Breast Cancer Vaccine: Are We There Yet?

In lieu of an abstract, here is the article\u27s first paragraph: Breast cancer is the most fatal form of cancer for female population worldwide. National Cancer Institute (NCI) estimates 226,870 females and 2,190 males to be diagnosed with breast cancer in the United States by the end of 2012. The estimated death toll for this year includes 39,510 females and 410 males, as reported by NCI. Statistics state that 1 in every 8 females will be diagnosed with breast cancer during her lifetime. These alarming numbers have provoked a large number of scientists to contribute towards the fight against breast cancer. Today there are various tools available for females to protect them from breast cancer. Mammography serves as an efficient tool in screening and catching such cases early enough for improved treatment, while surgery, radiotherapy and chemotherapy provide a strong line of treatment to breast cancer patients. Cancer patients are often subjected to a combination of such therapies, leading to cumulative adverse effects accompanied with the treatment. Addressing the growing number of breast cancer cases, the adverse effects associated with current therapies and the risk of having a relapse after undergoing extensive conventional therapy, researchers are now looking forward for a breast cancer vaccine [1-3]

Cancer Vaccines: A Ray of Hope

In lieu of an abstract, here are the article\u27s first two paragraphs: Recent cancer statistics review by Surveillance, Epidemiology, and End Results (SEER) Program by National Cancer Institute (NCI) shows that cancer is the second most leading cause of death after heart diseases. Cancer incidence has grown from 19.2% to 23.3% from 1975 to 2010 (Figure 1)[1]. Lung cancer remains to be the most fatal form of cancer followed by colorectal, breast and prostate cancer in the country (Table 1)[1]. Regardless of several treatment options, cancer remains to be a unique challenge for both patients and the healthcare providers. Several treatment options are available to address this disease now. Chemotherapy, surgery, radiation therapy are still the mainline of treatment plan for cancer patients. Along with these therapies, immunotherapy is being explored as a combination therapy. Immunotherapy allows utilization of patient’s own immune system to combat the disease and⁄or assist in avoiding a relapse. Cancer research and clinical trials are one of the most challenging ones attributed to the nature of the disease state. This editorial is devoted to those, who have dedicated their careers to develop various immunotherapeutic approaches leading to the evolution of cancer vaccines, providing a ray of hope to cancer patients. These cancer vaccines are targeted to boost the immune response of the host further protecting them from the challenges posed by cancerous cells. Unlike vaccines for infectious diseases, a cancer vaccine is targeted against host’s own cells. Thus, identification and isolation of such cancer antigens is not only difficult but also unique for the patient at times

Pharmacovigilance of Biosimilars

In lieu of an abstract, here is the article\u27s first paragraph: Biotech industry forms the backbone of the current pharmaceutical products. Seven out of top ten anticipated drugs of the industry in 2014 will be biologics [1]. Considering the fast pace growth of the biotechnological products, there is a parallel demand of biosimilars. As defined by FDA, “A biosimilar is a biological product that is highly similar to a U.S.-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product” [2]. Thus these biosimilar products become affordable alternatives to several biotechnological products, which are going off-patent. Along with the benefit of cost-effective therapy and scope of further research leading to the possibility of bio-superiors, biosimilars have led to formation of a whole new branch of biotech industry. However, there are various other concerns that require these biosimilars to be monitored closely

Rupture Test and Bioavailability of Oil-Soluble Vitamins

In lieu of an abstract, here is the article\u27s first paragraph: Bioavailability of multi-vitamins as dietary supplements has always been a concern. Dissolution studies have been successfully used to predict drug release of bioactive molecules, but with vitamins there are some exceptions. United State Pharmacopoeia (USP) defines the dissolution requirements of multi-vitamin supplements based on the composition and type of dosage form. As oil-soluble vitamins do not meet the criterion of “dissolution”, the performance of dosage forms containing such vitamins is evaluated by disintegration studies primarily. Dissolution studies are not applicable for such dosage forms [1]

Micro- and Nanoparticulate Cancer Vaccines: A Vision for the Future

In lieu of an abstract, here is the article\u27s first paragraph: Formulation scientists are constantly challenged with unique opportunities to deliver chemotherapeutic drug molecules to cancer patients. With the growing rate of cancer diagnoses, new therapies are being introduced to pave their way to the market. Along with drug delivery, these formulation approaches are being screened for formulation, design, and development of cancer vaccines. Can a vaccine be formulated to obtain a protective or therapeutic immune response against cancer

Stability of extemporaneously prepared cinacalcet oral suspensions

Purpose The stability of extemporaneously prepared cinacalcet suspensions over 90 days was evaluated. Methods Cinacalcet 5-mg/mL suspension was prepared by triturating 30-mg cinacalcet tablets. Twelve 30-mL batches were prepared with a 1:1 mixture of Ora-Plus and either Ora-Sweet or Ora-Sweet SF (sugar free). Three suspensions of each kind were stored at both room temperature and refrigerated conditions. A 1-mL sample was taken from each bottle at 0, 7, 18, 32, 64, and 90 days. Each sample was assayed using high-performance liquid chromatography (HPLC). A new HPLC method for evaluating drug peaks of pure cinacalcet was developed. Stability was defined as retention of at least 90% of the initial drug concentration. Results The HPLC method established in this study serves as a novel assay for evaluating cinacalcet oral suspensions. For all suspensions tested at individual conditions, the concentration remained above 90% of the initial concentration for 90 days of storage with the exception of Ora-Plus and Ora-Sweet SF suspensions stored under refrigeration, which were stable for 64 days. Usual sedimentation of the suspensions occurred over time but resolved with agitation; there was no other change in visual appearance of the suspensions over the course of the 90-day study. The color and odor of the suspensions throughout the study remained unchanged with respect to the initial time point. Conclusion Extemporaneously compounded cinacalcet 5-mg/mL oral suspensions prepared with a 1:1 mixture of Ora-Plus and either Ora-Sweet or Ora-Sweet SF and stored in 2-oz amber polypropylene plastic bottles were stable for at least 64 days at room temperature and under refrigeration

