Adopting a Healthy Lifestyle Essay Example | Topics and Well Written Essays - 1250 words

Adopting a Healthy Lifestyle - Essay Example The healthy lifestyle includes good feeding practices by eating a balanced diet, avoiding junk food†¦ doing regular exercise†¦Ã¢â‚¬  (Landow, 76) Thus, adopting a healthy lifestyle is important to resist different kinds of health problems and it is only possible if we eat a balanced diet, exercise and avoid stress. A balanced diet is essential for adopting a healthy lifestyle. Everyone has certain food preferences and perhaps this is one of the reasons why our diets are mostly comprised of a certain type of food. We tend to omit a lot of healthy foods just because we do not like their taste. For instance, people who like meat-based dishes are prone to consume lesser amounts of fresh foods like vegetables and fruits. Similarly, there are a lot of people who do not like dairy products. These are typical examples of imbalanced diets. Our meals should ideally comprise of healthy amounts of proteins, carbohydrates, minerals, vitamins, good fats and water. Thus it is important to explore new tastes and foods in order to include all the essential components of a balanced diet. Fast food like deep fried chicken or fish or potatoes, are richer in calories but low in nutritional value. We need to adapt our bodies slowly to a healthy lifestyle because it is not easy to curb our cravings for our favorite fast food. Alternately, we can also make some healthy changes to the ways our food is normally cooked. Our recipes can be made healthier if we reduce the number of fats and sugar in our everyday meals. Opting to grill or stir fry our meat and vegetables can greatly reduce our caloric intake and retain their nutrition. Eating fresh food is healthier than eating preserved, canned or processed food. This is because preserved food contains certain additives that may be unhealthy. Moreover, preserved foods are high in sugar or salt, which is also not healthy. It is indeed tempting to buy a can of peeled and diced fruits or vegetables rather than purchasing fresh fruit and vegetables and going through the trouble of washing and  peeling them.  

Change Management Research Paper Example | Topics and Well Written Essays - 1500 words

Change Management - Research Paper Example It has its extensive presence in every domain of the society. In the context of modern day business scenario, change is an important part of operational process of the companies irrespective of the industry that they are operating in. In the healthcare sector, with the increased level of business market competition and altering nature of customer demands, change has become quite crucial by a certain degree. However, it cannot be ignored that there exist a proper process of change management, which helps in building a systematic framework and enabling proper implementation of the change proposed (Reiss, 2012). Contextually, this paper will work towards initiating change in a particular healthcare organization, which will comprise analyzing the need for change and the strategies for making that change successful. Identification of Change and Why Identifying the change, which is to be undertaken, is quite vital with regard to build a systematic process for the same. It can be stated tha t the change will be suggested with analyzing the clinical environment of a particular healthcare unit. ... ealthcare unit is observed to be below standards in conducting their certain operational activities in accordance with the norms along with the standards set for the overall industry. Observably, the healthcare unit is seen to be lacking in the practice of hand hygiene. According to the report of CHICA (2013), there are millions of people who often get infected from nosocomial infection due to having deficiency in this particular practice. Hand hygiene, in the healthcare sector provides certain guidelines to both healthcare patients and the professionals in the workplace, so that they mitigate with the rising problems arising from non-adherence to the same (Centers for Disease Control and Prevention, n.d.). In this regard, change such as implementation of Infection Prevention and Control Guidelines will be initiated in the healthcare unit. It provides certain strict guidelines with regard to maintain hand hygiene in the unit to ensure enhancement in the performance of the organizatio n (CHICA, 2013). The healthcare unit is also seen to be lacking in providing quality services to the patients. It has been apparently observed that the healthcare organization possesses the responsibility to serve people with utmost integrity and responsibility. However, in analyzing the particular healthcare unit, it has been noted that the satisfaction level of the customers acquiring services from this unit is quite low, which further is a serious threat for the well being of the patients and the performance of the unit altogether. Hence, in this regard, proper implementation of NAHQ based Code of Ethics and Standards of Practice will be initiated as a change in the operation of the healthcare unit, further making sure that the healthcare unit work totally in compliance with the

Legal Requirements of a Will Essay Example | Topics and Well Written Essays - 2250 words

Legal Requirements of a Will - Essay Example Having understood the meaning of the will, the next step in the process of formation of the will is to understand the requirements of creating the will which has to be legally binding in the Court of law. Following are the conditions which have to be fulfilled in order to have a legally binding Will: 1. The Will made by the Testator must be the final version of his Will. There shall be no will made by him before he finally signs the Will, if in case there is a Will previous to the final Will then that Will shall be terminated and duly notified in the existence of the new and the final draft. 2. The Will shall be signed by the Testator 3. The Will shall have two witnesses at the least, and the witness’s shall have no inheritance of the assets in the structure of the Will, as they are supposed to be independent people who have no interest coming out from the creation of the Will. The Will should be signed by them. 4. The Testator has to be of sound mind and should be above 18 years of age. 5. The Testator should have an executer to execute the Will in the favour of the beneficiaries after his death, since the executer is the one who is responsible for the execution of the Will and making sure that the beneficiaries get their due share in accordance to the Will. 6. The Testator has to clearly identify the inheritors of his will and has to account for his property in full valuation.

