Employment relations Essay Example | Topics and Well Written Essays - 2250 words - 1

Employment relations - Essay Example Trade unions are institutions which are constituted for the welfare and protection of employees. Such unions are needed to first identify the major issues faced by the workers and then they should work to find remedies for those problems. Women and minority groups have demands for transformation of unions so that unions incorporate their current issues and raise voice for them. Trade unions or labor unions are special organizations formed by individuals that represent people at work to strengthen the protection of their existing rights, and to raise their voice against any uncivil act. It is also constituted as the union’s duty to protect and improve upon the payment and working conditions of the employees. In addition to that, the unions also campaign for laws and policies for the betterment of the working population. The ideology of union formation is basically rooted in the concept that an individual worker has very little power to influence decisions that are made about hi s or her job. Hence, in order to make the workers have more control of their working conditions, the unions attempt to join them all together so that there is more chance of them having a voice (Sofia-Roth, I. 2010, p.3). Labor unions are criticized in many aspects like the ineffectiveness of their existence, raising unnecessary aggression against employers, provoking employees for unjustified demands and so on. Research has been conducted about the usability of unions and their impacts in addition to checking out the argument that unions have outlived their existence. The global environment, the diversity in the workforce, decentralized structures, flattened organizations and increased employee autonomy suggest that unions are no more required. On the other hand, the cases of labor injustices and uncivil practices are still in practice. Employees still have to face the challenge of getting justifiable wages for their skill and effort, suitable working conditions and social benefits . Therefore, it can be easily assumed that labor unions are still required and are needed to play an effective role in setting up standards and regulations fro working class. Although the unions have not become obsolete altogether, yet they require transformation and modification in many ways. Due to globalization, technological advancements and diverse, multicultural workforce the role of unions should be improved and modified according to new requirements. They need to work on building their image as organizations supportive to both the employees and employers, rather than being taken as bodies with their main focus being on strikes and riots. Women and ethnic minority groups are always being discriminated and undervalued since their introduction into employee market. Even their introduction and entry into the workforce is an issue to be considered in this modern and civilized world. These issues require consideration from legislative bodies, labor rights institutions, social welf are groups, non governmental organizations and the most relevant institution that is ‘the union’. Unions need transformation to adjust and accommodate the needs of women and minority groups in an effective way. It can be done by taking into consideration all those issues which are currently being faced by the members of minority groups and then making policies and strategies to process these issues along with the general labor policies. Although the issue is been discussed and resolved in many ways until now, but its complexity suggests that it requires further consideration in various dimensions and by different institutions. To start with the unions, they must recruit the women and minority group members. It will give a moral support and deeper penetration into the problem to be solved. When the union involves such individuals, only then they can argue that they are working in the best interests of all the stakeholders. Furthermore, it will erase the unnecessary

Balancing Life and Responsibility Research Paper

Balancing Life and Responsibility - Research Paper Example The project involved operations in different locations. While operations within the office majorly required office work, field operations were more involving and subjected team members and their supervisor to adverse conditions such as cold weather and dust. It was therefore equitable to alternate team members between office and the field for a fair experience. My two project supervisors were therefore expected to alternate but one of them reported allergic reactions that could not allow her to work in the field under the then conditions. The other supervisor equally needed a break from the field as members of his team were accorded. This created a dilemma because while each of the supervisors’ needs was justified, I did not have extra personnel to supervise the field apart from the two. I therefore had the option of compelling the allergic supervisor to honor her contractual obligations and go to the field or to protect her life by compelling the other supervisor to work in t he field since that was still part of his contractual obligation (Badaracco, 1998). I applied a directive approach of situational leadership to resolve the dilemma (Blanchard, 2008). I balance my professional identity and personal identity by avoiding conflict of interest in my professional scope of work and avoiding personal attachments to involved processes. This is because personal identity involves personal traits with emotional attachments and a conflict with professional identity may undermine decision-making and compromise professional roles. I therefore ensure a balance between the two identities by being emotionally sober and ensuring that I identify organization’s interest and policies in every decision (Badaracco, 1998). Professional identity and personal identity are different in their scope of development and application. Personal identity is derived from social setups and experiences and majorly applies to family setups and informal

