Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions.
Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.
There has been an increase in demand for caregiver dosage forms over the past two decades. In the oral cavity, mouth dissolving film dissolves swiftly. Oral films that dissolve in your mouth function best when combined with medications that act quickly, such as Xanthine category drugs (Salbutamol Sulphate) and Xanthene Derivative Theophylline. According to the World Health Organization (WHO), asthma affects one in six adults and a quarter of all children, according to the WHO. A child’s admission to the hospital is often due to asthma, which is one of the most prevalent reasons for admission. During an asthma attack, quick-relief or rescue drugs are used to relax and open the airways, as well as ease symptoms. If prescribed, these medications can also be administered prior to exercise. To treat asthma, a combination of Salbutamol Sulfate and Theophylline is available in tablet form under the brand name “Theo-Asthalin.” Oral films seem to be the most efficacious formulation. As a consequence, children with asthma should receive support from drugs given in the form of mouth-dissolving films, since they provide better patient compliance and an appropriate treatment method.
The effect of prepared Ayurvedic formulation was evaluated on excision and incision wound models in rats. The wound-healing activity was assessed by the rate of period of epithelialization and skin-breaking strength. Histological study of the granulation tissue was carried out to know the extent of collagen formation in the wound tissue. The Ayurvedic formulation prepared was then promoted for woundhealing activity in two wound models. The treated animals showed a significant reduction in the wound area and faster rate of epithialisation. In an incision wound model, formulation treated animals demonstrated a significant skin-breaking strength. Histological studies of the tissue obtained from the formulation treated group revealed that the activity was more significant in this group. Our present study reveals that the Ayurvedic formulation posses a potent wound healing activity, which could be a good choice of remedy for wound healing but less potent than standard nitrofurazone.
Parkinson’s disease is an extrapyramidal motor disorder leading to progressive degeneration of neurons in substantia niagra, pars compacta and the dopaminergic tract. The most promising drugs used to treat Parkinson’s disease, i.e., levodopa and entacapoe have very low oral bioavailability because of first-pass metabolism, therefore to increase the bioavailability of levodopa and entacapone, these were incorporated in transdermal patches. Different formulations of the levodopa and entacapone drugs were prepared with different polymeric ratios, by using the solvent casting method and the formulations were evaluated for in-vitro and in-vivo tests, which focus on drug release and drug excipient compatibilities. Various models were applied to ascertain the kinetics of drug release by using in-vitro release data. Nine formulations were prepared and evaluated out of which F6 was found to be the best formulation, which contained HPMC and ethyl cellulose in the ratio of 2:3. It showed drug release of 99.11% in about 12 hours.
Pharmaceutical industry had very responsible job to develop therapies related for COVID-19 related therapies. This responsibility was completed successfully with minimum time for drug approval and review process compared to any other traditional vaccine development plan. This article summarise the challenges Pharmaceutical companies and regulator faced to meet urgent crises in pandemic. It also gives information about the current ongoing major studies for COVID-19.
<abstract><sec> <title>Background</title> <p>Neurometabolic diseases are the results of genetic changes that lead to an imbalance in energy utilization and metabolism.</p> </sec><sec> <title>Aim</title> <p>Our aim was to explore the update in treatment and diagnosis of neurometabolic disease.</p> </sec><sec> <title>Methods</title> <p>PubMed, Scopus, Google scholar, and the web of science were searched for studies reported in the last 20 years (1997–30/10/2020). The data was searched and archived by keywords like “Neurometabolic”, “neurogenesis”, and “role of neuro-degeneration in neurometabolic disease” without narrowing or limiting search items. Only abstracts of searched publications were reviewed. A total of 389 publications were found in the initial research, in which 62 publications were considered for the study and the remaining were excluded because of their specificity to the subject.</p> </sec><sec> <title>Study update</title> <p>The neurometabolic disease affects one in 500 newborns, causing a major burden of illness and infant mortality. However, the cause of the disease is unclear in up to 50% of neurological-like cases. Thus, we ask why are they referred to as neurometabolic disorders (NMD), despite extensive genetic and biochemistry investigations? Treatment is possible for some metabolic diseases. For instance, the devastating neurological effects of phenylketonuria have been recognized for many years. Except for some notable exceptions, treatment remains largely unsatisfactory. Therefore, research efforts concentrate on corrective genetic approaches applicable after early detection by newborn screening or before fertilization. We considered recent studies on treating neurometabolic diseases. We focused on the most common neurometabolic diseases and the associated clinical advancements in their therapy.</p> </sec></abstract>
Due to poor solubility, many drugs are not able to produce the desired effect those drugs are categorized into Biopharmaceutical Classification System Class II drugs. For the enhancement of their solubility, cosolvent technology and development of double-layer tablet technology play a very important role. For enhancement of dissolution, the various methods can be used by which we can increase the solubility, by which we can increase the surface area or the methods such as lipid emulsion and microemulsion can be used. The most promising method for developing sustained-release and controlled-release combination formulations is two-layer tablet technology. In this study, different polymer methods can be used for a typical antipsychotics drug for formulation.