Explain this Confucian Virtue and discuss the ways in which this does Essay

Explain this Confucian Virtue and discuss the ways in which this does or does not exist in contemporary American society. Use concrete examples. Make sure that you adequately define this Virtue - Essay Example Thus, the core of the teachings of Confucius oscillated around the right individual ethics, values and virtues that are morally healthy and socially upright. Confucianism refers to an ethical, virtuous, moral and as well as psychological system of thought that was introduced by Confucius (Sun, 37). This system borrows its origin from the periods of Autumn and Spring in the Han Dynasty. During that period, Confucianism was majorly used as a tool for ethical and sociopolitical teaching. The teachings of Confucianism majorly revolve around humanism. Such teachings mostly espouse the importance of family relationships and disregards beliefs in gods. The teachings further depict that human beings can be taught through personal as well as communal endeavors. In addition, the teachings of Confucianism maintain that individuals are improvable as well as perfectible relevant to their personal as well as communal endeavors (Smith and Huston, 51). This can be realized mainly through self-creation as well as self-cultivation of morally upright virtues alongside lending credence to ethical maintenance. Confucianism’s teachings majorly revolve around four main ethical concepts. These include ren, yi, li and zhi. Ren observes the virtue of humanness and altruism whereas yi obligates righteousness and moral responsibility to do good (Smith and Huston, 47). Li determines the way a person should conduct himself or herself with regards to certain norms. Zhi regards the ability to identify what is considered either wrong or right relevant to how an individual relates to others in the society (Wong, 67). It is of critical significance to acknowledge that the teachings of Confucianism can bring good results when incorporated within the governance policies and rules of any country. Confucius argues that for a leader to govern his subjects effectively, he must start with

South Korean Government vs. US Government Research Paper

South Korean Government vs. US Government - Research Paper Example The South Korean government and the U.S. government differ in terms of its basic structure, the branches of the government, electoral system, and political parties; however, they are similar in terms of corruption allegations and violations of human rights; and that the solution to these is an independent judiciary and a rigid constitution. Review of Literature First Argument: Differences The South Korean and the United States governments differ in terms of their basic structure, as well as in the branches of the government, especially in the legislative and executive branches. Moreover, both governments follow different electoral systems and political parties. Basic Structure. The South Korean government is presidential in nature except for the cabinet, which is partly parliamentary in carrying out its tasks. Moreover, the South Korean government is a central government that oversees all affairs of the nation and declares everything and all the laws are uniform throughout the countr y. The United States government, on the other hand, is based on the principle of federalism, where power is shared between federal and state governments. This is also a system where the autonomy of every State is recognized by the people. Each state, however, submits to the U.S. Constitution and to federal law when there is a dispute. Legislative Branch. The South Korean legislative body is known as the National Assembly of South Korea. It has 299 members who represent the four political parties of South Korea. The South Korean National Assembly formulates laws and does many things that any other legislative body of any democratic government would usually do, such as regulate the armed forces and make decisions regarding the national budget proposed by the executive branch (Savada & Shaw, 1990). On the other hand, the legislative body of the United States government is known as the Congress, which represents mostly two political parties – the Democratic and the Republican par ties, as well as Independent members. The United States Congress is made up of the Senate and the House of Representatives. The Congress is authorized to create laws, levy and collect taxes, issue patents, declare war and support the military, regulate military forces, create federal courts, establish infrastructures, and to regulate money. The United States Congress is made up of 435 members of the House of Representatives, representing every congressional district, each member serving two-year terms, and without any limit as to the number of terms its members may serve. The other component, the Senate, is made up of 100 members, two from each state, each serving six-year terms, without term limits. The role of the Senate is to approve Presidential appointments and to jointly approve bills with the Congress (Wilson & Dilulio, 2011). Executive Branch. The head of the South Korean executive branch is a president that is directly elected through national elections. The President serve s only one five-term year. The President is also the head of state and government as well as the commander-in-chief of the military. Just like many presidents of democratic countries, the South Korean President can declare a state of martial law, a state of emergency, or a state of war. He can also propose laws

Co-Benefits Analysis of Air Pollution and GHG Emissions for Hyderabad Essay Example for Free

Co-Benefits Analysis of Air Pollution and GHG Emissions for Hyderabad Essay In-country research teams, guided by policymakers and assisted by USA counterparts, identify key policy objectives and a range of conventional and innovative policy measures. The team analyzes the potential co-benefits of selected mitigation strategies and makes recommendations that inform policy decisions. Co-benefits analysis, outlined in Figure have primarily focused on estimating the human health benefits resulting from air quality improvements associated with increased use of clean energy technologies and measures. IES analysis could be extended to quantify additional benefits, such as economic development impacts (e. g. , job creation, trade balance) and reduced traffic congestion.