Frist assay in helth an safety management Essay

Frist assay in helth an safety management - Essay Example It includes both large scale civic surroundings i.e. places of work, as well as personal places such as homes. The phrase, today, has been widely known and used to illustrate the interdisciplinary field of study which seeks to address various aspects of man – made surrounding such as its design, management, and safety issues in relation to human activities. The construction industry has a disturbingly low safety mechanism as compared to the other industries where accidents which involves temporary access systems, fitting of defective components, unauthorized modification of structures, omission of barriers as well as other more common factors arising on account of management failure such as failure to control and prevent risk, unsafe methods and practices, and inadequate training and supervision account for a large proportion of injuries in the construction industry worldwide1. Although the construction industry has been widely appreciated for making major contributions in accelerating development across the globe, its image has been tarnished by the number of accidents and health hazards that occur on an almost regular basis on the sites. This research paper deals with the various aspects involved in the workplace safety management practices with regard to the construction industry. It analyses and discusses the contemporary issues, current trends and strategies that could be used to improve the working conditions and reduce the health hazards which are faced by construction workers. According to HSE approximately 2.2 million3 people work in Britain’s construction industry, which is incidentally considered to be one of the most dangerous places to work, making it one of the largest industries in the country. Statistics suggest that nearly 2800 people have died as a result of accidents on construction sites in the past 25 years4. Most of the accidents occurring on

HRM 'Managing Human Resources' Assignment Example | Topics and Well Written Essays - 1750 words

HRM 'Managing Human Resources' - Assignment Example The HRM function is of particular importance in the post-industrial economy (Harris, 2003) In this emerging system, the critical factor in production has shifted from machines and equipment to the "knowledge" worker (Marchington, 2002). That is, service has replaced production as the driving force in the economy, and the prominent way value is added is through the expertise of knowledge workers and the ministrations of service providers. In systems like this, it becomes even more important to obtain and use the full talents of all employees in the organization. Thus, the skilful adoption and use of HRM policies becomes a significant lever through which to move and direct the performance of the organization. As Gibb (2000) noted, HRM is really a series of policy choices about how employees are to be treated, paid, and worked. These policies will in turn impact and condition the nature of the employment relationship. Different policies lead to different outcomes in employee commitment, competence, and congruence with organizational goals. Likewise, each policy choice presents the decision maker with a distinctive cost and benefit alternative. For example, compensation policy choices to pay either at the low, average, or high end of the labour market have rather dramatic implications for employee commitment to the organization and for costs to the employer. The fundamental rationale for effective management of human resources should be to identify and implement those policies, programs, and procedures that will yield the desired levels of loyalty, skill, and direction in the most cost-effective manner possible. In this sense, HRM offers to organizational decision makers a set of people in vestment opportunities. Managing human resources effectively has never been as important as it is today and will be tomorrow. In today's service economy of knowledge-based, high-discretion jobs, the commitment and competence of employees can spell the difference between those organizations that win and those that are merely in the race. Establishing policies, programs, and practices that produce these results on a cost-effective basis and comply with laws and regulations is a complex undertaking. HRM can and should play a strategic role in the management of the organization. According to Chandy (2001), a large number of organizations have encountered severe difficulties finding personnel in recent years. We have little knowledge about how organizations are coping with these difficulties and are going about hiring staff. Considering the supply/demand trends of the last few decades - when the labour market used to be a buyers' market and a considerable pool of unemployed formed a buffer that could absorb cyclic fluctuations in labour demand - it is almost not astounding that most studies focused on employees' job seeking activities. (Chandy, 2001, pp 403-405) Research on the theoretical and empirical facet of organizations' behaviour to find appropriate staff, has studied first and foremost the selection behaviour: how to select personnel from a group of applicants. Nearly all vacancies are filled from a group of applicants that is created soon after posting the vacancy. On account of the economic expansion of the first

