label uses; creating an official expert group for the evaluation and approval of specific offlabel uses; and, providing a safe and effective supply. The main guiding principles and developed activities to support a responsible decision-making with regard to off-label medicines include: 1) the medical need- the best avail- S7 OP 290 608 Maced. pharm. bull., 62 (suppl) 607 - 608 (2016) Oral presentations Continuing professional development able treatment in cases of specific characteristics when authorized medicines cannot meet the patients’ need; 2) sufficient scientific basis and/or clinical practice experience to justify their action. Distinguish the routine off-label use, which is the use of these medicines based on “high quality” evidence and the use in specific exceptional circumstances; 3) information duty and a high degree of respect for patient rights, involving the patient/carer in decisionmaking process; 4) monitoring and reporting the outcomes, efficiency and adverse reactions; 5) considering self-monitoring of prescribing practices, liability and accountability. An additional special responsibility which among others falls on pharmacists should be to ensure that the prescriber is conscious for off-label prescribing and the reasons for that 6) production of compendia of certain medicines, enlisting those off-label uses judged to be legitimate.7) financial sustainability of an off-label use in medical practice. Before deciding to compound a patient-specific preparation, a step by step evaluation of alternatives should be made. These alternatives include a therapeutic alternative, dose rounding or manipulation of licensed dosage forms (splitting tablets, crushing tablets/opening capsules, dispersing their content in water or food, splitting suppositories, the use of a preparation designed for another route of administration). Conclusion Prescription, compounding, dispensing and administration of off label use of medicines should be regulated within the national profile of health care policy. The regulation regarding the practice of off-label medicine use differs between countries. Some countries have this practice regulated by law, while in others it is covered by good practice regulations or general professional recommendations and ethical standards. Assuming that there is no any general rule to regulate the “accurate” offlabel use of medicines it is of paramount importance for the countries to find a national solution to fulfil the ethical and legal demand, especially in the areas of pharmaceutical law and health insurance law. The common elements of these regulatory frameworks are the physicians’ freedom to prescribe off-label medicines if the scientific evidence exists and the need to inform patients when making this decision. Making policy efforts, by adopting appropriate guidelines for off-label medicines use, based on scientific evidence, with specifications of healthcare professionals’ responsibilities and a registry of off-label drug use in every day practice, would make possible a valuable approach towards ensuring a quality use of these medicines. Recommended solutions, as practiced in some countries, would support prescribes in more direct and active approach to handle the ethical and legal phenomenon associated with the off-label use of medicines

Biodegradation and drug release studies of BSA loaded gelatin microspheres

Certain variations in the process parameters (emulsification time, surfactant concentration) were performed in order to prepare BSA-loaded gelatin microspheres with high loading efficacy and particle size ranging from 1 to 10 μm using a procedure originally employed by Tabata and Ikada. The mathematical modelling of drug release in the presence of collagenase showed a biphasic release pattern, where the rate constant for the initial time release confirmed the influence of the particle size and/or enzymatic degradation rate on drug release rate. © 2002 Elsevier Science B.V. All rights reserve

Factorial design analysis and optimisation of alginate—Ca-chitosan microspheres

The purpose of this study was to apply factorial design in order to determine the influence of the formulation factors and their interactions on several responses such as particle size, dissolution behaviour at pH 1.2 and pH 7.4 as well as production yield, during the development of budesonide loaded, chitosan coated Ca–alginate microparticles (MPs) intended for treatment of inflammatory diseases in the gastrointestinal tract. Produced drug-loaded MPs were spherical in shape, had smooth surfaces with low porosity and size range between 5 and 11 μm. Production yield for the formulations from the design varied from 19% to 50%. Optimisation was performed using central composite design setting the targets: particle size at 5.5 μm, maximised yield, suppressed dissolution at pH 1.2 and sustained release at pH 7.4. The optimised batches were identified with a combined desirability value of 0.967

Biopharmaceutical characterization of povidone-iodine liposomes

Different formulations of multilamellar liposomes were prepared from Soya lecithin and poly(l-vinyl-2- pyrrolidone)iodine complex by a mechanical method, vortexing the phospholipid dispersion in water. Biopharmaceu�tical evaluation and antimicrobial efficacy studies were performed in order to evaluate liposome's potential for use as a sustained release depo with efficient and prolonged antimicrobial action, compared to PVP-I solution. Varying the drug/phospholipid ratio during the preparation of the liposomes, different efficacy of PVP-I encapsulation was achieved. Lower concentrations of PVP-I in the lecithin dispersion for liposome preparation resulted with higher in�corporation efficacy. Dissolution test results point that total drug release (%) from the series within 24 hours was 45.08 ± 1.53, 36.15 ± 1.65, 22.54 ± 1.96, 19.98 ± 1.05 for series A, B, C and D, respectively. The in vitro microbi�ological testing demonstrated good antimicrobial efficiency of PVP-I liposome dispersions against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Candida albicans. Also prolonged antimicrobial action, compared to PVP-I solution was noticed