Aim: The present study was undertaken with a view to validate the traditional use of Boerhaavia diffusa (BEE) root and Silybum marianum (SME) seeds in combination as a hepatoprotective agent against non‑alcoholic fatty liver disease. Materials and Methods: The alcoholic extracts of BEE roots (150 mg/kg, p.o.) and SME (150 mg/kg, p.o.) seeds were administered to the experimental rats individually and in combination (75 mg/kg + 75 mg/kg), p.o. by dispersing it in 1% tween 80, were given, of different groups respectively. After intoxication with high fructose diet (HFD) fructose solution to the animals orally for 6 weeks serum levels of various enzymes were recorded. Serum levels of aspartate transaminase (AST), alanine amino transaminase (ALT), alkaline phosphatase (ALP), total bilirubin (TB), total protein and cholesterol (CHO) level were assessed. Results: BEE roots and SME seeds extracts exhibited a significant hepatoprotective effect as evident from the decreases of serum AST, ALT, ALP, TB and CHO and increases in levels of TP compared with control group (P < 0.01 or P < 0.05). The effect of combination of both the extract exerts more hepatoprotective as revealed by more level of significance. Conclusions: The present finding suggests that the hepatoprotective effect of BEE roots and SME seeds extract. Key words: Boerhaavia diffusa, fructose, hepatoprotective, non‑alcoholic fatty liver, silybum marianum
Pantothenic acid (PA) is a water-soluble vitamin (Vitamin B) that has recently been investigated in various chemical-induced neurotoxicity studies. The present study was designed to explore the biological importance of PA as a neuromodulator by releasing monoamine oxidase (MAO)-A and MAO-B in kainic acid (KA)-induced status epilepticus and the associated neurodegeneration in mice. The mice were intraperitoneally administered with KA at a dose of 10 mg/kg, and the injection solution was maintained at pH 7.2 ± 0.1 before the injection. Subsequently, the mice were observed for various behavioral changes, such as grooming, rearing, hind limb scratching, urination, defecation, jaw movements, salivation, head nodding, incidence of convulsions, and their latency or any mortality, which were recorded during a 4-h period. Further, the animals were euthanized for biochemical and histopathological analysis. The oxidative stress status was determined by measuring levels of glutathione, superoxide dismutase, nitrites, and catalase enzymes. The MAO-A and MAO-B activities, which represent an indicator of brain memory function, and the level of tumor necrosis factor alpha, which is an inflammatory marker in brain tissues, were also measured. The PA pre-treated mice showed a significant increase in retention with latency, as demonstrated in the passive avoidance test, which indicate its protective effect against the KA-induced cognitive deficit. The results showed that the anti-oxidative and anti-inflammatory potential of PA is due to the change in lipid peroxidation, which may prevent mitochondrial damage in neuronal cell, thereby conferring neuroprotection.
The studies were conducted with an object to develo p stable safe and efficient delivery system for Antifungal drug fluconazole. During the course of s tudies different Amphiphilogel formulations of fluconazole for topical application were prepare d by using sorbitan monostearate (span 60), Tweem 80 and Tween 20, Iso-propyl myristate, purifi ed water. The formulated fluconazole were evaluated for psychorheological characteristic, dru g content, pH, spreadability. The viscosity of different formulations were determined by using Bro okfield Viscometer at 25°C, the viscosity of formulations increases as the surfactant concentrat ion increases. In vitro release studies were carried out using franz diffusion cell at Phosphate buffer pH 7.4 at 50 rpm. The cumulative % drug releases iXSn the formulation were found to be 88.70- 96.48 %. Finally stability studies were carried out for one month’s showed no separati on of gel indicating overall stability. TLC studies clearly indicated thatY there is no any int eraction in formulation.
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