SMALL AND LARGE VOLUMES PARENTERAL PREPARATIONS.pptx

about the parenteral preparations in pharmacy

1. SMALL AND LARGE VOLUMES PARENTERAL PREPARATIONS SEMINAR FOR THE SUBJECT PHARMACEUTICAL MANUFACTURING TECHNOLOGY (MQA204T) SUBMITTED TO 1 GUIDED BY:- MRS. ESHA SHAH M.PHARM KRISHNA SCHOOL OF PHARMACY PRESENTED BY:- VINIT NAI M.PHARM.,SEM-2 PHARMACEUTICAL QUALITY ASSURANCE EN NO:-2203315010 Vadodara-Mumbai National Highway 8, Vadodara, Gujarat 391240

2. CONTENT:- Introduction General requirements for Parenterals Advantages and disadvantages Classification SVP LVP Comparison M anufacturing process of Parenterals Formulation aspect Containers Evaluation of parenteral preparations 2

3. INTRODUCTION:- PARENTERALS:- The term derived  from Greek word ‛Para’ outside & ‛Enterone’ intestine. Parenterals are sterile solutions or suspension of drug in aqueous or oily vehicle. Parenteral drugs are administered directly in to the veins, muscles or under the skin, or more specialized tissues such as spinal cord. Term parenteral used for any drug/fluid whose delivery doesn’t utilize the alimentary canal for entering in to the body tissues 3

4. GENERAL REQUIREMENTS FOR PARENTERAL DOSAGE FORMS:- Stability Sterility Free from pyrogens & toxins Free from foreign particles Isotonic Chemical purity 4

5. PARENTERAL ROUTS:- The term parenteral literally means to avoid the gut (gastrointestinal tract) and refers to any route of administration outside of or beside the alimentary tract. Thus, parenteral are injectable drugs that enter the body directly and are not required to be absorbed in the gastrointestinal tract before they show their effect. Parenteral routes of administration usually have a more rapid onset of action than other routes of administration. 1. Intravenous 6. Intracardiac 2. Intramuscular 7. Intrathecal 3. Subcutaneous 8 . Intracerebral 4. intradermal 5. Intra-arterial 5

6. ADVANTAGES:- Use full for patients who cannot take drugs orally Rapid onset of action Useful for emergency situations Avoid first pass metabolism Can inject drug directly in to a tissue (target drug delivery) Useful for delivering fluids, electrolytes, or nutrients (TPN) Can be done in hospitals, ambulatory infusion centers and home health care centers Complete bioavailability. 6

7. DISADVANTAGES:- pain on injection Difficult to reverse an administered drug’s effect. Sensitivity or allergic reaction at the site of injection. Requires strict control of sterility & non- pyrogenicity than other formulation. Trained person is required. Require specialized equipment, devices, and techniques to prepare and administer drugs. More expensive and costly to produce. 7

8. CLASSIFICATION:- Based on volume they are classified into two types:- Small volume Parenterals (SVP’s) Large volume Parenterals (LVP’s) 8

9. SMALL VOLUME PARENTERALS(SVP’S):- The volume is generally less than or equal to 100ml. They are supplied in single or multiple doses. They are used to dispense most of the drugs. Examples: Ampoules, Vials, etc TYPES OF SMALL VOLUMES PARENTERAL 1. Solution 2. Suspension 3. Emulsion 4. Dry Powders 9

10. SOLUTIONS:- Typically used for delivering medications at a controlled infusion rate Most commonly solutions of 5% dextrose normal, 45% normal saline. Dextrose contributes glucose to meet energy needs and saline contributes sodium, an electrolyte that maintains fluid balance and cellular functions. 10

11. SUSPENSIONS:- They should be sterile, pyrogen free, stable, re‐suspendable, syringeable, injectable, isotonic & non‐irritating. They are usually administered by either subcutaneous (S.C.) or intramuscular (I.M.) route. These suspensions usually contain between 0.5% and 5.0% solids & should have particle size less than 5 micrometer for I.M. or S.C. administration. Certain antibiotic preparations (For example procaine, Penicillin G) may contain up to 30% solids 11

12. INJECTABLE EMULSIONS:- An emulsion is a heterogenous dispersion of one immiscible liquid in another. This inherently unstable system is made possible through the use of an emulsifying agent, which prevent coalescence of the dispersed droplet. Parenteral emulsion are rare because it is necessary (and difficult) to achieve stable droplet of less than 1 micron to prevent emboli in blood vessels and it is not usually necessary to achieve an emulsion for drug administration. 12

13. LARGE VOLUME P ARENTERALS(LVP’S):- These are supplied for single dose having more than 100 ml. These are delivered through IV route. These generally provide electrolytes, nutrition to the body. Examples: normal saline TYPES OF LARGE VOLUME PARENTERALS:- Hyper alimentation solutions Cardioplegic Solutions Peritoneal Dialysis solution Irrigating solutions 13

