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PRESENTED BY
ROOMA KHALID
M.Phil pharmaceutics(2014-
2016)
Islamia University Bahawalpur
 Definition
 Objectives
 Indications
 Administration
 Formulation
 Compounding
 Documentation
 DEFINITION:
A method of feeding the patients by
infusing the mixture of all necessary
nutrients into the circulatory sys...
 Parental nutrition is indicated generally
when there is severe gastro-intestinal
dysfunction (patients who cannot take
s...
1:Central or total parental nutrition (TPN)
2:Peripheral parental nutrition (PPN)
1: CENTRAL OR TOTAL PARENTAL NUTRITION:
It is given via central
vein.central route is indicated when long
term feed is ant...
 For patients unable to tolerate any form of
enteral feeding, the administration of fluid
and nutrients via a parenteral ...
 To prevent unwanted weight loss and skin
break down, promoting positive nitrogen
balance and maintaining visceral and so...
 TPN reduces morbidity and mortality,
promotes tissue repair, and enhances the
immune response (Merck, n.d.)
 Johnston a...
 With an understanding of the clinical aspects
of TPN, pharmacists can recommend
regimens to fulfil the needs of the pati...
TPN is considered necessary in following
conditions:
 Patients whose GIT tract is inaccessible, non
functional, perforate...
 Pediatric GI disorders e.g prolonged diarrhea
Powell-Tuck at al reported in 1978 a
technique for administration of the total
daily requirement for TPN via a single
cont...
In an intensive care unit, for example,
requirements for fluids and electrolytes may
change rapidly throughout the day and...
For short-term therapy rotation of peripheral
entry sites may provide a simple means of
administering TPN without the comp...
Adult TPN patients generally receive 2-3
litres of fluids per day. Rapid,uncontrolled
infusion of this amount of fluid wou...
 Once TPN has been initiated on a patient it is
essential that routine monitoring is carried
out. The clinical pharmacist...
Parenteral nutrition solutions are complex
formulations that generally include energy
supplied as dextrose and fat, as wel...
1. NITROGEN:
The main objective of parental
nutrition is to supply the undernourished
patient with sufficient utilizable n...
2.AMINO ACIDS:
The body’s relative requirements of the
individual amino acids is expected as follows:
 ESSENTIAL:
Which c...
 NON ESSENTIAL AMINO ACIDS:
Those amino acids
which can normally be synthesized by the
body. These amino acids are used t...
3.ENERGY MACRO NUTIENTS
DEXTROSE:
 Dextrose is the primary source of parenteral
carbohydrate.
 Dextrose is needed by the...
 Parenteral nutrition solutions suitable for
peripheral vein administration have dextrose
concentrations of 10% or less.
...
4. LIPIDS:
Administration of lipid emulsion on a
daily, twice or three times weekly basis
appears to provide a balanced mi...
Intravenous fat emulsions are particularly
beneficial as an energy source in patients
suffering from diabetes,stress, resp...
5.ELECTROLYTES:
 Electrolytes in maintenance or therapeutic
doses need to be added daily to the
parenteral nutrition solu...
 Sodium is of critical importance in the fluid
balance of both of healthy and sick subjects.
 Sodium losses and gains ar...
 Potassium is essential for the normal
operation of the cell and is an important
determinant of cell membrane resting
pot...
 Absence of calcium from TPN in the long
term may produce symptoms of
hypocalcaemia such as muscle spasm and
numbness.
 ...
Magnesium has many physiological actions.
The most clinically significant effects of
magnesium imbalance are associated wi...
 By virtue of its buffering action phosphate
helps maintain body acid-base balance.
 If phosphate is not provided in the...
 Trace elements are essential micronutrients
that are metabolic cofactors essential for the
proper functioning of several...
 Manganese and copper are excreted through
the biliary tract, whereas Zinc, and
selenium are excreted renally.
 Therefor...
 Selenium stores have been shown to be
depleted in patients receiving long-term
parenteral nutrition or in those with the...
7. VITAMINS
 Patients on long-term TPN therapy will
generally require some vitamin
supplementation.
 The commercial prep...
 A Retinol
 B1 Thiamines
 B2 Riboflavine
 B6 Pyridoxine
 B12 Cyanocobalamin
 B Nicotinamide
 B Biotin
 B Pantothenic acid
 B Folic acid
 C Ascorbic acid
 D Calciferol
 E Tocopherol acetate
 K Phytomenadione
 Vitamins are an essential component of a
patient’s daily parenteral nutrition regimen
because they are necessary for nor...
