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COLLEGE OF PHARMACY

COLLEGE OF PHARMACY. STERILE PRODUCTS PHT 434. TYPES OF PARENTERAL DOSAGE FORMS. Dr. Mohammad Muqtader Ahmed, PhD. Contact info: drmuqtaderx @gmail.com. Lecture outlines. Types of parenteral preparation: Solutions, Emulsion, Suspension Dry powders Facts and features

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COLLEGE OF PHARMACY

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  1. COLLEGE OF PHARMACY STERILE PRODUCTS PHT 434 TYPES OF PARENTERAL DOSAGE FORMS Dr. Mohammad Muqtader Ahmed, PhD. Contact info: drmuqtaderx@gmail.com

  2. Lecture outlines Types of parenteral preparation: • Solutions, • Emulsion, • Suspension • Dry powders • Facts and features • Advantages • Disadvantages • Method of Preparations

  3. Types of parenteral preparation • SOLUTIONS • SUSPENSIONS • EMULSIONS • DRY POWDERS

  4. Types of Parenteral preparation: solutions • Facts & Features: • Many injectable solutions are manufactured by dissolving the drug and preservative, adjusting the pH and sterile- filtering the resultant solution through a 0.22 μm membranes filter. • Solutions may be required to be a mixture of water with glycols, alcohol or other non-aqueous solvents.

  5. solutions Most solutions have the viscosity and surface tension very similar to water. There are also, examples of viscous solutions e.g. streptomycin and ascorbic acid injection. Drug solutions that resist heat, are terminally autoclave sterilized after filling; this assures product sterility and package. Heat sensitive drugs require sterile filtration and aseptic filling.

  6. Suspensions • Facts & Features: • Parenteral suspensions are formulated as a ready-to-use injection or reconstituted prior to administration. • Parenteral suspensions usually contain 0.5-5% solid (however certain antibiotic parenteral suspensions may contain up to 30% solids). • Particle size is usually less than 5 μm. • They are limited to SC, IM and intra-articular routes. • IV administration of a suspension results in vaso-occlusion.

  7. Parenteral suspensions • Advantages of suspension: • suitable for insoluble drugs • increased stability • possible depot action. • Disadvantages: • difficult formulation and manufacturing. • patient discomfort. • difficult dose uniformity.

  8. Types of parenteral preparation: EMULSIONs • Facts & features: • Lipophilic medicaments like fats, oils, fatty acids, fat soluble vitamins can be prepared as oil-in-water emulsions to be suitable for IV administration. • The dispersed droplets are 0.5-1.0 μm in diameter. • This corresponds to the size of the chylomicra; which are the natural transport systems for fat through blood stream.

  9. Types of parenteral preparation: EMULSIONs • Facts & features: • Therapeutic Values of Emulsions are: • 1. As a source of calories and essential fatty acids, as TPN and parenteral hyperalimentation. • 2. As a vehicle for drugs showing more stability , efficacy or safety in the emulsion form. • Examples: • 1.The anti-inflammatory activity of dexamethazone palmitate parenteral emulsion is 5-6 times of dexametnazone solution parenteral.

  10. Types of parenteral preparation: EMULSIONs • Facts & features: • Therapeutic Values of Emulsions are: • 2. Diazepam as parenteral emulsion showed lower toxicity than the solution form. • 3. Physostigmine salicylate emulsion is more stable than the solution form.

  11. Types of parenteral preparation: EMULSIONs • Aqueous Phase: It is usually WFI, to which additives are required to adjust osmolarity using glycerin, sorbitol, xylitoL , sodium chloride or dextrose. • Oily Phase: Natural vegetable oils such as sesame, linseed, peanut, olive or cotton seed or soya bean oils are used as oily phase for parenteral emulsions. • Emulsifiers: Natural lecithins are the most safest parenteral emulsifiers. Other options are polysorbate 80, gelatin, methylcellulose and serum albumin.

  12. Types of parenteral preparation: EMULSIONs…. • Disadvantages of Parenteral Emulsion: • Sterilization of the product is difficult, because heat influence stability and filtration is impossible. • Manufacturing process is very difficult because you are dealing with individually sterilized ingredients and under aseptic procedure. • Rapid growth of micro-organisms because parenteral emulsions do not contain preservatives as they influence stability.

  13. Types of parenteral preparation: EMULSIONs…. • Disadvantages of Parenteral Emulsion: • Emulsion is unstable system, upon storage may result in increased globule size due to coalesce and this is very dangerous because it would cause thrombosis if injected intravenously. • Long term emulsion therapy may lead to overloading syndrome (fever, anemia, hepato-spleeno-megaly)

  14. Types of parenteral preparation: DRY POWDER • Due to instability, many parenteral drug products are presented as drug powders to be reconstituted prior to administration with the correct solvent or vehicle. • When the parenteral drug powder is intended to be reconstituted, the container is labeled "for injection" or "sterile“. • For example, if it is a solution, all powder should be dissolved readily.

  15. Types of parenteral preparation: DRY POWDER • When the required is suspension, the label is "sterile for suspension“. • Suspension is forbidden for IV administration. • The obtained solution / suspension will meet with all the requirements of solution /suspension for parenteral.

  16. Types of parenteral preparation: DRY POWDER.. • METHODS OF PREPARATION • STERILE RECRYSTALLIZATION: The drug is dissolved in a solvent and the obtained solution is sterilized through 0.22 μm membrane filter. • A sterile anti-solvent is then added to crystalize the drug particles which is then filtered and dried aseptically. • Advantages:Flexible and economic. Disadvantage: contamination & variations.

  17. Types of parenteral preparation: DRY POWDER.. METHODS OF PREPARATION LYOPHILIZATION: It is a process of separating a solid substance from solution by freezing the solvent and evaporating the ice under vacuum. Drug solution is sterile filtered into sterile trays which are aseptically loaded into a freeze dryer. The solution is then frozen at -50°C and then dried by vacuum to separate the drug powder.

  18. Types of parenteral preparation: DRY POWDER • Methods of preparing a sterile drug Powder: • SPRAY DRYING: The solution of the drug is sprayed into a dry chamber where it comes in contact with a hot steam of a sterile gas. • Advantages: • 1- Suitable for heat sensitive drugs • 2- uniform particles size and density. • 3- low level of particulate • 4. low price and time consuming.

  19. Types of parenteral preparation: DRY POWDER • Methods of preparing a sterile drug Powder: • Disadvantages of spray drying: • 1.difficult to produce crystalline form of the drug: • 2.limited solvent choice for a given drug. • 3. increase haze in the reconstituted solution of certain drugs. • 4. expensive.

  20. THANK YOU FOR ATTENTION GOOD LUCK ..

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