14. HYPERALIMENTATION SOLUTION:- Administration of large amount of nutrients to patients who unable to take food orally. Formulation: mix. Of dextrose, amino acids , lipids, electrolytes, & vitamins. TOTAL PARENTERAL NUTRITION Def. : A method of feeding patients by infusing a mixture of all necessary nutrients into the circulatory system, thus bypassing the GIT. CONTENT SOURCES 1.Calories Dextrose 2.Nitrogen Crystalline amino acids 3.Electrolytes Na, K, Cl, Po4 4.Vitamins Water soluble and fat soluble 5.elements Traces of Zn, Cu, Mn,Cr 14

15. CARDIOPLEGIC SOLUTIONS:- LVP are used in heart surgery to prevent injury to myocardium during reperfusion, as well as to maintain bloodless operating field. Maintains the diastolic arrest. Administered in cold form. Slightly alkaline to compensate metabolic acidosis, Hypertonic USE:-To minimize reperfusion injury resulting from tissue edema. 15

16. PERITONEAL DIALYSIS SOLUTION:- Infused continuously into abdominal cavity, bathing peritoneum & are then continuously withdrawn. USE:- Removal of toxic substances from body. To aid & accelerate excretion normal. To treat acute renal insufficiency. 16

17. IRRIGATING SOLUTIONS:- To  irrigate ,flush, & aid in cleaning body activities & wounds. Certain iv solution ( normal saline ) may be used as irrigating solution , but solution designed as irrigating solution should not be used parenterally. Use-: treatment of serious wounds infused in to blood stream. 17

18. OVERVIEW OF MANUFACTURING PROCESS OF PARENTERALS Planning & scheduling Equipment & facility Documentation &personal Manufacturing Bulk analysis Aseptic filling Visual inspection Q.C. Testing Sterilization Material management -Raw material & API -Packaging material Labeling & packing Finishing Warehousing 18

19. COMPARISON:- PARAMETERS SVP LVP Volume <=100ml 101-1000ml Route IV,IM,SC IV Dosage unit Single or multiple Multiple Preservatives Used Used buffer Used In composition Isotonicity Must Must pyrogenicity Must Must Formulations Solution, emulsion, suspension Solution, o/w emulsion Uses As therapeutic agent, As diagnostic agent As nutrition, detoxification, aid during surgery 19

20. PRODUCTION FACILITIES:- Clean up area Production area Aseptic area Quarantine area Finishing and packaging area 20

21. FORMULATION ASPECT:- Therapeutic agents.(API) ex: Insulin, Antibiotics, Vaccines, Antipyretics, Analgesics, Dextrose, Nacl , Electrolytes. Vehicles. 1) Water. Ex : WFI, BWFI, SWFI. 2) Aqueous vehicles. E.g.: Ethyl alcohol, Propylene Glycol. 3) Non-aqueous vehicles. E.g : Fixed oils (corn oil, peanut oil, cotton seed oil.) 21

22. ADDED SUBSTANCES(ADDITIVES):- 1)Antimicrobials. E.g.: Phenyl mercuric acetate - 0.01%, Thiomersal - 0.01%, Benzothenium chloride - 0.01%, Phenol and cresol - 0.5%. 2) Anti oxidants. E.g.: Sodium bisulfide. ascorbic acid – 0.02- 0.1%, Thiourea - 0.005%. 3) Buffering agents. E.g.: Citric acid, sodium citrate. 4)Bulking agents. E.g.: lactose – 0.14-0.5% mannitol – 0.4 – 2.5% 5)Chelating agents :- Disodium edetate – 0.003 - 0.05 % Tetra sodium edetate – 0.01 % 6) Protectants. E.g.: sucrose, lactose (2-5%) 7) Solubilizing agents. E.g.: Tweens & polysorbates. 8) Tonicity adjusting agents. E.g.: sodium sulfate – 1.1%, sorbitol – 2% 9) Surfactants. E.g.: polyethylene- 0.1 -0.5% sorbitan monooleate-0.05-0.25% 22

23. CONTAINERS:- 1.glass:- Type :1 Highly Resistant Borosilicate Glass Type II: Treated Soda lime Glass Type III: Regular Soda Lime Glass Type IV: N.P (Non-parenteral) Glass Type 4 is not used for parenteral packaging, others all are used for parenteral packaging. 23

24. PLASTIC:- Plastic containers  are used but they face following problems Permeation Sorption Leaching Softening 3.Rubber:- To provide closure for multiple dose vials, IV fluid bottles, plugs for disposable syringes and bulbs for ophthalmic pipettes, rubber is the material of choice. Problems associated with rubber closures are Incompatibility Chemical instability Physical instability 24

25. EVALUATION OF PARENTERAL PREPARATIONS :- The finished parenteral products are subjected to following tests in order to maintain quality controls: A)Sterility test B)Clarity test C) Leakage test D) Pyrogen test E) Assay 25

26. REFERENCE Lachman/Lieberman’s “The Theory and Practice Of Industrial Pharmacy” Fourth Edition 2013, Edited by: Roop K Khar, SP Vyas, Farhan J Ahmad, Gaurav K Jain, CBS Publishers and Distributors Pvt Ltd, New Delhi. Modern Pharmaceutics Fourth Edition, Revised and Expanded, Edited By G.S.Banker & C.T.Rhodes , Marcel Dekker pg387-389 https://www.slideshare.net/InnocentSutnga/large-and-small-volume-parenterals-preparations 26

27. Thank you 27