 Vitamins that are marketed as single-entity
parenteral formulations include
 vitamins A, D, E, K, B1 (thiamine), B2
(ri...
8. FLUIDS
 In the human body, water is the predominant
chemical entity, generally accounting for
more than half of the to...
 Total water gains and losses in the healthy
adult fall within the range of 1500-3000ml
daily.
 Thus, where the patient ...
 Nutrients are mixed just prior to infusions,
by breaking the plastic connectors between
the compartments, then vitamins ...
 Because of the complexity of parenteral
nutrition products, safe preparation is a
complicated task.
 The quality of the...
 Since the inception of parenteral nutrition,
pharmacists have developed policies and
procedures for parenteral nutrition...
 Specific guidelines for aseptic processing
include media fill validations of both the
process and the personnel carrying...
 Sterile product release checks require visual
inspection against a lighted white and black
background for evidence of vi...
 Presterilized disposable membrane filtration
devices, which are sensitive in detecting low
levels of contamination and e...
 Pharmacist involved in TPN should have a
thorough understanding of the potential
stability issues in these mixtures and ...
 In general the following information will be
required on the label:
 Patient name/number
 Ward
 Product constituents
...
 Other instructions such as guidance on
administration rate or technique, limitations
on further additions etc., may also...
 Once the product has been filled and
labelled a pharmacist should perform a final
check against the prescription prior t...
 Details of further additions, storage,
conditions, expiry date, etc. should also be
confirmed and the batch number or ot...
 The hospital pharmacist may be involved in
development of nursing care guidelines with
particular reference to further a...
 Allwood at al recommends in 1984 that
compounded TPN solutions should be stored
at 2-8˚C in light of both microbiologica...
 Where supplies of compounded product are
to be made to hospitals or home patients
away from the site of manufacture, the...
 Providing a TPN compounding service within
a hospital may be a costly venture for the
pharmacy department.
 All the fac...
 Bags made of poly-ethylene and poly-
vinylchloride and of the copolymer
ethylenevinylacetate were used as containers
of ...
 Bags made of plastic materials such as
copolymer ethylene-vinylacetate (EVA), poly-
ethylene (PE) and poly-vinylchloride...
 A work sheet should be generated for each
TPN-dispensing activity to be carried out for
recording materials, patient nam...
 Prescribe the nutrient formulation
 Recognize the needs of individual patients.
 Modification in quantities according ...
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TOTAL PARENTAL NUTRITION

  1. 1. PRESENTED BY ROOMA KHALID M.Phil pharmaceutics(2014- 2016) Islamia University Bahawalpur
  2. 2.  Definition  Objectives  Indications  Administration  Formulation  Compounding  Documentation
  3. 3.  DEFINITION: A method of feeding the patients by infusing the mixture of all necessary nutrients into the circulatory system, thus by passing the GIT. Also referred to as Intravenous nutrition Parental nutrition
  4. 4.  Parental nutrition is indicated generally when there is severe gastro-intestinal dysfunction (patients who cannot take sufficient food or feeding formulas by enteral route)
  5. 5. 1:Central or total parental nutrition (TPN) 2:Peripheral parental nutrition (PPN)
  6. 6. 1: CENTRAL OR TOTAL PARENTAL NUTRITION: It is given via central vein.central route is indicated when long term feed is anticipated, high tonicity or large volume formulations are required. 2: PERIPHERAL PARENTAL NUTRITION: it is given via peripheral vein. It is indicated for patients which require short term feeding. Generally 900mOsmol/L is maximum osmolarity tolerated by the peripheral veins.
  7. 7.  For patients unable to tolerate any form of enteral feeding, the administration of fluid and nutrients via a parenteral route is necessary.  For long-term care a balanced diet containing all the essential nutrients, including vitamins and trace elements, must be provided.
  8. 8.  To prevent unwanted weight loss and skin break down, promoting positive nitrogen balance and maintaining visceral and somatic protein stores.  Illness and injury promote catabolism and hypermetabolism, so the patient is burning calories faster to keep up with his body's demands. If he doesn't get adequate nutrition, his body will break down lean muscle for glucose, which could slow healing and prolong his recovery (Collins & Navarre, 2003).
