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Mucosal Drug Delivery

Mucosal Drug Delivery

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Published by shrutibhat09

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Published by: shrutibhat09 on Feb 01, 2010
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By Dr.Shruti Bhat, Executive Pharmaceutical Applications SME, Macro2Micro,Canada.About the author :  
www.Pharm-Education.com Management of illness through medication has entered a new era in which an enormous number ofbiotechnology based products, peptides / proteins pharmaceuticals are available / synthesized fortherapeutic use. The growing interest can be ascribed to the increased understanding of their role inphysiology and therapy as well as the established capability of producing large quantities with consistentquality by the biotech route. As technological innovation spreads throughout medicine so does the"cutting edge"
come to drug delivery systems alias „
Mucoadhesive Drug Delivery
.Some examples of this system include, the BioErodible MucoAdhesive (BEMA) delivery system isdesigned to deliver either local or systemic levels of drugs across mucosal tissues. This delivery systemoffers rapid onset of action and improved drug bioavailability compared with the oral route. As an addedbenefit, drug inactivation by first-pass metabolism in the liver is avoided. The BEMA delivery systemconsists of a dime-sized disk with bioerodible layers that delivers drugs rapidly over specified timeintervals. The erosion rate is controllable, and there is no residue to remove and so far has shownpromise for the administration of pain medications, antiemetics, and antimigraine drugs (Clinical Trials,2008, February).One example of this technology is the BEMA Fentanyl mouth patch from BioDelivery SciencesInternational (Raleigh, NC), which is currently in phase III trials. It is designed to assist with breakthroughcancer pain for opioid-tolerant patients. Dr. James North, MD, principal investigator for the phase IIIefficacy study reports, "Breakthrough cancer pain can be devastating to patients with cancer and theirfamilies. Patients suffering from breakthrough cancer pain need treatment options that provide effectivepain relief and are easy to administer" (Triangle Business Journal, 2009, May) .Mucosal drug delivery technologies are expanding exponentially with applications in every imaginableroute of administration because of the indisputable therapeutic benefit this delivery technology brings.Benefits include site-specific targeting, less frequent dosing, and maintaining effective plasmaconcentration without increased consumption
The global market for advanced drug del
ivery systems was more than € 37.9 billion in 2000 and isestimated to grow and cross € 95 B (i.e., controlled release €19.8B, needle
less injection € 0.8B,
/impantable polymer systems €5.4B, transdermal € 9.6B, transnasal €12.0B, pulmonary €
7.0B, transmucosal €4.9B, rectal €0.9B, liposomal drug delivery € 2.5B, cell/gene therapy € 3.8B, and
balance covered by miscellaneous ).Table 1, mentions a brief list of representative peptide and proteindrugs and their potential functions and biomedical applications.Table 1 : List of representative peptide / protein drugs in bio-medical applications.#
Peptide / Protein drugs Functions / applications
1 Cardiovascular - active peptides & proteins-- Angiotensin II antagonist- Antriopeptins- Bradykinin- Calcitonin gene related factor- Captopril- Tissue plasminogen activator- Urokinase, streptokinase- Albumin, Plasma proteins- Lowering blood pressure.- Regulating CVS function & electrolyte & Fluidbalance.- Improving peripheral circulation.- Vasodilator.- Heart failure arrangement.- Dissolution of blood clots.- Thrombolytic therapy.- Blood volume replacement.2 CNS active peptides & proteins-- Cholecystokin (CCK-8 or CCK 32)- Delta sleep inducing peptide (DSIP)- B-endorphin- Melanocyte inhibiting factor I- Melacyte - stimulating hormone- Neuropeptide Y- Nerve growth factor- Suppressing appetite.- Improving sleep that is disturbed.- Relieving pain.- Improving the mood of depressed Patients.- Improving attention span.- Controlling feeding & drinking behavior.- Stimulating nerve growth & repair.3 GI active peptides & proteins-- Gastrin antagonist.- Neurotensin- Pancreatic enzymes- Somatostatin- Reducing secretion of gastric acid.- Inhibiting secretion of gastric juice.- Digestive supplement.- Reducing bleeding of gastric ulcers.4 Immuno modulating peptide & proteins-- Bursin- Colony stimulating factor- Cyclosporine- Enkephalins- Interferon- Selective B-cell differentiating hormone.- Stimulating granulocyte differentiation.- Inhibiting functions of Flymphocytes.- Stimulating lymphocyte blastogeneis.- Enhancing activity of killer cells.
- Muramyl dipeptide- Thymopoietin- Tumor neurosis factor- Stimulating non-specific resistance to bacterialinfections.- Selective F cell differentiating hormone.- Controlling polymorpho nuclearFunctions.5 Calcitonin, oxytocin, corticotroptin,desmopressin, vasopressin, glucagon,tetracosactideAcute or long term stimulation of endocrine axes.6 Metabolism modulating peptides andProteins-- Human growth hormone- Gonadotrophins- Insulin- Leuteinizing hormone releasing hormone(LHRH)- Oxytocin- Thyrotropin releasing hormone (TRH)- Vassopressin- treating hypopituitary dwarfism.- Inducing ovulation, spermatogenesis &cryptochialism.- Treating diabetes mellitus.- Inducing ovulation in women with hypothalamineamenorrhea.- Maintaining labor.- Prolonging infertility & lactation in women who arebreast-feeding.- Treating diabetes insipidus.7 Miscellaneous- Adenosine deaminase- Dextranase- p Fructofuranosidase-
Mannosidase- L Asparaginase- B Glucosidase- Thrombin like enzymes of snake venoms- Enzyme deficiency.- Lysosomal storage- Storage disease- Mannosidosis- Cancer-
Adult Gauctier‟s d
isease- Thrombosis
The objective of this review article is to understand the opportunities available to deliverypeptides and protein molecules as mucosal DDS and the complexities associated with theformulation thereof.
The development of delivery systems for therapeutic peptides and proteins and their evaluation dependon the biophysical, biochemical and physiological characteristics of the peptide molecules including theirmolecular size, bio half-life, immunogenicity, conformational stability, dose requirement, site & rate ofadministration, pharmacokinetics and pharmacodynamics. The immunogenic potential of any impuritiesor the peptide molecule itself must also be taken into consideration. Since, peptides are complexstructures and exhibit anomalous behavior (against conventional drug moieties) to environmental

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