Colon Specific Drug Delivery

Colon Specific Drug Delivery ABSRACT The colon is a site where both local and systemic delivery of drugs can takes place. Colon specific drug delivery has achieved importance for the delivery of drugs for the treatment of local diseases associated with the colon like crohn’s disease, ulcerative colitis etc. as well as for the systemic delivery of proteins, therapeutic peptides, antiasthmatic drugs, antihypertensive drugs and antidiabetic agents. A drug need to be protected from degradation, release and absorption in the upper part of GIT and then to be ensured abrupt and controlled release in the proximal colon. This article reviews a detailed study about need of colon specific drug delivery, limitation and challenges, factors affecting colonic drug delivery, different approaches of colon including some successful novel approaches such as CODESTM, Pulsinicap system, Port system, Colal pred system, Multiparticulate system and also a study on evaluation for site specific drug delivery to colon. INTRODUCTION Drug administration through an oral route is the most convenient and important route of administering drugs for systemic effect. At about 50% of the drug delivery systems available in the market are oral drug delivery systems and these systems have more benefits due to patient acceptance and ease of administration. During the last decade considerable interest has been given in developing site-specific formulations for targeting drugs to the colon. Colon specific drug delivery has achieved increased importance not only for the delivery of the drugs for the treatment of local disorders associated with the colon like Crohn’s disease, ulcerative colitis, irritable bowel syndrome and constipation but also for the systemic delivery of proteins and peptides, antihypertensive drugs, antiasthmatic drugs and antidiabetic agents. The colon specific drug delivery system should have capability to protect the drug en route to the colon i.e. drug release and drug absorption should not occur in the stomach as well as the small intestine, and the bioactive agent should not be degraded in either of the dissolution sites but only released and absorbed once the system reaches the colon.1 Colon targeted drug delivery would additionally be valuable when a delay in absorption is desired from a therapeutically point of view in the treatment of diseases that have peak symptoms early in the morning, such as nocturnal asthma, angina or arthritis. The rapid advancement of biotechnology and genetic engineering resulted into availability of peptides and proteins at reasonable costs; there has been an increased interest in utilizing the colon as site for drug absorption. The potential candidates in this respect include analgesic peptides, oral vaccines, contraceptive peptides, growth hormone, insulin, erythropoietin, interferon, and interleukins (Saffran et al., 1988; Mackay and Tomlinson, 1993).2 The colon is a suitable absorption site for peptides and protein drugs due to: i) less diversity and intensity of digestive enzymes ii) less proteolytic activity of colon mucosa resulting in better prevention from hydrolysis and enzymatic degradation in duodenum and jejunum iii) increased systemic bioavailability iv) long colon residence time (5 days) and high responsiveness to absorption enhancers. There are number of methods or techniques through which colon drug targeting can be achieved, such as formation of prodrug, coating with pH sensitive polymers, coating with biodegradable polymers, designing formulations using polysaccharides, timed release system, pressure-controlled drug delivery systems, osmotic pressure controlled systems etc. Need of colon targeted drug delivery Colon targeted drug delivery system would asssure direct treatment at the disease site, lower dosing and fewer systemic side effects. Site-specific drug delivery system would allow oral administration of protein and peptide drugs, colon-specific formulation could also be used to prolong the drug delivery. Colon-specific drug delivery system is useful in the treatment of colon diseases. The colon is a site where both local or systemic drug delivery could be achieved. Topical treatment of inflammatory bowel disease, e.g. ulcerative colitis or Crohn’s disease. These inflammatory conditions are majorly treated with glucocorticoids and sulphasalazine (targeted). A number of others serious disorders of the colon, e.g. colorectal cancer, may also be capable of being treated more effectively if drugs were targeted to the colon. Formulations for colonic delivery are also suitable for delivery of drugs which are polar and/or susceptible to chemical and enzymatic degradation in the upper GI tract, highly affected by hepatic first pass metabolism, in