- Email: [email protected]
Manufacture in the Hospital
It Pays to
MANUFACTURE IN THE HOSPITAL by LAWRENCE TEMPLETON UNIVERSITY OF ILLINOIS COLLEGE OF PHARMACY
COMPOUNDING PHARMACEUTICAL.S UNDER CONTROL SYSTEM IN THE HOSPITAL PHARMACY PROVIDES PHYSICIANS WITH A FLEXIBLE, ECONOMICAL MEDICATION SOURCE
C lng be clearly demonstrated to the hospital administration?
~N the value of pharmaceutical manufactur-
Should only the larger hospitals consider manufacturing? "Yes, " is the writer's answer to the first· "no, not necessarily," answers the second of th~ two questions which ofttimes arise when manufacturing in the hospital pharmacy is being considered. Nothing is so convincing as success, and this is to be found in both large and small hospitals where the pharmacy has undertaken manufacturing. The following viewpoints arise from experience in supervising pharmaceutical manufacturing in the hospital pharmacy associated with the University of Illinois College of Pharmacy, which supplies the Research and Educational Hospital. In comparison to the average hospital pharmacy engaged in manufacturing, our scale of operations might be classified as large. The annual report for the calendar year of 1942 discloses the manufacture of 1200 gallons of liquids, a ton of ointments, 800,000 tablets, and many other items. Volume for this year will be considerably greater as more products are being manufactured which were formerly purchased. The report does not include parenteral solutions which are manufactured in a separate unit of the hospital pharmacy. From the operation of this manufacturing unit, a conviction has been formed of the feasibility of such an undertaking. In the operation of a comparatively large unit the role of a much smaller unit is readily envisioned. ~ented by titJe to American Society of Hospital Ph _ maclsts, A. PH. A., Columbus meeting, 1943.
ar
Conversations with individual hospital pharmacists and group discussions both give the impression that the majority of hospital pharmacists believe that the practice of hospital pharmacy should be limited to filling orders, compounding prescriptions and dispensing or repackaging products manufactured by the pharmaceutical concerns. It is possible that many pharmacists do hold this opinion, as they already carry a maximum burden of duties. On the other hand, it may be argued that the establishment of a manufacturing unit may provide the means for the employment of an additional pharmacist. Manufacturing might not require all of the time of this pharmacist who could otherwise assist with diverse functions of the pharmacy. Cost, quality and service-these are the three important features of supplying pharmaceuticals to a hospital. Proposing increased expense to the hospital through the employment of additional help and the purchase of equipment must be justified economically with concrete evidence. This can be supplied by figures showing the cost of mat~als, estimated cost of manufacture, cost of necessary equipment, depreciation of machinery and the production time required. It should be possible to obtain this information from hospital pharmacists who have successfully operated a manufacturing unit, preferably from those using approximately the same amount of products as your own would use. Except for occasional instances, the cost of producing pharmaceuticals in our laboratory is less than the cost of buying them on the open market. Obviously, this advantage would not exist if certain products were manufactured in smaller lots. There are many other products, however, whose manufacture is adaptable to small-scale production. Most of the liquid preparations, for example, employ little equipment for manufacture, if any. In this group may be listed such commonly used
362
PRACTICAL PHARMACY EDITION
363
products as syrups, elixirs, aqueous and alcoholic The quality of the manufactured product is of solutions, mouth washes, deodorant solutions, paramount importance. The first step is the nasal and ophthalmic solutions, baby oils, etc. topnotch quality of the ingredients. Then a Amechanical mixer with variable speeds and of system of manufacturing control should be emsuitable size is usually practical. Mechanical ployed. A simple system is the use of a formula filtering equipment is recommended for quantities card of appropriate size so that it may be used for over five gallons. at least ten lots, or for the calendar year. The A mixer of the type used in bakeries is suitable formula should be carefully checked for correctfor mixing ointments, either by the cold process ness of calculations. In the allotted space on the or when the base is melted. An ointment mill is formula card the initials of the manufacturing anecessity for the quantity production of smooth pharmacist should be placed to signify that the ointments containing undissolved solid material. ingredient has been weighed or measured. The Tablet manufacture is an art unto itself about checking of all ingredients, weights and measurewhich general information is of limited value. ments by a second