Oral Fast Disintegrating Anti-allergic Film Using Hot-melt

Oral Fast Disintegrating Anti-allergic Film Using Hot-melt Development and Evaluation of an Oral Fast Disintegrating Anti-allergic Film Using Hot-melt Extrusion Technology Manjeet B. Pimparade1, Anh Vo1, Abhijeet S. Maurya1, Joseph T. Morott1, Xin Feng1, Dong Wuk Kim1, Vijay I. Kulkarni1, Roshan Tiwari1, K. Vanaja2, Reena. Murthy2, H. N. Shivakumar2, D. Neupane3, S. R. Mishra3, S. N. Murthy1, Michael. A. Repka1,4* 1Department of Pharmaceutics Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS, USA 2Institute for Drug Delivery and Biomedical Research, Bangalore, India 3Department of Physics, University of Memphis, Memphis, TN, USA 4Pii Center for Pharmaceutical Technology, The University of Mississippi, University, MS, USA *Address for correspondence: Michael A. Repka, D.D.S., Ph.D. Professor and Chair, Department of Pharmaceutics and Drug Delivery Director, Pii Center for Pharmaceutical Technology School of Pharmacy The University of Mississippi, University, MS 38677 Abstract The main objective of this novel study was to develop chlorpheniramine maleate orally disintegrating films (ODF) using hot-melt extrusion technology and evaluate the characteristics of the formulation using in vitro and in vivo methods. Modified starch with glycerol was used as a polymer matrix for melt extrusion. Sweetening and saliva-simulating agents were incorporated to improve palatability and lower the disintegration time of film formulations. A standard screw configuration was applied, and the last zone of the barrel was opened to discharge water vapors, which helped to manufacture non-sticky, clear, and uniform films. The film formulations demonstrated rapid disintegration times (6-11 s) and more than 95% dissolution in 5 min. In addition, the films had characteristic mechanical properties that were helpful in handling and storage. An animal model was employed to determine the taste masking of melt-extruded films. The lead film formulation was subjected to a human panel for e valuation of extent of taste masking and disintegration. Keyword: Hot-melt extrusion, Orally disintegrating film, Taste-masking, Pediatric and geriatric, Modified starch, Human panel taste evaluation, Continuous manufacturing, Chlorpheniramine maleate Introduction It is estimated that 26-50% of the patient population find difficulty in swallowing tablets and hard gelatin capsules [1]. These patients mainly include the elderly who have difficulty taking conventional oral dosage forms because of hand tremors and dysphagia, and pediatric patients who are often fearful of taking solid oral dosage forms owing to their underdeveloped muscular and nervous systems [2]. In addition, patients who are mentally ill, developmentally disabled, uncooperative, on reduced liquid-intake plans or nauseated, and travelers who may not have access to clean water also are candidates for ODFs [3, 4]. The traditional alternative to swallowing difficulties is formulating a drug substance in liquid dosage form. However, liquid dosage forms have several limitations, such as the need for measuring, bulkiness, physical, chemical, and microbial stability issues, spoilage, inaccurate dosing, and organoleptic properties of drug and drug formulations [5]. Conventional solid oral formulations contributed significantly to minimizing the shortcomings of liquid dosage forms. The crushing of tablets or opening of capsules is a straightforward way for patients or caregivers to lessen the swallowing difficulties. However, serious consequences may be associated with modified-release, enteric-coated, and cytotoxic or hormonal medicines, as these formulations are designed for special cases [6]. Moreover, European Medical Agency does not recommend the splitting or crushing of tablets because the active pharmaceutical ingredient (API) is not evenly distributed in the tablet [7, 8]. Thus, it is very convenient to develop a formulation that disintegrates in the oral cavity and eases the swallowing process. In recent years, fast disintegrating oral formulations established their importance in patient population suffering from dysphagia, stroke, thyroid disorder, Parkinsons disease, multiple sclerosis, and cerebral palsy [9]. Commercially available orodispersible tablets (ODT) and orodispersible films (ODF) are the most successful platforms for pharmaceutical product development. ODTs are solid oral dosage forms that disintegrate rapidly, typically within 30 s, with or without the administration of additional water [10]. They provided great comfort to patients with swallowing difficulties [11]. Despite the benefits