Abstract:The pharmacological activities of many Punica granatum L. components suggest a wide range of clinical applications for the prevention and treatment of diseases where chronic inflammation is believed to play an essential etiologic role. The current work reports a case study analyzing the effect produced by a magistral formulation of ethanolic extracts of Punica granatum peels on a non-healing chronic ulcer. The complete closure of the chronic ulcer that was initially not responsive to standard medical care was observed. A 2% (w/w) P. granatum peels ethanolic extract hydrogel-based formulation (PGHF) was standardized and subjected to physicochemical studies to establish the quality control parameters using, among others, assessment criteria such as optimum appearance, pH range, viscosity and hydrogel disintegration. The stability and quantitative chromatographic data was assessed in storage for six months under two temperature regimes. An efficient HPLC-DAD method was established distinguishing the biomarkers punicalin and punicalagin simultaneously in a single 8 min run. PGHF presented suitable sensorial and physicochemical performance, showing that punicalagin was not significantly affected by storage (p > 0.05). Formulations containing extracts with not less than 0.49% (w/w) total punicalagin might find good use in wound healing therapy.
The present investigation was undertaken to evaluate the therapeutic efficacy and safety of Crominex 3+ (a complex of trivalent chromium, Phyllanthus emblica (Amla) extract and purified Shilajit) in moderately arthritic dogs. Eleven client-owned moderately arthritic dogs in a randomized double-blinded study received placebo or Crominex 3+ twice daily for a period of 150 days. On a monthly basis, each dog was evaluated for arthritis associated pain (overall pain, pain upon limb manipulation and pain after physical exertion) and a full physical exam (body weight, body temperature and heart rate). At the same time intervals, dogs serum samples were examined for biomarkers of kidney (BUN and creatinine), liver (bilirubin, ALT and AST) and heart and skeletal muscle (CK) functions. Findings of this investigation revealed that dogs receiving Crominex 3+ (1000 µg chromium, 15 mg Amla extract and 15 mg purified Shilajit per day in two divided doses) exhibited a significant (P<0.05) reduction in arthritic pain noted as early as after 90 days with a maximum reduction after 150 days of treatment. Pain level remained the same or slightly increased in the dogs receiving placebo. No significant change occurred in physical parameters or serum biomarkers in dogs on placebo or Crominex 3+, which suggested that Crominex 3+ was well tolerated by arthritic dogs. In conclusion, Crominex 3+ significantly (P<0.05) ameliorated arthritic pain and improved quality of life without causing any untoward effects in moderately arthritic dogs. [3][4][5]. OA is an inflammatory joint disease characterized by chronic and progressive cartilage degeneration, osteophyte formation, subchondral sclerosis, hypertrophy of bone at the margins and changes in the synovial membrane, which eventually results in decreased stability, movement, loading, stiffness of joints, lameness and pain [6][7][8][9][10][11][12][13][14][15]. Introduction Anti-Arthritic EfficacyIn the early stages of OA, a progressive depletion of the cartilage proteoglycan leads to a net loss of matrix from the cartilage [16,17]. Breakdown and deterioration of the cartilage have been correlated with increased activities of certain enzymes including the matrix metalloproteinase (MMP). The increased cartilage lesions in OA have also been correlated with the enhanced levels of 14,16]. These cascading events lead to increased friction and inflammation in the joints. To date, there are no serum, urinary or synovial biomarkers that are specific and validated for OA [18].Common signs and symptoms associated with OA in dogs include limping, immobility, stiffness of joints, crepitus, periarticular swelling, palpable effusion, pain upon manipulation of the joint and lameness [10,[19][20][21][22][23][24][25]. The diagnosis of OA in canine patients is based upon history, physical exam and radiographic evidence. Finally, MRI findings reveal the changes of joint and cartilage degeneration consistent with OA [26][27][28][29][30].Canines with OA are treated with multipronged approaches, involving i...
RESUMO -Os medicamentos biossimilares não são classificados como medicamentos genéricos de outro biológico, devido à sua constituição molecular complexa, de tamanho médio a grande, sendo assim difícil de caracterizar. A relevância deste estudo está pautada na preocupação quanto à intercambialidade entre os medicamentos biológicos comparadores e seus biossimilares no SUS, em função das possíveis variações intrínsecas destes medicamentos. Diante disso, foi elaborado um estudo de revisão de escopo seguindo a metodologia proposta e descrita pelo Instituto Jonna Briggs (JBI), visando identificar os principais desafios que os medicamentos biossimilares enfrentam em relação à sua intercambialidade, como: Nomenclatura, Farmacovigilância, Mercado nacional, Regulatórios, Substituição automática, Estudos clínicos, Treinamento. Desta forma, espera-se contribuir com a segurança do usuário, o interesse público, ampliação do acesso aos medicamentos biossimilares e redução de custos usualmente altos dos tratamentos com medicamentos biológicos. Os resultados mostram que, para que haja inserção e aceitação desses medicamentos no mercado brasileiro, é preciso considerar não somente as questões regulatórias, como também 1 Doutoranda do Programa de Pós-graduação da Universidade Federal Fluminense (UFF); 2 Doutora, Professora do Programa de Pós-Graduação em ciências aplicadas a produtos para a saúde da UFF. Orientadora deste estudo; 3 Doutora, Professora do Programa de Pós-graduação em ciências aplicadas a produtos para a saúde da UFF. (Co)Orientadora deste estudo.
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