party should be a requirement. Even with specific information, allowances must Another simple method for manufacturing be made for the experience of the operator, the control is the use of work sheets transcribed from conditions of manufacture and the equipment. It a master formula. Dates and checks for weighing has been our experience that the amount of ma- and measuring are recorded on this sheet in additeriallost in the manufacture of tablets remains tion to the final stamping of a control number practically the same regardless of the size of the which is also stamped on the label of the product. lot. In other words, the per cent of loss for a lot In many instances a sample of the product bearof 5000 would be greater than for a lot of 25,000. ing the control number should be reserved for For some unaccountable reason a few of the com- assay and as an index of stability. monly-used tablets may be purchased for no Proof of the quality of the product lies in more than the cost of the drugs which enter into physical appearance, stability, disintegration the tablet. Generally speaking, however, if a rate for tablets and assay of the active ingredisufficient number of tablets are manufactured in ents. Initial and subsequent occasional assays lots of 5000 or more a saving may be effected and should be run on many products, and, in particuthe purchase of equipment is warranted. lar, tablets. In the case of the simple mixing of ingredients previously assayed by the manufacturers, an assay of the finished product should not Savings Cited always be necessary provided that a definite and The manufacture of two products is cited to adequate system of control is used. Manufacturing in the hospital pharmacy offers serve as examples of economy. By the purchase of light magnesium oxide in 40-pound lots, a a special service to staff physicians who desire U. S. P. grade of milk of magnesia can be pro- to use formulas which do not compare in compoduced at a total ingredient cost of not more than sition to those supplied by the pharmaceutical 15 cents a gallon. The necessary equipment is a concerns. For various reasons the physician high-speed mixer of at least one-gallon capacity. may also desire a modification of a U. S. P. or Final treatment with a colloid mill or homogen- N. F. formula. In other words, the physician is izer is optional. For those using a considerable not limited to what is available on the market. amount of aluminum hydroxide gel, a quality Most physicians are always on the alert for better product can be produced by adding water to a forms of medication and it is here that the pharconcentrate at an intredient cost of about eight macist is in a position to develop new formulas for cents a pint. Using the precipitation process the physicians which will enhance his prestige (aluminum sulfate and sodium carbonate), the as a pharmacist and improve the medications. Featuring the arguments of economy and servgel may be produced in any quantity at about the same ingredient cost but with a higher labor ice to the hospital, backed up by investigation of cost. Formulas are available for the addition hospital pharmacies where manufacturing is of magnesiilm trisilicate, kaolin or mineral oil to conducted, the hospital pharmacist should be the gel. A high-speed mixer is required for the able to convince the administration that the eshydration process and also a colloid mill or homo- tablishment of a manufacturing unit is worthy genizer (a colloid mill preferred) for either process. of consideration.
364
JOURNAL OF THE AMERICAN PHARMACEUTICAL ASSOCIATION
ANNOU THE UNION OF TWO GREAT
NEO-SYNEPHRINE SULFATHIAZOLATE for topical treatment of colds and sinusitis-is available in i-oz. (with dropper) and i6-oz. bottles as a 0.6 per cent solution in a buffired, approximately isotonic vehicle.
365
PRACTICAL PHARMACY EDITION
NC ING THERAPEUTIC AGENTS
N eo-S¥neRhrine Sulfathiazolate combines powerful vasoconstriction and potent bacteriostasis in one stable chemical compound In response to widespread demand, Stearns research has linked into one stable chemical compound the unique advantages of the outstanding vasoconstrictor N eo-Synephrine Hydrochloride, and the equally well-known qualities of sulfathiazole. And this combination has been effected without diminishing the therapeutic value of either agent, and without sacrificing safety. Vasoconstriction is fast, prolonged and without appreciable cardiac or psychic reaction or local irritation - and bacteriostasis is equivalent to that of
Fredenck
sodium sulfathiazole-an ideal combination for dual-action treatment of colds and sinusitis. Now being introduced to physicians through one of the most intensive advertising and detailing programs ever put behind a new professional product, Neo-Synephrine Sulfathiazolate is obviously a product of tremendous potential as a big, steady profitmaker. Check your stock . . . note your needs . . . and order today.
Stearns
& Company
Since 1855 ... ESSENTIALS OF THE PHYSICIAN'S ARMAMENTARIUM NEW YORK
KANSAS CITY
DETROIT, MICH.