of ODTs, there are some challenges in their processing and handling owing to their fragility and brittleness, which warrant special package for protection during storage and transportation [12]. The films are flexible and not as fragile as most ODTs. Hence, there is ease in transportation, consumer handling, and storage of ODFs. ODF can be defined as a dosage form that employs a water-soluble polymer (generally a hydrocolloid, which may be a bioadhesive polymer), which allows the dosage form to quickly wet, adhere, and dissolve to release the drug when placed on the tongue or in the oral cavity [5]. ODF alleviated patient discomforts associated with swallowing disabilities without compromising the therapeutic effect. In addition, it could ease the administration of drugs to pediatric patient population [13]. Moreover, ODF can be helpful in curtailing dose variations in younger patients, in whom liquid formulations are the most accepted way of drug delivery. Currently, solvent casting methods are commonly employed to produce ODFs, owing to its ease of production and low set up costs [14, 15]. Despite its wide application, products with batch-to-batch variation may be produced because of multiple steps involved in the production. In addition, air entrapment in the films is commonly observed in solvent casting methods, which leads to dose variations and inappropriate esthetic appearance of the product [15]. The use of large amounts of solvent is one of the biggest shortcomings of this method as solvent removal and disposal is a long and tedious process. Thus, it is very beneficial to develop a solvent-free, quick, and continuous process that could diminish the shortcomings of the current manufacturing method. Hot melt extrusion (HME) is a one-step, solvent-free continuous manufacturing process, which established itself in the pharmaceutical arena for the development of various solid oral formulations [16-25]. This technology involves the use of temperature and shear to process polymer blends and extrude them through a die of the desired design [26]. HME could be an effective alternative to the solvent casting method as it diminishes the inherent shortcomings, such as the use of solvents and problems involved in the mixing and drying steps. This ultimately makes HME process efficient and cost effective for patients [27, 28]. This study has three main objectives: to 1) develop a robust patient-friendly orally fast disintegrating film of chlorpheniramine maleate (CPM); 2) evaluate these formulations with different in vitro and in vivo techniques, and 3) demonstrate the feasibility of HME techniques for continuous manufacturing of ODF without the use of solvents. To the best of our knowledge, there is no published literature on the manufacturing of orally fast disintegrating formulations using HME technology and evaluation of films using in vitro and in vivo techniques. Materials and Methods 2.1. Materials CPM was purchased from MP Biomedicals, LLC (Solon, OH, USA). Lycoat RS 780 (modified starch) was supplied by Roquette America Inc. (Keokuk, IA, USA). Citric acid and glycerol were ordered from Fisher Scientific (Pittsburgh PA, USA). Magnasweet sample was gifted by Mafco worldwide LLC (Camden, NJ, USA). Sucralose was supplied by JK Sucralose Inc. (Edison, New Jersey, USA). 2.2. Thermal analysis Thermogravimetric analysis (TGA) studies (Perkin Elmer Pyris 1, Shelton, CT, USA) were performed to estimate the thermal stability of the API and excipients during HME processing. Data were analyzed using Pyris software. The API excipients were heated from 30-160à ¢Ã¢â‚¬Å¾Ã†â€™ at 20à ¢Ã¢â‚¬Å¾Ã†â€™ /min. 2.3. Material preparation and blending CPM, citric acid, and Lycoat RS 780 were dry mixed at amounts outlined in Table 1 using a V-shell blender (GlobePharma, Maxiblend, New Brunswick, NJ, USA) after passing through an ASTM #30 mesh. The plasticizer (glycerol with dissolved sucralose and Magnasweet) was incorporated slowly into a high-shear mixer (Model RSI 3VG, Robot Coupe Industrial Division, Ridgeland, MS, USA) containing the previously mixed blend with all excipients and allowed to blend for 10 min. 2.4. Hot melt extrusion The blends were melt-extruded using a co-rotating twin-screw extruder (16 mm Prism EuroLab, ThermoFisher Scientific, Pittsburgh, PA, USA) at 30-50 rpm over a temperature range of 100-  Ãƒâ€šÃ‚  Ãƒâ€šÃ‚  Ãƒâ€šÃ‚  Ãƒâ€šÃ‚  Ãƒâ€šÃ‚  Ãƒâ€šÃ‚  Ãƒâ€šÃ‚   110à ¢Ã¢â‚¬Å¾Ã†â€™. A degassing port was introduced in the last zone of the barrel to release excess water vapor, which would otherwise produce unwanted bubbles in the films. Additionally, the film die was installed with preset thickness. The physical blend of the formulation was manually fed into the hopper, and the films were collected, wrapped in wax paper, sealed, and stored in polyethylene bags at 25à ¢Ã¢â‚¬Å¾Ã†â€™ with 40% relative humidity. 