particular, therapeutic proteins and peptides.3 Limitations and challenges in colon targeted drug delivery system A challenge in the development of colon specific drug delivery systems is to set up an appropriate dissolution testing method for in-vitro evaluation of the designed system. This is due to the rationale after a colon specific drug delivery system is quite different. As a site for drug delivery, the colon provides a near neutral pH, low digestive enzymatic activity, a long transit time and enhanced sensitivity to absorption enhancers; however, the targeting of drugs to the colon is very complicated. Owing to its location in the distal part of the alimentary canal, the colon is predominantly difficult to access. In addition to that the variation in pH values and different enzymes present throughout the gastrointestinal tract, through which the dosage form has to pass before reaching the target site, further complicate the consistency and delivery efficiency. Successful delivery through this site also needs the drug to be in solution form before it reaches the colon or alternatively, it should dissolve in the luminal fluids of the colon, but this can be a limiting factor for poorly soluble drugs as the fluid content in the colon is much lower and it is more viscous than in the upper part of the GI tract. The stability of the drug is also taken into consideration while designing a drug delivery system, because it may bind nonspecific way to dietary residues, intestinal secretions, mucus or faecal matter. Low surface area and relative tightness of the tight junctions in the colon can also limit drug transport across the mucosa and into the systemic circulation.4 Anatomy and physiology of colon The gastrointestinal tract is hollow muscular tube. It takes in nutrients and eliminate waste by such physiological processes as secretion, motility, digestion, absorption and excretion. Depending on structure and functions, the gastrointestinal tract is divided into the mouth, pharynx, oesophagus, stomach, small intestine and large intestine. The large intestine is approximately 1.5m in length and extends from the ileocaecal junctions to the anus. It is divided into four parts: caecum, colon, rectum and anal canal.5 The entire colon is approximately 5 feet (150 cm) long, and is divided into five major portions. Peritoneal folds called as mesentery which is supported by ascending and descending colon. The right colon consists of the caecum, ascending colon, hepatic flexure and the right half of the transverse colon. The left colon consists of the left half of the transverse colon, descending colon, splenic flexure and sigmoid. The rectum is the last anatomic segment before the anus. The human colon were shown in Figure1.The main functions of the colon is to make suitable environment for the growth of colonic microorganisms, storage reservoir of faecal contents, expulsion of the contents of the colon at an appropriate time and absorption of potassium and water from the lumen. The absorptive capacity is very high, at about 2000ml of fluid enters the colon through the ileocecal valve from which more than 90% of the fluid is absorbed6. The colon is involved in fermentation of polysaccharides and proteins, absorption of water and electrolytes and the formation, storage and elimination of faecal material. As a consequence of the functions of the colon, the colonic environment is generally viscous in nature. This could impact on the performance of drugs and delivery systems in this region of gut. Rapid water absorption in the ascending colon results in the distal colonic contents being more viscous. It has been estimated that the human colon contains only 220g of wet contents. In addition colon has a near neutral pH and is home to a viable microflora. These bacteria are involved in the fermentation of polysaccharides and proteins that have escaped digestion in the upper gut. Moreever the resident bacteria can also metabolize drug. The protein based drugs, insulin and calcitonin are rapidly degraded in simulated colonic contents5. Fig 1: Anatomy of colon Factors influencing colonic drug delivery: Physiological factors: 1. Transit through gastro intestinal tract Orally taken dosage forms first enters into stomach and small intestine via mouth and then reach colon. The nature and pH of the stomach affects the drug release and absorption. In order to effectively deliver tablet to colon in an intact form, the drug delivery systems should bypass the barriers in the stomach and small intestine. Gastrointestinal transit varies from 1 hr to 3 hrs depending upon the condition fasting or non-fasting respectively. In general, the small intestinal transit is not influenced by the physical state, size of the dosage form. The mean transit time of the