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PRESERVATIVES, PRESERVATION OF PHARMACEUTICAL PRODUCT,

PRESERVATIVES, PRESERVATION OF PHARMACEUTICAL PRODUCT,

PHARMAROCKS
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PRESERVATIVES, PRESERVATION OF PHARMACEUTICAL PRODUCT,

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  1. PRESERVATIVES PRESERVATION OF PHARMACEUTICAL PRODUCTS USE OF ANTIMICROBIAL AGENTS AS PRESERVATIVE

  2. Preservatives Prevent the growth of unwanted and harmful microorganisms in pharmaceutical products. Preservatives are the chemical substances used to improve or amplify shelf life of drugs by decreasing or lowering the oxidation of active ingredients or excipients and by reducing microbial production

  3. Preservatives A chemical substance used to preserve organic substance from decay or spoilage by preventing microbial attack. A pharmaceutical Preservatives prevent microbial spoilage by prevent growth of microorganism in that product.

  4. Preservatives Examples Methyl Parabens, Ethyl Parabens, Propyl Parabens Butyl Parabens, Sorbic acid. Na, K & Ca Sorbate, Benzoic acid, Na, K & Ca Benzoate, Sodium metabisulfite, Propylene glycol (15-30%). BHT (butylated hydroxytoluene) BHA (Butylated hydroxyanisole) benzaldehyde, Essential Oils, Phenol compounds Mercury compounds

  5. Need of Preservatives 1. To protect our drug from microbial attack 2. To enhance activity and efficacy of drug 3. To increase shelf life of our product 4. To stabilize our product 5. To improve product self life. 6. to maintain quality of product.

  6. Ideal properties of preservatives 1. Should able to kill all microbes contaminants rapidly 2. Tasteless and odourless 3. They must be non-irritant 4. Non toxic to the patient 5. Physically and chemically Stable 6. They must be non reactive 7. Highly soluble

  7. Ideal properties of preservatives 8. Cost effective 9. Compatible with drug components 10. Effective at low concentration throughout the life of the medicine. 11. Should be selective in reacting with contaminants 12. Should not react with ingredients of the medicine. 13. It must decrease the percentage of the microbes and prevent any re-growth

  8. Types of preservatives 1. Microbiostatic: those that inhibit their growth are called microbiostatic. 2. Microbiocidal: those that kill microbe are called microbiostatic. A microbiocide is any biocidal compound or substance with the purpose of reducing the infectivity of microbes, such as viruses or bacteria.

  9. Preservatives in combination A single preservative is not suitable for preservation of all pharmaceutical formulations. Some preservatives are ineffective with some microbe strains and should be combined with others to be effective. Combination of two or more preservatives are used to extend the range and spectrum of preservation.(Synergic action)

  10. Preservatives in combination Germall 115+parabens (antibacterial +antifungal)-Tablets, Capsule Phenylethyl alcohol + phenoxetol + benzalkonium chloride (wide antimicrobial) -Eye drops and contact lens Methyl Para hydroxybenzoic acid and propyl Para hydroxybenzoic acid (antimicrobial) –Injection

  11. Types of preservatives In nature some preservatives are ineffective with some microbe strains and should be combined with others to be effective. Such as – 1. Benzalkonium chloride 2. Organo mercurial 3. Cetrimide, 4. Chlorhexidine 5. 3-cresol are combined

  12. RECOMMENDED PRESERVATIVE CONCENTRATION GENERAL RECOMMENDED PRESERVATIVE CONCENTRATION 1. Benzyl Alcohol 0.5 to 10% 2. Benzalkonium Chloride 0.01% 3. Chlorobutanol 0.25 to 0.5% 4. Methyl Paraben 0.01 to 0.5% 5. Phenol 0.065 to 0.02%

  13. RECOMMENDED PRESERVATIVE CONCENTRATION Preservative Concentration for Liquid Oral Preparation 1. Benzoic Acid 0.1 to 0.2% 2. Sorbic Acid 0.1 to 0.2% 3. Methyl Paraben 0.25% 4. Propyl Paraben 0.5 to 0.25% 5. Sodium Benzonate 0.1 to 0.2% 6. Bronidol 0.001 to 0.05%

  14. Classification of preservation Based on mechanism of action 1. Antioxidants 2. Antimicrobial agents 3. Chelating agents Based on sources Natural preservatives Artificial preservatives

  15. ANTIOXIDANTS The agent which prevent oxidantion of API which otherwise undergo degradation due to oxidation as they are sensitive to oxygen. Examples: Vitamin E & C, Butylated hydroxy anisole (BHA), Butylated hydroxy toluence(BHT).

  16. ANTIMICROBIAL AGENTS The agent which active against gram +ve and gram –ve microbes which causes degradatation of pharmaceutical preparation which are active in low concentration. Examples: Benzoates, Sodium benzoate, Sorbates.

  17. CHELATING AGENTS The agents which form the complex with pharmaceutical ingredient and prevent the degradation of pharmaceutical formulation. Examples: EDTA, Polyphosphates, Citric acid

  18. NATURAL PRESERVATIVES These preservatives are obtained from natural sources like plants, minerals and animal sources, etc Examples: Neem oil, Lemon, Honey Salt(sodium chloride),

  19. ARTIFICIAL PRESERVATIVES These are man made by chemical synthesis and active against various microbes in small concentration. Examples: Benzoates, Sodium benzoate, Sorbates, Propionets, Nitrites.

  20. Preservatives and their side effects

  21. Preservatives and their side effects

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