2.5. Film characterizations 2.5.1 Film thickness and mechanical properties The mechanical properties of the films were evaluated using the TA.XTPlus texture analyzer equipped with 5 kg load cell (Texture Technologies, Scarsdale, NY, USA). The films were cut into dumbbell shaped specimens with a width and length of 1.55 and 15.5 mm, respectively, and placed longitudinally in tensile grip probe on the texture analyzer. The films were tested at a crosshead speed of 2 mm/min and held between two clamps positioned at 5 mm. The results of film samples that broke at and not between the clamps were not included in the calculations. Each film formulation was measured with ten replicates [29]. The tensile strength (Ts) and percent elongation (%E) were calculated using the results from texture analyzer. Film thickness was measured using an electronic caliper (Fisher Scientific, Pittsburgh, PA, USA) at different positions. 2.5.2 Disintegration test The film was cut into an appropriate size as per the dose (4 mg) and placed in a petri dish. Then, 100  µL artificial salivary media was added, and the time for complete disintegration of the film was recorded (n =10). 2.5.3 Surface pH of film The film was moistened using 5  µL water and a contact electrode touched the surface of the film (Oaktonà ¢Ã¢â‚¬Å¾Ã‚ ¢ pH meter, Fisher Scientific, Pittsburgh, PA, USA), followed by pH measurement (n=6) 2.6. Analytical method A Waters high performance liquid chromatography (HPLC) system equipped with a Water 600 binary pump, Waters 2489 UV/detector, and Waters ® 717 plus autosampler (Waters Technologies Corporation, Milford, MA, USA), and a Phenomenex Luna 5  µm C18 (2) 250 x 4.6 mm column (Torrance, CA, USA) were used at a detection wavelength of 254 nm. The mobile phase consisted of 7.5 mM monobasic potassium phosphate in methanol and water at a ratio of 62.5:37.5 (v/v). The mobile phase flow rate was maintained at 1.0 mL/min, and an injection volume of 10 ÃŽÂ ¼L was used [30]. HPLC data were analyzed using Empower 2 software (Milford, MA, USA). 2.7. In vitro dissolution studies The films for dissolution studies were cut into sizes relative to the dose of CPM (4 mg). The drug profile was evaluated using a USP dissolution apparatus-I (Hanson SR8, Chatsworth, CA) maintained at 37  ± 0.5à ¢Ã¢â‚¬Å¾Ã†â€™ and having a shaft rotation speed of 100 rpm. The dissolution test was performed using 900 mL phosphate buffer (pH 6.8). The samples were withdrawn at 5, 10, and 30 min and analyzed using the HPLC- UV system. 2.8. X-ray diffraction studies (XRD) X-Ray diffraction (Bruker D8 Advance, Madison, MI, USA) was used to determine the physical state of the drug, excipients, and film formulations. The X-ray diffraction apparatus used CuK radiation at 40 mA, 40 kV, a scanning speed of 2à ¢- ¦/min, and diffraction angle (2ÃŽÂ ¸) range of 5-55. 2.9. Scanning electron Microscope (SEM) The surface morphology of the films was evaluated using SEM analysis. The samples were mounted on adhesive carbon pads placed on aluminum and sputter coated with gold using a Hummer sputtering system (Anatech Ltd, Springfield, VA, USA) in a high vacuum evaporator. A JEOL JSM-5600 SEM operating at an accelerating voltage of 10 kV was used for imaging. 2.10. In vivo taste evaluation Twenty-one naÃÆ' ¯ve adult male Sprague-Dawley rats (175-200 g) were ordered from Harlan Laboratories (Houston, TX, USA) for the study. The rats were housed in Plexiglass cages with Corncob bedding in a vivarium that maintained a 12 h light/dark cycle and an ambient temperature of ~22à ¢Ã¢â‚¬Å¾Ã†â€™. Food and water were available without any restriction, except during the training and taste evaluation experiments as mentioned below (2.10.1). All procedures were approved by the Institutional Animal Care and Use Committee (IACUC) at The University of Mississippi, University, USA (protocol no. 15-026). This study was performed as per the procedure in our previous publication on taste assessment method for bitter drugs [31]. 2.10.1. Training paradigm The rats were trained for licking behavior (response to thirst) by depriving them of water for 22 h, but they had ad libitum access to food. After the water deprivation period, the Plexiglass cage was divided using plastic transparent dividers to provide an individual water bottle to each animal. Eventually, the rats were provided with graduated water bottle for 30 min, and the amount consumed at 15 and 30 min were recorded. This training paradigm was performed for 2 days before the taste evaluation experiment. 