Protein and peptide drug delivery

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PROTEIN AND PEPTIDE DRUG DELIVERY:

BY V. S. N. MURTHY RESEARCH SCHOLAR DEPARTMENT OF PHARMACEUTICS UNIVERSITY COLLEGE OF PHARMACEUTICAL SCIENCES ACHARYA NAGARJUNA UNIVERSITY PROTEIN AND PEPTIDE DRUG DELIVERY

CONTENTS:

CONTENTS INTRODUCTION ADVANTAGES ROUTES OF ADMINISTRATION PARENTRAL NON-PARENTRAL DEVELOPMENT OF DELIVERY SYSTEM CONCLUSION REFERENCES

INTRODUCTION:

INTRODUCTION Proteins and peptides are most abundant components of biological cells not only structural components but also functional moieties. Amino acids linked together in a sequential manner by peptide bond resulting the formation of protein.

TYPES OF PROTEINS AND PEPTIDES:

TYPES OF PROTEINS AND PEPTIDES Depending on the number of amino acids they are classified as follows Polypeptides Oligopeptides Protein Fibrous proteins Globular proteins Oligomeric proteins

ADVANTAGES:

ADVANTAGES Erythropoietin is used for production of Red blood cells Oxytosine maintains labour pains Somatostatins decreases bleeding of gastric ulcers Vasopressin treats diabetes insupidis Bradykinins increases peripheral circulation.

ROUTES OF ADMINISTRATION:

ROUTES OF ADMINISTRATION PARENTERAL NON PARENTERAL I.M ORAL I.V BUCCAL S.C NASAL RECTAL TRANSDERMAL PULMONARY

PARENTRAL ROUTES OF ADMINISTRATION:

PARENTRAL ROUTES OF ADMINISTRATION parentral route is most efficient way for systemic delivery of proteins and peptides This is the best choice to achieve therapeutic activity. Mainly 3 routes of administration are used. INTRAVASCULAR INTRAMUSCULAR SUBCUTANEOUS

ADVANTAGES: :

ADVANTAGES : Fast absorption Avoid First pass effect. DISADVANTAGES: Short duration of their biological action stimulate immunogenic response

INTRAVENEOUS ROUTE :

INTRAVENEOUS ROUTE Excessively metabolized and tissue drug bound at the site of IM can be administered by this route EX:Insulin, Interferon DISADVANTAGES: Causes pain, tissue necrosis and thrombopenia ADVANTAGES Antibiotics can be administered.

INTRAMUSCULAR ROUTE :

INTRAMUSCULAR ROUTE Gamma globulins given by this route are proved to have long-term protection from hepatic infection. some drugs given by this route include long acting insulin, GH. DISADVANTAGES: Not used for all proteins and peptide drugs because of metabolism of drugs at the site of injection

SUBCUTANEOUS ROUTE:

SUBCUTANEOUS ROUTE Controlled release is obtained from implantable polymeric devices These are prepared from crossed linked polymers which are biocompatible and biodegradable. EX: polylactic acid Release of Insulin, bovine serum albumin, LH was prolonged by this route.

NON-PARENTRAL ROUTES :

NON-PARENTRAL ROUTES ORAL ROUTE OF ADMINISTRATION Most popular route of drug delivery Advantages: convenience patient compliance acceptability

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Disadvantages potential degradation by proteolytic enzymes, strong acids Very low permeability across gastrointestinal mucosa. First pass metabolism

BUCCAL ROUTE OF ADMINISTRATION:

BUCCAL ROUTE OF ADMINISTRATION The drugs are absorbed through oral mucosa mainly through the non-keratinized regions ADVANTAGES: It can be attached or removed without any discomfort and pain Well acceptability by patients Drugs are absorbed rapidly

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DISADVANTAGES: Administration time is limited Drug loss by accidental swallowing Drugs administered by this route are insulin, vasopressin, oxytosine

NASAL ROUTE OF ADMINISTRATION:

NASAL ROUTE OF ADMINISTRATION The nasal route has been employed for producing local action on the mucosa which is more permeable compared to oral mucosa. Nasal absorption is through passive diffusion EX: Insulin, human growth hormone.

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ADVANTAGES : Rapid onset of action First pass metabolism can be avoided Better drug absorption DISADVANTAGES: Long-term usage causes toxicity Size of proteins and peptide drugs reduces systemic bioavailability.

TRANSDERMAL ROUTE OF ADMINISTRATION:

TRANSDERMAL ROUTE OF ADMINISTRATION This is topical medication. Drug is absorbed through the skin. EX:Insulin , vasopressin ADVANTAGES: Controlled administration of drug is possible. Improved patient compliance. Drugs with short half lives can be administered.

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DISADVANTAGES : High intra and inter patient variability Low permeation because of high molecular weight Hydrophilicity and lipophilicity of stratum corneum

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Number of approaches are available for effective protein and peptide drug delivery. They are IONTOPHORESIS PHONOPHORESIS PENETRATION ENHANCERS PRODRUG

PULMONARY ROUTE OF ADMINISTRATION:

PULMONARY ROUTE OF ADMINISTRATION Lungs are attractive site for systemic delivery of proteins and peptides because of their enormous surface area(70 sq.m) Alveoli and lungs are the absorption sites. Drugs are absorbed through lungs by simple diffusion,carrier mediated transport.

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ADVANTAGES: Decrease in dose requirement. Fast absorption Increased patient compliance DISADVANTAGES: Inflammation may be observed in lungs. Degree of bioavailability was less due to hydrolytic enzymes present in lungs.

RECTAL ROUTE OF ADMINISTRATION :

RECTAL ROUTE OF ADMINISTRATION Rectum is highly vascularised body cavity Rectal mucosa is devoid of villi Drugs are in form of suppositories, gel, dry powders. EX:Insulin,calcitonin

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ADVANTAGES: Reduced proteolytic degradation Improved systemic bioavailability with co-administration of absorption enhancers. EX:surfactants Large dose can be administered

DEVELOPMENT OF DELIVERY SYSTEM:

DEVELOPMENT OF DELIVERY SYSTEM FORMULATION CONSIDERATIONS. Preformulation considerations Surface adsorption behaviour stability profiles. PHARMACOKINETIC CONSIDERATIONS ANALYTICAL CONSIDERATIONS REGULATORY CONSIDERATIONS

FORMULATION CONSIDERATIONS :

FORMULATION CONSIDERATIONS The development of delivery system for therapeutic proteins and peptides & their evaluation depend on physical, chemical characters such as molecular weight, immunogenicity, half-life. Preformulation studies. Surface adsorption theory.

STABILITY PROFILE:

STABILITY PROFILE PHYSICAL CHEMICAL DENATURATION DEAMIDATION ABSORPTION PROTEOLYSIS AGREGGATION RACEMISATION PRECIPITATION OXIDATION

PHARMACOKINETIC CONSIDERATIONS:

PHARMACOKINETIC CONSIDERATIONS Similar to those of other drugs but have some problems like Less biological half life Instability at absorption site. Sampling errors. presence of binding proteins.

ANALYTICAL CONSIDERATIONS:

ANALYTICAL CONSIDERATIONS Can be analyzed using techniques like Radioimmuno assay HPLC

CONCLUSION:

CONCLUSION Protein & peptide pharmaceuticals are very important class of therapeutic agents. Their need in the clinical & therapeutic regions has intensified the investigation for their convenient & effective delivery through noninvasive system.

REFERENCES:

REFERENCES Novel drug delivery systems By Yie.W.chien Progress in controlled & novel drug delivery by N.K.Jain. Controlled drug delivery concepts and advances by S.P vyas & Roop k.khar

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