SYDNEY, AUSTRALIA
SAN FRANCISCO
AUCKLAND, NEW ZEALAND
WINDSOR, ONTARIO
MANUFACTURE IN THE HOSPITAL by LAWRENCE TEMPLETON UNIVERSITY OF ILLINOIS COLLEGE OF PHARMACY
COMPOUNDING PHARMACEUTICAL.S UNDER CONTROL SYSTEM IN THE HOSPITAL PHARMACY PROVIDES PHYSICIANS WITH A FLEXIBLE, ECONOMICAL MEDICATION SOURCE
C lng be clearly demonstrated to the hospital administration?
~N the value of pharmaceutical manufactur-
Should only the larger hospitals consider manufacturing? "Yes, " is the writer's answer to the first· "no, not necessarily," answers the second of th~ two questions which ofttimes arise when manufacturing in the hospital pharmacy is being considered. Nothing is so convincing as success, and this is to be found in both large and small hospitals where the pharmacy has undertaken manufacturing. The following viewpoints arise from experience in supervising pharmaceutical manufacturing in the hospital pharmacy associated with the University of Illinois College of Pharmacy, which supplies the Research and Educational Hospital. In comparison to the average hospital pharmacy engaged in manufacturing, our scale of operations might be classified as large. The annual report for the calendar year of 1942 discloses the manufacture of 1200 gallons of liquids, a ton of ointments, 800,000 tablets, and many other items. Volume for this year will be considerably greater as more products are being manufactured which were formerly purchased. The report does not include parenteral solutions which are manufactured in a separate unit of the hospital pharmacy. From the operation of this manufacturing unit, a conviction has been formed of the feasibility of such an undertaking. In the operation of a comparatively large unit the role of a much smaller unit is readily envisioned. ~ented by titJe to American Society of Hospital Ph _ maclsts, A. PH. A., Columbus meeting, 1943.
ar
Conversations with individual hospital pharmacists and group discussions both give the impression that the majority of hospital pharmacists believe that the practice of hospital pharmacy should be limited to filling orders, compounding prescriptions and dispensing or repackaging products manufactured by the pharmaceutical concerns. It is possible that many pharmacists do hold this opinion, as they already carry a maximum burden of duties. On the other hand, it may be argued that the establishment of a manufacturing unit may provide the means for the employment of an additional pharmacist. Manufacturing might not require all of the time of this pharmacist who could otherwise assist with diverse functions of the pharmacy. Cost, quality and service-these are the three important features of supplying pharmaceuticals to a hospital. Proposing increased expense to the hospital through the employment of additional help and the purchase of equipment must be justified economically with concrete evidence. This can be supplied by figures showing the cost of mat~als, estimated cost of manufacture, cost of necessary equipment, depreciation of machinery and the production time required. It should be possible to obtain this information from hospital pharmacists who have successfully operated a manufacturing unit, preferably from those using approximately the same amount of products as your own would use. Except for occasional instances, the cost of producing pharmaceuticals in our laboratory is less than the cost of buying them on the open market. Obviously, this advantage would not exist if certain products were manufactured in smaller lots. There are many other products, however, whose manufacture is adaptable to small-scale production. Most of the liquid preparations, for example, employ little equipment for manufacture, if any. In this group may be listed such commonly used
362
PRACTICAL PHARMACY EDITION
363
products as syrups, elixirs, aqueous and alcoholic The quality of the manufactured product is of solutions, mouth washes, deodorant solutions, paramount importance. The first step is the nasal and ophthalmic solutions, baby oils, etc. topnotch quality of the ingredients. Then a Amechanical mixer with variable speeds and of system of manufacturing control should be emsuitable size is usually practical. Mechanical ployed. A simple system is the use of a formula filtering equipment is recommended for quantities card of appropriate size so that it may be used for over five gallons. at least ten lots, or for the calendar year. The A mixer of the type used in bakeries is suitable formula should be carefully checked for correctfor mixing ointments, either by the cold process ness of calculations. In the allotted space on the or when the base is melted. An ointment mill is formula card the initials of the manufacturing anecessity for the quantity production of smooth pharmacist should be placed to signify that the ointments containing undissolved solid material. ingredient has been weighed or measured. The Tablet manufacture is an art unto itself about checking of all ingredients, weights and measurewhich general information is of limited value. ments by a second party should be a requirement. Even