2.10.2. Evaluation of bitterness sensitivity of rats To determine the concentration of CPM for this study, a sensitivity test for bitterness was performed in rats. After depriving the rats of water for 22 h, sensitivity toward 0.5 mg/mL CPM solution was evaluated on the first day, followed by a washout period of 24 h. Subsequently, the effect of 1 mg/mL CPM solution was examined, and the results were recorded. 2.10.3. Experiment The experiment was performed for 30 min with 30 mL test formulation following the 22 h water deprivation period. After each experiment, the rats had a washout period of 24 h to avoid any memory of the taste of the previous formulation. The rats had ad libitum access to food during the experiment and washout period. The amount of solution remaining at 15 and 30 min was noted and subtracted from the original test volume. Varying results caused by spilling of the test solution while measuring or leaking of bottle knob were omitted from the study. Notably, animal behavior responses such as jaw smacking, oral grooming, and retreating were observed, which was not the focus of this study. Formulations N2, N7, and N9 at 0.5 mg/mL CPM were used for bitterness evaluation study in rat model. The average amount of solution consumed by all animals was calculated and expressed as the mean standard deviation. The mean scores between the physical mixture and formulation were compared using a student t-test at 95% confidence level and P 2.11. Film evaluation by human panel The evaluation of film for palatability, disintegration time (DT), and organoleptic characteristics was performed at the Institute for Drug Delivery and Biomedical Research, Bangalore India (Protocol number VIPS/2013/12). The subjects were recruited after obtaining informed consent. This study is also in accordance with the Code of Ethics of the World Medical Association (Declaration of Helsinki). The experimental procedure for this study was as per our previously published work [10, 32]. 2.11.1. Human subject selection criteria Six human subjects belonging to either sex were recruited. They were asked to abstain from coffee/tea and other beverages for 12 h. The subjects were allowed to drink only water for 12 h. Moreover, they were asked not to eat chocolates or other candies for over 6 h. The inclusion criterion was healthy human subjects aged 18-42 years, and the exclusion criteria were subjects suffering from fever, mouth ulcers, dry mouth, cold, nose block, and wounds as well as smokers.   2.11.2. Data collection Before data collection, the subjects were asked to wash their mouth with water at ambient temperature. The surface temperature of the tongue was recorded using an infrared (IR) thermometer, and a difference of  ±5à ¢Ã¢â‚¬Å¾Ã†â€™ relative to the body temperature was considered an exclusion criteria. 2.11.2.1. Bitterness perception The subjects were asked to taste aqueous solutions of CPM, beginning with very dilute solutions and progressing to higher concentrations, by placing 2 mL solution for 30 s on the tongue/buccal cavity. The concentrations screened were 0, 0.5, 1, 2.5, and 4 mg. The volunteers were asked to report the perception each time: 1- I feel bitter taste, 2- I feel something but cannot identify the taste, and 3-I do not feel the taste. The subjects who reported 2 or 3 were asked to taste higher concentrations of the solution until they expressed perception 1. This was recorded as the threshold for an individual. For individuals who reported a score of 1, at least 1/5th the drug concentration of the actual dose was only allowed for testing the products. A few high concentration API solutions above the individuals perception threshold were made for tasting, and the subjects were subsequently asked to provide a score for each solution (Table 3). The highest concentration of the solution contained C PM equivalent to the dose present in the products tested. The scoring pattern followed was according to modified hedonic scale: 0-no taste, 1- taste something (threshold), 2-slightly bitter, 3-moderately bitter, 4-bitter, and 5-strongly bitter. 