  9. 9.  TPN reduces morbidity and mortality, promotes tissue repair, and enhances the immune response (Merck, n.d.)  Johnston at al reported in 1978 that an undernourished patient whose gastrointestinal tract is temporarily or permanently unusable can increase lean body tissue and also lay down fat if fed a suitable combination of nutrients intravenously.
  10. 10.  With an understanding of the clinical aspects of TPN, pharmacists can recommend regimens to fulfil the needs of the patient as diagnosed by the physician.  Possible interactions with concomintant medication may be identified and advice given on suitable administration systems.
  11. 11. TPN is considered necessary in following conditions:  Patients whose GIT tract is inaccessible, non functional, perforated.  Undernorished patients who cannot ingest larger volumes of oral feedings and are being prepared for surgery, radiation therapy, or chemotherapy.  Disorders requiring complete bowel rest e.g ulcerative colitis
  12. 12.  Pediatric GI disorders e.g prolonged diarrhea
  13. 13. Powell-Tuck at al reported in 1978 a technique for administration of the total daily requirement for TPN via a single container. This was a significant advance over the multiple-bottle method of administration. Three-litre bag therapy, however, is not ideal for all patients.
  14. 14. In an intensive care unit, for example, requirements for fluids and electrolytes may change rapidly throughout the day and require the careful titration that can only be obtained with smaller volume fluids and injections.
  15. 15. For short-term therapy rotation of peripheral entry sites may provide a simple means of administering TPN without the complications of initiating central vein access. Silk at al reported in 1983 that for longer-term therapy a catheter placed into the superior vena cava as being the safest method of entry providing rapid dilution of the hypertonic solution.
  16. 16. Adult TPN patients generally receive 2-3 litres of fluids per day. Rapid,uncontrolled infusion of this amount of fluid would cause renal overload and would be of no benefit to the patient. It is thus vital that some form of flow control device is employed. This may range from simple clamps through to electronic drip controllers.
  17. 17.  Once TPN has been initiated on a patient it is essential that routine monitoring is carried out. The clinical pharmacist should have an understanding of the relevance of these routine tests (particularly those such as 24- hour urine analysis which is the main determinant of nitrogen requirements) in order to make adjustment to the TPN formulation.
  18. 18. Parenteral nutrition solutions are complex formulations that generally include energy supplied as dextrose and fat, as well as protein, electrolytes, trace elements,vitamins, and water. These components usually need to be individualized for patients according to their primary diagnosis, chronic diseases, fluid and electrolyte balance,acid-base status, and specific goals of parenteral nutrition.
  19. 19. 1. NITROGEN: The main objective of parental nutrition is to supply the undernourished patient with sufficient utilizable nitrogen to re-establish nitrogen balance, i.e. where the amount of nitrogen administered is approximately equal to that excreted (mainly as urea).
  20. 20. 2.AMINO ACIDS: The body’s relative requirements of the individual amino acids is expected as follows:  ESSENTIAL: Which cannot be synthesized by man. All the commercially available solutions contain the eight essential amino acids in varying proportions.
  21. 21.  NON ESSENTIAL AMINO ACIDS: Those amino acids which can normally be synthesized by the body. These amino acids are used to increase the amount of nitrogen available from the solutions.  SEMI ESSENTIAL AMINO ACIDS: Those amino acids which although they can in theory be synthesized by the body, may occasionally need to be provided in the TPN solution due to the patient's age or disease state.
  22. 22. 3.ENERGY MACRO NUTIENTS DEXTROSE:  Dextrose is the primary source of parenteral carbohydrate.  Dextrose is needed by the central nervous system, white blood cells, red blood cells, and renal medulla.  Each gram of hydrated dextrose used in parenteral nutrition yields 3.4 kcal.
  23. 23.  Parenteral nutrition solutions suitable for peripheral vein administration have dextrose concentrations of 10% or less.  Parenteral nutrition solutions with final concentrations of 10% or greater must be administered by a central vein because of the high osmolarity.
  24. 24. 4. LIPIDS: Administration of lipid emulsion on a daily, twice or three times weekly basis appears to provide a balanced mixture of nutrients for the patient requiring long-term feeding. Intravenous fat emulsions are used in parenteral nutrition as an energy source and to provide essential fatty acids.