with specific information, allowances must Another simple method for manufacturing be made for the experience of the operator, the control is the use of work sheets transcribed from conditions of manufacture and the equipment. It a master formula. Dates and checks for weighing has been our experience that the amount of ma- and measuring are recorded on this sheet in additeriallost in the manufacture of tablets remains tion to the final stamping of a control number practically the same regardless of the size of the which is also stamped on the label of the product. lot. In other words, the per cent of loss for a lot In many instances a sample of the product bearof 5000 would be greater than for a lot of 25,000. ing the control number should be reserved for For some unaccountable reason a few of the com- assay and as an index of stability. monly-used tablets may be purchased for no Proof of the quality of the product lies in more than the cost of the drugs which enter into physical appearance, stability, disintegration the tablet. Generally speaking, however, if a rate for tablets and assay of the active ingredisufficient number of tablets are manufactured in ents. Initial and subsequent occasional assays lots of 5000 or more a saving may be effected and should be run on many products, and, in particuthe purchase of equipment is warranted. lar, tablets. In the case of the simple mixing of ingredients previously assayed by the manufacturers, an assay of the finished product should not Savings Cited always be necessary provided that a definite and The manufacture of two products is cited to adequate system of control is used. Manufacturing in the hospital pharmacy offers serve as examples of economy. By the purchase of light magnesium oxide in 40-pound lots, a a special service to staff physicians who desire U. S. P. grade of milk of magnesia can be pro- to use formulas which do not compare in compoduced at a total ingredient cost of not more than sition to those supplied by the pharmaceutical 15 cents a gallon. The necessary equipment is a concerns. For various reasons the physician high-speed mixer of at least one-gallon capacity. may also desire a modification of a U. S. P. or Final treatment with a colloid mill or homogen- N. F. formula. In other words, the physician is izer is optional. For those using a considerable not limited to what is available on the market. amount of aluminum hydroxide gel, a quality Most physicians are always on the alert for better product can be produced by adding water to a forms of medication and it is here that the pharconcentrate at an intredient cost of about eight macist is in a position to develop new formulas for cents a pint. Using the precipitation process the physicians which will enhance his prestige (aluminum sulfate and sodium carbonate), the as a pharmacist and improve the medications. Featuring the arguments of economy and servgel may be produced in any quantity at about the same ingredient cost but with a higher labor ice to the hospital, backed up by investigation of cost. Formulas are available for the addition hospital pharmacies where manufacturing is of magnesiilm trisilicate, kaolin or mineral oil to conducted, the hospital pharmacist should be the gel. A high-speed mixer is required for the able to convince the administration that the eshydration process and also a colloid mill or homo- tablishment of a manufacturing unit is worthy genizer (a colloid mill preferred) for either process. of consideration.
364
JOURNAL OF THE AMERICAN PHARMACEUTICAL ASSOCIATION
ANNOU THE UNION OF TWO GREAT
NEO-SYNEPHRINE SULFATHIAZOLATE for topical treatment of colds and sinusitis-is available in i-oz. (with dropper) and i6-oz. bottles as a 0.6 per cent solution in a buffired, approximately isotonic vehicle.
365
PRACTICAL PHARMACY EDITION
NC ING THERAPEUTIC AGENTS
N eo-S¥neRhrine Sulfathiazolate combines powerful vasoconstriction and potent bacteriostasis in one stable chemical compound In response to widespread demand, Stearns research has linked into one stable chemical compound the unique advantages of the outstanding vasoconstrictor N eo-Synephrine Hydrochloride, and the equally well-known qualities of sulfathiazole. And this combination has been effected without diminishing the therapeutic value of either agent, and without sacrificing safety. Vasoconstriction is fast, prolonged and without appreciable cardiac or psychic reaction or local irritation - and bacteriostasis is equivalent to that of
Fredenck
sodium sulfathiazole-an ideal combination for dual-action treatment of colds and sinusitis. Now being introduced to physicians through one of the most intensive advertising and detailing programs ever put behind a new professional product, Neo-Synephrine Sulfathiazolate is obviously a product of tremendous potential as a big, steady profitmaker. Check your stock . . . note your needs . . . and order today.
Stearns
& Company
Since 1855 ... ESSENTIALS OF THE PHYSICIAN'S ARMAMENTARIUM NEW YORK
KANSAS CITY
DETROIT, MICH.
SYDNEY, AUSTRALIA
SAN FRANCISCO
AUCKLAND, NEW ZEALAND
WINDSOR, ONTARIO