2.11.2.2. Formulation evaluation and data analysis A washout interval of 12-24 h was allowed after screening the standard solution. The individuals were asked to taste the products (physical mixture or ODF) randomly (blinded) and score the product. The products were placed on the tongue/buccal cavity for 30-40 s, and the subjects were asked to score the bitterness on a scale of 0-5 for each product. Moreover, volunteers were asked to report the time for complete disintegration of the film. Sufficient washout time was allowed between the products, and the volunteers were allowed to drink copious amounts of water after tasting each product. The average of the scores given by all individuals were taken and expressed as the mean standard deviation. The mean scores between the physical mixture and formulation were compared using a student t-test at 95% confidence level, and P Results and Discussion 3.1. Preparation of hot-melt extruded film Modified starch is very difficult to extrude because of its high glass transition temperature. Thus, there is a need to introduce a plasticizer during extrusion, which could reduce the melt viscosity and increase the free volume of starch chains. For this study, glycerin was used as a plasticizer in different proportions, and it exhibited excellent extrudability with significantly lower torque (4.8-7.2 Nm) values than typically encountered. The barrel design was modified with a degassing port to remove excess amount of water vapor from the molten mass. Initial studies without a degassing port demonstrated the presence of bubbles as well as unequal distribution of drug in the film samples. Standard screw configuration (Figure 1) with three mixing zones was utilized for this study. It provided enough shear for dispersive and distributive mixing of the drug and helped get excellent content uniformity in all the extruded film formulations. The extruded films were stretched using the roll connected to the extruder assembly. This aided in making thin films with uniform thickness, and the roll speed was optimized for steady collection of the film. The combination of processing and formulation parameters helped to manufacture uniform, clear, and very thin films (60-110  µm) using melt extruder. 3.2. Physiochemical evaluation of films TGA is very critical before performing HME because the drug and excipients are exposed to high temperature during the extrusion process, and there are possibilities of drug degradation or thermally-induced chemical reactions or both [16]. The TGA results (Figure 2) specified that API, polymer, and excipients were chemically stable in the HME processing temperature range. Lycoat RS 780 demonstrated a loss of weight (33]. XRD was used to investigate the physical state of the drug after HME process. The XRD results (Figure 3a 3b) of CPM illustrated prominent peaks at 2ÃŽÂ ¸ angles of approximately 13, 19, and 20 degrees, while citric acid showed peaks at 2ÃŽÂ ¸ angles of 18, 19, and 26. The melt-extruded formulation did not show any peak that confirmed the presence of drug in an amorphous form. The reasons behind the complete conversion of drug to an amorphous form were the high shear during extrusion, low drug load, and relatively high amounts of glycerin. The presence of CPM and excipients in an amorphous form aided the flexibility and clear appearance of the film. 3.3. Dissolution studies Lycoat RS 780 is a comparatively new modified starch-based polymer, which demonstrated its significance in film coating for tablets and oral film development using solvent casting method [34, 35]. Being a non-gelling and highly water-soluble polymer, it provides rapid disintegration and dissolution to formulations. Visual inspection during dissolution demonstrated rapid disintegration of the film when it touched the dissolution media. This characteristic helps in the rapid onset of action of the formulation, because the drug can diffuse from the oral mucosa and reach the systemic circulation [36]. During dissolution studies, the formulations rapidly release CPM, and it was attributed to hydrophilic excipients and Biopharmaceutics Classification System (BCS) class I drug. These films had very low thickness (60-110  µm) and higher surface area, which enabled interaction with dissolution media and rapid disintegration following complete dissolution. Dissolution results (Figure 4a 4b) showed ~95% drug release in the first 5 min of the dissolution experiment, and at 10-min time points, there was complete release of the drug. 3.4. SEM evaluation The surface morphology was examined by SEM for all film formulations. SEM images did not exhibit CPM crystals, indicating an amorphous nature of drug in formulations (Figure 5). The formulations showed very smooth surface at low magnification. This affirmed the smooth texture of film surface, which is one of the esthetic attributes of films. However, at microscopic level, there was high surface area, which helped in the rapid disintegration of the film. 3.5. Film characterizations As illustrated in Table 2, the film formulations demonstrated excellent