  25. 25. Intravenous fat emulsions are particularly beneficial as an energy source in patients suffering from diabetes,stress, respiratory acidosis, and hepatic steatosis.
  26. 26. 5.ELECTROLYTES:  Electrolytes in maintenance or therapeutic doses need to be added daily to the parenteral nutrition solution to preserve electrolyte homeostasis.  Each patient’s requirements for individual electrolytes depend on the primary disease state, renal function, hepatic function, pharmacotherapy, past intake, renal or extrarenal losses, and nutritional status.
  27. 27.  Sodium is of critical importance in the fluid balance of both of healthy and sick subjects.  Sodium losses and gains are generally accompanied by similar shifts in chloride ions and a consequent movement in water.  Severe losses may lead to hypovolaemia, circulatory failure and shock. Generally a serum concentration of 135-145 mEq/litre is throught to be normal.
  28. 28.  Potassium is essential for the normal operation of the cell and is an important determinant of cell membrane resting potential.  Thus abnormally high or low levels can result in poor nerve impulse conduction, fluctuations in heart rhythm and even death due to heart failure.  It also plays a vital role in distribution of body water
  29. 29.  Absence of calcium from TPN in the long term may produce symptoms of hypocalcaemia such as muscle spasm and numbness.  The effect of lack of calcium on the growing child on TPN could understandably have a dramatic effect of growth and development of bones and teeth.
  30. 30. Magnesium has many physiological actions. The most clinically significant effects of magnesium imbalance are associated with changes in neuromuscular or cardiovascular function.
  31. 31.  By virtue of its buffering action phosphate helps maintain body acid-base balance.  If phosphate is not provided in the TPN solution hypophosphataemia may develop which can give rise to impaired red blood cell function of many organs.  Hypophosphataemia may also be induced as a result of infusion of high glucose loads.
  32. 32.  Trace elements are essential micronutrients that are metabolic cofactors essential for the proper functioning of several enzyme systems.  Zinc, Copper, Selenium, Chromium, Iron, Manganese, Cobalt, Molybdenum.  Zinc requirements are increased in metabolic stress and in gastrointestinal disease secondary to diarrheal diseases.
  33. 33.  Manganese and copper are excreted through the biliary tract, whereas Zinc, and selenium are excreted renally.  Therefore, copper and manganese should be used with caution in patients with cholestatic liver disease.
  34. 34.  Selenium stores have been shown to be depleted in patients receiving long-term parenteral nutrition or in those with thermal injury, acquired immunodeficiency syndrome, or liver failure.  Therefore, selenium should be added initially to the parenteral nutrition solution for patients with these disease states or conditions.
  35. 35. 7. VITAMINS  Patients on long-term TPN therapy will generally require some vitamin supplementation.  The commercial preparations of vitamins available along with recommended daily requirements which seem to vary according to the current available recommendations.
  36. 36.  A Retinol  B1 Thiamines  B2 Riboflavine  B6 Pyridoxine  B12 Cyanocobalamin  B Nicotinamide  B Biotin
  37. 37.  B Pantothenic acid  B Folic acid  C Ascorbic acid  D Calciferol  E Tocopherol acetate  K Phytomenadione
  38. 38.  Vitamins are an essential component of a patient’s daily parenteral nutrition regimen because they are necessary for normal metabolism and cellular function of the body.  Individual parenteral vitamins are recommended when the multivitamins products are not available.
  39. 39.  Vitamins that are marketed as single-entity parenteral formulations include  vitamins A, D, E, K, B1 (thiamine), B2 (riboflavin), B3 (niacin), B6 (pyridoxine), B9(folic acid), B12 (cyanocobalamin) , and C (ascorbic acid).
  40. 40. 8. FLUIDS  In the human body, water is the predominant chemical entity, generally accounting for more than half of the total body weight.  An inverse relationship exists between the amount of body fat and the amount of body water present in an individual.
  41. 41.  Total water gains and losses in the healthy adult fall within the range of 1500-3000ml daily.  Thus, where the patient requires TPN, the volume administered will fall into this range and may need to be supplemented by additional fluids in the special cases of burns, etc.  Careful patient monitoring is required to ensure that they do not become dehydrated.
  42. 42.  Nutrients are mixed just prior to infusions, by breaking the plastic connectors between the compartments, then vitamins and trace elements are added extemporaneously to the bag.  Shelf –life of these bags is at least 12 months, but allow only for standardized formulas.  The use of three-compartment TPN bags is less expensive in terms of application costs than separate bottles or hospital- compounded bag systems.