dosage form is about 3-4 hours in order to reach the ileocecal junction and the time period is inconsistent. During this time the dosage form is exposed to enzymes present in small intestine. Compared to the other region of GIT, movement of material through the colon is slow. Total time for transit tends to be highly variable and influenced by number of factors such as diet particularly dietary fibre content , mobility, stress, disease condition and drugs. The colonic transit time is ranging from 20 to 30 hours, can be increase in presence of active disease 50 to 70 hours. Longer residence time with subsequent longer transit time and the contact of dosage form with micro flora in colon govern the release and improve absorption of drug from dosage form.7 Table 1: Transit time of dosage forms in GIT Organ Transit time(hr) Stomach >3 (fed) Small intestine 3-4 Large intestine 20-30 2. pKa of the drug, lipophilicity and gastrointestinal pH: The pH partition theory explains the process of drug absorption from the GIT and its distribution across all biological membranes. It states that for drug molecules of molecular weight greater than 100, which are mainly transported across the biological membranes by passive diffusion, the process of absorption is governed by: 1) The dissociation constant (pKa) of the drug. 2) The lipophilicity of unionized drug. 3) The pH at the absorption site. Since most of the drugs are weak electrolytes (weak acids or weak bases), their degree of ionization depends upon the pH of the biological fluid. If the pH on the either side of the membrane is different, then the compartment in which pH favors greater ionization of the drug will contain greater amount of drug, and only the unionized form of drug, if adequately lipid soluble, allowed to permeate the membrane passively until the concentration of unionized drug on both side of the membrane becomes equal i.e. until equilibrium is attained. The above statement of the hypothesis was on the basis of the assumptions that: 1) The GIT is a simple lipoidal barrier to the transport of drug. 2) Larger the fraction of unionized drug, faster the absorption(D. M. Brahmankar et al 2009). 3.pH of colon The pH of GIT varies in each individual. The food intakes, diseased state, etc.influences the pH of the GIT. This change in the pH in different regions of GIT is the basis for the development of colon targeted drug delivery systems. Coating with different polymers is done to target the drug to the site. Table 2: pH in different regions of gastrointestinal tract Part of GIT Ph Stomach (before meal) 1-2 Stomach (during digestion) 4 Smll intestine 6-7 Duodenum 6.6+0.5 Ileum 7.5+0.4 Caecum 6.4+0.4 Colon 5.5-7 Rectum 7 4. Colonic microflora A number of anaerobic and aerobic bacteria are present throghout entire length of the human GI tract. Over 400 different bacterial species have been found, 20-30% of which are of the genus bacteroids. The upper region of the GIT has a very small number of bacteria and predominantly consists of gram positive bacteria. The rate of microbial growth is greatest in the proximal areas because of high concentration of energy source. Concentration of microflora is generally about1011-1022 CFU/ml. It consists of Bacteroids, Bifidobacterium, Ruminococcus, Eubacterium and Clostridium. Chief metabolic reactions carried by the enzymes released from colonic microflora are hydrolysis and reduction. Table 3: Different microflora, enzymes and their actions Enzyme Microorganism Metabolic reactions catalysed Nitroreductase E. coli, Bacteroids Reduced aromatic and heterocyclic nitro compounds Azoreductase Clostridia, Lactobacilli, E.coli Reduced cleavage of azo compounds N oxide reductase, Sulphoxide reductase E. coli Reduced N oxides and sulphoxides Hydrogenase Clostridia, Lactobacilli Reduced carbonyl groups and aliphatic double bonds Esterases and amidases E. coli,P. vulgaris, B.subtilis, B. mycoides Cleavage of esters or amidases of carboxylic acid Glucosidase Clostridia, Eubacteria Cleavage of b- glycosidase of alcohols and phenols Glucoronidase E.coli, A. aerogenes Cleavage of b glycosidase of alcohols and phenols Sulphatase Eubacteria, streptococci Cleavage of O-sulfates and sulfamates Phamaceutical factors a) Drug candidate Drugs which show poor absorption in the stomach and intestine are most suitable for colon delivery. Drugs such as theophylline, nifedipine, diclofenac, ibuprofen, metoprolol, isoosorbide dinitrate, oxyprenolol and low molecular weight peptides and Peptide like drugs have been shown to be effectively absorbed from the colon. b) Drug carrier The selection of carrier for a particular drug candidate depends on the physicochemical nature of the drug as well as the disease for which the system is to be utilized. The factors such