D.T of 6-11 s, which was attributed to the thickness of the film and presence of water-soluble materials in the film. The formulations contained water-soluble excipients and APIs such as CPM, citric acid, glycerin, and modified starch. The most crucial parameter for disintegration is the low thickness of the film. As the films had a thickness range of 60-110  µm, they aided in the faster disintegration of all film formulations. In addition to the low thickness of the film, the amount of saliva in the oral cavity is very critical for rapid disintegration. The normal flow of saliva in a healthy person is 0.34 mL/min, and it can be increased by the addition of agents that simulate salivary production, including citric, malic, lactic, ascorbic, and tartaric acids [14]. Citric acid is the most preferred saliva-stimulating agent, and it was estimated that citric acid could increase salivary flow approximately 5- fold in 2-6% proportion in the formulation [14]. With the addition of citric acid, the pH of the films was found to be in the range of 2.9-3.4 and it could contribute in improving rate of salivary flow after administration of formulation which will aid in rapid disintegration of film product. All the film formulations were tested for their Ts and %E (Table 2). Ideally, the film should have desirable mechanical properties so that it can remain intact during handling and transport. ODFs showed appropriate strength and %E. These excellent mechanical properties were attributed to the presence of glycerol, citric acid, and CPM, which reduced film stiffness via disruption of intermolecular forces of the polymer owing to the accommodation of these compounds between the strands, thereby providing elasticity to the films [37, 38]. 3.6. In vivo taste evolution Firstly, the taste perception of rats was evaluated by administering 0.5 and 1 mg/mL CPM dissolved in distilled water. These results were important to avoid taste variability between animals (Figure 6), and showed that the rats consumed ~10 and ~14 mL of water in 15 and 30 min, respectively. The results of this study were comparable with those of the study published by Tiwari et.al. Thus, the rate and extent of consumption of water were reduced significantly to ~3 and ~5 mL in 15 and 30 min with the administration of 0.5 mg/mL CPM solution. At a higher concentration of 1 mg/mL, there was notable reduction in consumption of water to ~1.6 and ~2 mL at 15 and 30 min. Notably, this reduction in consumption of CPM solution despite deprivation of water for 22 h affirmed an aversion toward CPM. Moreover, aversion behaviors (Figure 7), such as jaw smacking, oral grooming, nose wrinkle, paw wipe, forelimb flail, head shake, paw shakes, and retreating confirmed the dislike of rats toward the d rug solution [39]. As illustrated in Figure 6, the rats consumed ~10 and 12.5 mL of N 2 solution (5% CPM in the film) in the first 15 and 30 min, and the amount was comparable with the consumption of water. In addition, N7 (10% CPM) exhibited consumption of ~ 4.7 and ~8 mL at 15 and 30 min. Furthermore, N9 (7.5% CPM) showed consumption of ~6.3 and 10 mL at 15- and 30-min time point. These results indicated that with increasing concentrations of CPM, there was noticeable reduction in the consumption of formulation. The rats did not show aversion behavior such as forelimb flail with N2 formulation. However, there was a surge in the aversion behavior response upon increasing the drug concentrations in N7 and N9,. The results of this study were very helpful to understand about the taste of pure drug and formulation. It provided an insight into the taste of products, which helped to screen this formulation for human studies. 3.7. Film evaluation by human panel Before evaluation of taste of the formulation, it is very important to understand the taste perception of human volunteers to minimize intra-subject variability. Taste perception study was performed on six healthy human volunteers. Initially, different concentrations of CPM in 2 mL of water were administered to the human subjects. Three subjects had threshold at 0.5 mg and the remaining three subjects reported moderate bitterness at the same concentration. A dose of 2.5 mg demonstrated bitterness in all subjects, and only three volunteers could taste higher concentration of CPM (4 mg, Table 3). This initial evaluation confirmed the appropriateness of the subjects for taste masking study. The results of taste masking evaluation in animal model suggested that formulation N2 with 5% CPM had significant taste masking. Moreover, this formulation had an excellent D.T (7 s) in in vitro studies. Based on t