Evaluation of Microparticulate Ovarian Cancer Vaccine via Transdermal Route of Delivery

Ovarian cancer is the fifth most commonly occurring malignancy in women, with the highest mortality rate among all the gynecological tumors. Microparticulate vaccine can serve as an immunotherapeutic approach with a promising antigenic delivery system without a need for conventional adjuvants. In this study, a microparticulate vaccine using whole cell lysate of a murine ovarian cancer cell line, ID8 was prepared by spray drying. Further, the effect of interleukins (ILs) such as IL-2 and IL-12 was evaluated in a separate study group by administering them with vaccine particles to enhance the immune response. The vaccine microparticles were administered to C57BL/6 female mice via transdermal alone and in combination with the oral route. The transdermal vaccine was delivered using a metallic microneedle device, AdminPen™. Orally administered microparticles also included an M-cell targeting ligand, Aleuria aurantia lectin, to enhance the targeted uptake from microfold cells (M-cells) in Peyer\u27s patches of small intestine. In case of combination of routes, mice were given 5 transdermal doses and 5 oral doses administered alternatively, beginning with transdermal dose. At the end of vaccination, mice were challenged with live tumor cells. Vaccine alone resulted in around 1.5 times tumor suppression in case of transdermal and combination of routes at the end of 15th week when compared to controls. Inclusion of interleukins resulted in 3 times tumor suppression when administered with transdermal vaccine and around 9 times tumor suppression for the combination route of delivery in comparison to controls. These results were further potentiated by serum IgG, IgG1 and IgG2a titers. Moreover, CD8+ T-cell, CD4+ T-cell and NK (natural killer) cell populations in splenocytes were elevated in case of vaccinated mice. Thus, vaccine microparticles could trigger humoral as well as cellular immune response when administered transdermally and via combination of route of delivery. However overall, vaccine administered with interleukins, via combination of route, was found to be the most efficacious to suppress the tumor growth and lead to a protective immune response

The Use of Podcast as a Teaching Tool for a Pharmacy Compounding Pre-Laboratory Lecture: A Survey Based Study

Objective: To determine the opinions of pharmacy students towards use of podcast as a replacement to a traditional pre-laboratory lecture for a compounding course. Methods: Second year pharmacy students were asked to view a podcast prior to their laboratory section as a replacement to an in-class pre-laboratory lecture. A voluntary survey was administered to obtain student feedback regarding the usefulness of podcasts and preferences for its use in future. Results: A total of 192 out of 232 students responded to the survey conducted during 2011, 2012 and 2013. Of these, 94% of respondents reported viewing entire/ parts of the podcast. Total of 44% viewed it multiple times. Of the students who watched the podcast, 91% reported it was an effective learning tool, and 47% suggested podcasts should be used as a replacement to traditional, in-class lectures. Conclusions: Students responded positively and preferred the podcast as either a replacement or as a supplement to traditional in-class lecture

Mucosal Delivery of Particulate Breast Cancer Vaccine

Vaccination has been widely used as a mode of protection against various diseases by taking advantage of host\u27s immune system. Even though vaccination has provided relief from many infectious diseases, vaccination for cancer still remains a challenge. Cancer is caused by mutated cell functioning leading to uncontrolled growth in the organ of genesis and further possible metastasis worsens the situation. In spite of various current therapies such as surgery, chemotherapy and radiation therapy, we are still lacking behind in the race with this evolving disease. There are two major approaches for vaccination: prophylactic or therapeutic. Prophylactic vaccines find their applications in the prevention of viral, bacterial, or parasitic infectious diseases such as influenza, HIV, tuberculosis, malaria, pneumonia, polio, small pox, etc., which are caused by foreign antigens. However, in the case of cancer, which is caused by mutated self-cells, vaccine formulation is a challenging task as it requires immune response against self-cell antigens without causing auto-immune response

Pharmacovigilance of Biosimilars

In lieu of an abstract, here is the article\u27s first paragraph: Biotech industry forms the backbone of the current pharmaceutical products. Seven out of top ten anticipated drugs of the industry in 2014 will be biologics [1]. Considering the fast pace growth of the biotechnological products, there is a parallel demand of biosimilars. As defined by FDA, “A biosimilar is a biological product that is highly similar to a U.S.-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product” [2]. Thus these biosimilar products become affordable alternatives to several biotechnological products, which are going off-patent. Along with the benefit of cost-effective therapy and scope of further research leading to the possibility of bio-superiors, biosimilars have led to formation of a whole new branch of biotech industry. However, there are various other concerns that require these biosimilars to be monitored closely