as chemical nature, stability and partition coefficient of drug and the type of absorption enhancers influences the carrier selection.9 Table 3: Drugs in colon targeted drug delivery Sr. No. Criteria Pharmacological class Drug and active agents 1 Drug used for local effect in colon Anti-inflammatory Drugs Oxyprenolol, Metoprolol, Nifedipine, Diclofenac, Sodium, Amylin, Antisense Oligonucleotide, 2 Drugs poorly absorbed from upper GIT Antihypertensive and antianginal drugs Ibuprofen, Isosorbides, Theophylline, Desmopressin Cyclosporine A, 3 Drugs for colon cancer Antineoplastics Pseudoephedrine, epoetin, Glucagon 4 Drugs that degrade in stomach and small intestine Peptides and proteins Bromopheniramine, 5 Flurouracil, Doxorubicin, Gonadoreline, Insulin, Interferones 5 Drugs that undergo extensive first pass metabolism Nitroglycerin and corticosteroids Nimustine, Bleomycin, Nicotine, Dexamethasone, protirelin, Sermorelin, Molgramoatim, Salotonin.

Behaviorism, Cognitivism and Constructivism

We study about three psychological school of thought Behaviorism, Cognitivism and Constructivism. In this reaction paper I notice my opinion and attitude and personal analyze about them briefly. One of the point that always think about it is that why some school of thought speak and focus on one factor of human being and deny many other factors of human nature as we see in BEHAVIORIST they believe that human nature like a tabula rasa and It assumes that each one behavior and acquisition either reflexes created by a response to sure stimulus within the environment. They didn't mention anything about inherited factors or inner of human obviously the environment, reinforcement and punishment play a great rule in acquisition but they ignore many aspect of human mind like creativity activity and looking a learner like automaton and passive creature. Radical Behaviorism maintain some important distinction with methodological form they acknowledge the view that organisms are born with innate behaviors, and also accept the role of genes and biological components in behavior. So it is more rational and moderate form of behaviorism. Cognitive theories center around the conceptualization of understudies learning procedures and address the issues of how data is gotten, sorted out, put away, and recovered by the mind. Learning is concerned not such a great amount with what students do but rather with what they know and how they come to get it. Cognitivism focus on that part of learning which deny in Behaviorism, mental activities of human mind they consider previous acquired knowledge, experiences and different abilities of each learners. They emphasize making learning significant furthermore, helping students sort out and relate new data to existing information in memory. The role of teachers in charge of helping students in sorting out that data in some ideal way. Originators utilize procedures, for example, advance coordinators, analogies, progressive connections, and grids to enable students to relate new data to earlier information. This school is more practical and flexible for considering the learner as active creature. Constructivism focus on learner and different aspect of attitude in every subject that learners can gain it. Individual and personal learning has a great role in their school. The learners in active mental process of learning should analyze and understand past experiences and adding them more details and knowledge through new experiences. We live in a real world we need practical knowledge that useful for our life so activity, knowledge, concept, culture, context are essential factors of process of learning. Plainly the focal point of constructivism is on making intellectual instruments which mirror the astuteness of the way of life in which they are utilized too as the bits of knowledge and encounters of people. There is no requirement for the mere obtaining of fixed, unique, independent ideas or subtle elements. Every different concept can be true and juxtaposition of individual ideas are gathering in social constructivism. In brief word we need all type of thinking in our world and combination of them are useful and meaningful to create more mature human being. In conclusion we can not select the best school of thought. Sometime we need to drill accents by repeation in some case we need to find out individual ability and rational and pragmatic analyze of our students. So I myself think all of them are effective in different situation and it depends on age and level of leaners and goals of lecturers. Combination of them can help us make an attractive method for language learner. Differ ideas and situation can challenge the students and help us to find out which one better work on every individual or group of learner.