  43. 43.  Because of the complexity of parenteral nutrition products, safe preparation is a complicated task.  The quality of the final product depends on the facilities, resources,personnel training and products used in preparation.
  44. 44.  Since the inception of parenteral nutrition, pharmacists have developed policies and procedures for parenteral nutrition compounding based on their training and interpretation of the literature.  Parenteral nutrition is considered a high-risk sterile product. Its compounding includes complex and/or numerous aseptic manipulations.
  45. 45.  Specific guidelines for aseptic processing include media fill validations of both the process and the personnel carrying out the process.  There are specific requirements for facilities, space and environmental control similar to those of a Class 100 clean-room environment.
  46. 46.  Sterile product release checks require visual inspection against a lighted white and black background for evidence of visible particulates or other foreign matter.  In addition,compounding accuracy checks of the addition of all drug products or ingredients used to prepare the parenteral nutrition product are ensured by validating the volume and quantity used in admixture.
  47. 47.  Presterilized disposable membrane filtration devices, which are sensitive in detecting low levels of contamination and easy to use, are commercially available.  The compounding of parenteral nutrition admixtures accelerates the rate of physicochemical destabilization, resulting in the recommendation to administer parenteral nutrition as soon after its preparation as possible certain amino acids, lipids, and multivitamins are most susceptible to instability.
  48. 48.  Pharmacist involved in TPN should have a thorough understanding of the potential stability issues in these mixtures and be able to advise physicians accordingly.
  49. 49.  In general the following information will be required on the label:  Patient name/number  Ward  Product constituents  Batch (dispensing number)  Expiry date/time  Storage conditions
  50. 50.  Other instructions such as guidance on administration rate or technique, limitations on further additions etc., may also be required.
  51. 51.  Once the product has been filled and labelled a pharmacist should perform a final check against the prescription prior to sending the product to the ward.  This check should include the patient’s name, ward, etc. and should once again compare the constituents requested against the final label.
  52. 52.  Details of further additions, storage, conditions, expiry date, etc. should also be confirmed and the batch number or other reference allocated should be checked to facilitate traceability in the event of any difficulties arising subsequent to dispensing, e.g. precipitation, discoloration, etc.
  53. 53.  The hospital pharmacist may be involved in development of nursing care guidelines with particular reference to further additions, storage, etc.  It may also be useful for the ward pharmacist to check that TPN is being correctly administered to the patient, i.e. with correct flow control device, away from direct sunlight, etc.
  54. 54.  Allwood at al recommends in 1984 that compounded TPN solutions should be stored at 2-8˚C in light of both microbiological and chemical considerations.  Should not be stored at room temperature for periods in excess of the 12-24 hours required for administration.
  55. 55.  Where supplies of compounded product are to be made to hospitals or home patients away from the site of manufacture, the quality of the packaging system to maintain product temperature during transit should be validated to the satisfaction of local quality control standards.  Insulated polystyrene containers may be useful for this purpose.
  56. 56.  Providing a TPN compounding service within a hospital may be a costly venture for the pharmacy department.  All the factors must be considered when developing true service costs and deciding whether to produce in house or obtain product from a regional hospital or commercial source.
  57. 57.  Bags made of poly-ethylene and poly- vinylchloride and of the copolymer ethylenevinylacetate were used as containers of perfusion solutions for total parenteral nutrition.  Injectable solutions for Total Parenteral Nutrition containing L- aminoacids,electrolytes and glucose, are commonly sold as medicinal specialities in glass containers.
  58. 58.  Bags made of plastic materials such as copolymer ethylene-vinylacetate (EVA), poly- ethylene (PE) and poly-vinylchloride (PVC) are being used more and more often in the manufacture of containers of perfusion solutions.
  59. 59.  A work sheet should be generated for each TPN-dispensing activity to be carried out for recording materials, patient name, label details, etc.  The format for such a work sheet should be agreed between the production and quality control departments of the hospital in accordance with local policy.
  60. 60.  Prescribe the nutrient formulation  Recognize the needs of individual patients.  Modification in quantities according to clinical situation of patients.  Monitor the interactions among various electrolytes and drugs affect TPN mixture.  Assist the health care team in developing a cost effective formulary of nutrition products.
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