The culture of an international non-profit organisation Essay

The culture of an international non-profit organisation - Essay Example This essay using the cultural web analyzes the culture of a non-profit (referred to here as Company X). Company X is a not-for-profit organisation founded in 1981 in the United States as a charity aimed at improving the lives of children and families. Over its 20 years the company’s mission has narrowed to or become more specific targeting early childhood care and education, children’s rights and grassroots community development. Company X is currently headquartered in California in the United States but has a presence in five continents as follows: Africa – Kenya, Zimbabwe and Ghana; Asia – India and Nepal; Europe – Norway, South America – Chile and North America – the U.S. Company X primarily obtains its operating resources from individual and corporate donations predominantly from within the US. To supplement this funding, Company X owns and runs two exclusive pre-schools in California that boast of an enviable waitlist as well as f our other high cost pre-schools in the same state. Over and above this, the non-profit has offered and continues to offer consultancy services on early childhood care and education at very competitive rates to other non-profits, for-profit corporations and even governments such as the government of Singapore, Ecuador and even the state of California as another source of funding. The local chapters in Africa and Asia have wholly been dependent on obtaining slices of the US funding â€Å"pie† to sustain their programs. ... To supplement this funding, Company X owns and runs two exclusive pre-schools in California that boast of an enviable waitlist as well as four other high cost pre-schools in the same state. Over and above this, the non-profit has offered and continues to offer consultancy services on early childhood care and education at very competitive rates to other non-profits, for-profit corporations and even governments such as the government of Singapore, Ecuador and even the state of California as another source of funding. The local chapters in Africa and Asia have wholly been dependent on obtaining slices of the US funding â€Å"pie† to sustain their programs. However, with the global recession of 2008 hitting the US funding base, Company X has been pushing for heads of its global chapters to source for local funding to sustain their programs. Company X has been implementing this slowly over the last three years through activities such as the following. First it has instituted greate r controls, monitoring and reporting over all funds disbursed. Then it demanded that each chapter develop their own five year strategic plan which will show how they will increasingly source their own funding. Thirdly, from 2009 Company X reduced its funding by 10 to 15 per cent depending on their projections over which local chapters had better odds of fundraising depending on the economic condition of that host country. The problem though is that to date none has successfully fundraised. With the economies of Europe and America, poor for the former and sluggish for the latter, the typical donors that Company X relied on have tightened their purses as they cautiously weigh their own investments. This coupled with the rising economies of

Persuasive- Pro Gay Marriage Essay Example for Free

Persuasive- Pro Gay Marriage Essay The legalization of same-sex marriage benefits both LGBT people and America as a nation. As states progressively begin to legalize same-sex marriage, it’s a convenient time to refocus attention on the many advantages associated with the pursuit and achievement of marriage equality. If same-sex marriages are legalized in Texas, not only will it benefit the state but also it will promote equality and non-discrimination in society, provide economic and business opportunities, and strengthen America’s national identity and international reputation. Millions of LGBT people contribute daily to American life in a multitude of ways culturally, socially, financially, politically, vocationally, and spiritually. They are vital to this nation’s continued growth and evolution and the U.S.A. would suffer greatly from the extraction of their many contributions. The legalization of same-sex marriage encourages the human right that everyone deserves. This promotion of equality and non-discrimination is extremely important in reducing homophobia and encouraging a minority group in society that has suffered colossal amounts of disgust that nobody deserves. â€Å"More than 1 in 5 LGBTQ students are physically harassed or assaulted because of their sexual orientation.† Children and young adults are being bullied because of whom they like; many of them cannot deal with this harassment and end up committing suicide. A large part of this nation’s future will be dead if this nonsense doesn’t quit. What more of a reason d o people need to know to see that homophobia is wicked and same-sex marriage should be permitted? It has been proven that same-sex marriage has provided a major economical boost to those states and countries that have embraced marriage equality. The marriage and wedding industry is a significant one. â€Å"Nearly $260 million was injected into the New York City economy in the year following the legalization of same-sex marriage.† Its obvious that money-obsessed geezers that are always looking for a way to get more money out of citizens run the government. They’d be absolutely blind and useless not to acknowledge that authorizing same-sex marriages could be a win-win for both them and gay couples. America has historically presented itself as a global leader in matters of freedom and democracy. It’s unfortunate and ironic, however, that  back on home soil one particular group of people is consistently denied full access to the â€Å"American dream.† The fact that the federal government doesn’t recognize same-sex marriage in a majority of the sta tes has damaged America’s international reputation in relation to LGBT rights. If people would stop discriminating and start embracing this way of life it would play a key role in enhancing America’s international reputation in matters of social justice and in restoring this nation’s integrity as a global leader in the competence of civil and human rights. Also, â€Å"Liberty and justice for all† would finally be believable when same-sex couples are granted equal access to laws across the country. It’s time for things to change and begin to celebrate diversity and difference in our society, rather than continuing to fear or attack it.

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