The legal profession is a form of public trust

The legal profession is a form of public trust which is given only to those qualified enough to uphold the law and assist in the administration of justice. It is a duty of public service which involves sincerity, integrity and reliability, in which pecuniary considerations are a mere by-product, notwithstanding establishing lawyer-client relationships in the highest degree of fiduciary. The lawyer is an oath-bound servant of society whose conduct is clearly circumscribed by inflexible norms of law and ethics to which the ends of justice are the primary considerations. In rendering legal services to his clients, he must observe utmost fidelity to the cause of his client regardless of his personal beliefs on his client’s guilt or innocence, as even the most guilty of all criminals can still avail of the different protections afforded by the law. Sometimes, though, lawyers are faced with legal complications in providing the most adequate defenses for their clients especially when the latter are found to have deliberately violated the laws of the land. These acts do no include justifying circumstances in criminal prosecutions as these are been deemed lawful when convincingly proven in court. The acts contemplated here are acts which are considered, on its face, patent violations of the law bereft of any legal justification. However, these illegal acts do not preclude the rendering of legal services for the protection of their rights. Among the conditions and circumstances that utterly warrant the defense of illegal acts are those which are challenged based on constitutional issues involving the due process and equal protection clauses, and constitutionally-protected freedoms such as free expression and the right to privacy. The due process and the equal protection clauses have been two of the most important protections afforded by the US Constitution to the American people to safeguard them from the unwarranted intrusions of government into the free exercise of their democratic rights. As a result, many previously considered violations of the law were overturned by the US Supreme Court for abridging the due process and equal protection clauses of the constitution, to the extent that entire statutes were declared unconstitutional and taken off the statute books. In the case of Lawrence v. Texas, two gay couples were charged and convicted for â€Å"deviate sexual intercourse, namely anal sex, with a member of the same sex,† (539 U.S. 558) and violating the Texas Penal Code Ann.  §21.06(a), which provides that a person commits an offense if he engages in deviate sexual intercourse with another individual of the same sex. The homosexual couple asserted that their conviction was an infringement of the Equal Protection and Due Process Clauses of the Fourteenth amendment, in which the majority opinion answered thus These matters, involving the most intimate and personal choices a person may   Ã‚  Ã‚  Ã‚   make in a lifetime, choices central to personal dignity and autonomy, are central   Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   to the liberty protected by the Fourteenth Amendment. At the heart of liberty is   Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   the right to define one’s own concept of existence, of meaning, of the universe,    and of the mystery of human life. Beliefs about these matters could not define the   Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   attributes of personhood were they formed under compulsion of the State.   Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚     Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   Planned Parenthood of Southeastern Pa. v. Casey, 505 U.S. 833 (1992) Such homosexual acts in the privacy of a person’s home is subsumed in the concept stated above and their autonomy as persons to decide for themselves the concept of their own existence and meaning must be respected by the Court and the law. While convicted in the lower courts for violating the law, they were vindicated by the ruling of the Supreme Court based on their constitutional challenge. A case that was won based on procedural due process is the case of Tumey v. Ohio in which Tumey was arrested and charged with the unlawful possession of intoxicating liquor at White Oak, another village in Hamilton county, Ohio, on a warrant issued by the mayor of North College Hill. The mayor of the town then proceeded to try and convict Tumey under the existing law. His conviction was challenged based on the pecuniary interest of the mayor in convicting Tumey as he stood to gain from the amount of the costs in each case, in addition to his regular salary, as compensation for hearing such cases. There is, therefore, no way by which the mayor may be paid for his service as judge, if he does not convict those who are brought before him. The US Supreme Court looked favorably on the assertions of Tumey, reversed his conviction, and remanded the case for further trial, due to the utter lack of impartiality in the previous proceedings with the mayor sitting as a judge. This is proof once again that constitutional challenges protect the rights even of persons seen to have deliberately violated the law. In Lanzetta v. New Jersey, the appellants were indicted and convicted under the New Jersey Statute which prosecutes â€Å"any person not engaged in any lawful occupation, known to be a member of any gang consisting of two or more persons, who has been convicted at least three times of being a disorderly person, or who has been convicted of any crime, in this or any other State, is declared to be a gangster. The US Supreme Court declared the statute unconstitutional for being repugnant to the Fourteenth Amendment as the word â€Å"gang† and â€Å"gangster† is vague such that even those who belong to a group whose objective may be legal may unnecessarily be covered. Hence, due to vagueness, there is no sufficient warning to the public as to what exactly is proscribed by the law. The persons in this case, even if found to be true gangsters in a socio-cultural sense, had their convictions reversed simply due to the vagueness of the law. In the case of In Re Lynch, John Lynch was released from prison that supposedly condemned him for life behind bars as the US Supreme Court found the penalty for this offense of indecent exposure too cruel for such a light offense, relative to more heinous crimes with the same penalty. Lynch was definitely found guilty of his crime, yet the law still afforded him adequate protection despite his offenses when it was challenged based on the constitutional issue of disproportionate punishments which, although not cruel or unusual in its method, it is so disproportionate to the crime for which it is inflicted that it shocks the conscience and offends fundamental notions of human dignity. In New York Times v. Sullivan, the libel suit of L.B. Sullivan against the New York Times did not earn the affirmation of the US Supreme Court as it held that the interest of the public outweighs the interest of any other individual. While the New York Times might, on its face, erred in accurately reporting the facts of the civil rights demonstration involving Martin Luther King, the newspaper cannot be held for its criticisms of the official conduct of public officials.   In this case, the freedom of the press saved the New York Times from settling the multi-million dollar libel suit filed by Sullivan even if the lower courts found them guilty of the offense. In the famous case of Griswold v. Connecticut, Drs. Griswold and Buxton were found guilty of violating 53-32 and 54-196 of the General Statutes of Connecticut and fined $100 each for giving information, instruction, and medical advice to married persons as to the means of preventing conception, notwithstanding examining a married woman and prescribed the best contraceptive device or material for her use. The US Supreme Court reversed their convictions based on a discussion of the penumbra of rights which are formed by emanations from those constitutional guarantees that help give them life and substance. This is shown in past cases wherein, though not directly involved, the right to privacy was upheld. The court, in verbatim even said – The present case, concerns a relationship lying within the zone of privacy created   Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚  Ã‚   by several fundamental constitutional guarantees. And it concerns a law which, in   Ã‚   forbidding the use of contraceptives rather than regulating their manufacture or    sale, seeks to achieve its goals by means having a maximum destructive impact upon that relationship. Such a law cannot stand in light of the familiar principle, so often applied by this Court, that a â€Å"governmental purpose to control or prevent   Ã‚   activities constitutionally subject to state regulation may not be achieved by means which sweep unnecessarily broadly and thereby invade the area of   Ã‚  Ã‚  Ã‚  Ã‚   protected freedoms.† Yet again, the US Supreme Court intervened in expunging responsibility from individuals who were found to be in blatant violation of the existing laws of the land. In all of these, it is patently clear that individuals found to be in deliberate violation of existing laws can still be afforded protection by our system of laws. While many other conditions and exceptions exist to warrant the defense of supposedly erring individuals and groups, the best way of going around the violations of the law is through a sound constitutional challenge before the courts of law, from the lowest courts all the way up to the US Supreme Court. It must be remembered that these are done not only for the sheer obstinacy of defending the cause of the client but also in pursuit of upholding the rule of law, the integrity of the courts and assist in the administration of justice. The duties of the lawyers are not only to prosecute and defend, but also to ensure that justice is done to all those who deserve it. Cases Cited: Lawrence v. Texas, 539 U.S. 558 (2003) Tumey v. Ohio, 373 US 510 (1927) Lanzetta v. New Jersey, 306 US 451 (1939) In Re Lynch, 8 Cal 3rd 410 P. 2d (1972) New York Times v. Sullivan, 376 US 254 (1964) Griswold v. Connecticut, 381 US 47A (1965)   

Research On Diabetes And Its Effects On The Lives Of The...

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