Reasons To Consider In Establishing Large Volume Parenteral Solution Micro - Facility

Today I would like to talk about a technology for producing Large Volume Parenteral Solutions (LVPS) Micro-Facility described elsewhere in accompanying materials, a "turn-key", modular, pre-fabricated, production plant meeting the criteria to produce LVPs of United States Pharmacopoeia quality and according to the United States Good Manufacturing Practices as stated in 21 CFR Part 211 and USP No. XXIV. (U-FDA Guidelines) intravenous solution manufacture or any other Regulatory Agency. The United States has a population in excess of 330,000,000 and is in a cardinal position, located in a strategic geographical area.

The United States has four (4) basic categories of health care facilities: The Federal Government owns and operates 285 Hospitals with a 62,000 bed count. The State and Local Government own and operate 1,260 Hospitals with a 148,000 bed count. Non-Profit Hospitals (normally religious organized and affiliated hospitals) operate 3000 hospitals with a bed count of 591,000, and investor owned hospitals number 797 with a bed count of 115,000. This montage of institutions represent a plethora of hospitals well under 200 beds, however, there are a few, which are deemed to be "larger hospitals. These large institutions are usually affiliated with a university or government hospitals. In the Unites States the population is clustered around various metropolitan areas. The number of units of intravenous solutions consumed in the United States exceeds 1,132,000,000+ units per year, and this is a conservative number as it is believed to be closer to 1,300,000,000 units. The United States healthcare level status is on the average about four (4) units of IV solutions for every man, woman and child. IV solutions are used in a number of places other than hospitals, for example, clinics, homes, health centers, etc. For instance, the Home Health Care market in The United States is at a high level, mature and a sophisticated market is currently increasing at the rate of 18% per year.

The number of units that are utilized per hospital can be estimated based upon the statistical information available. Currently are sourced from various distribution points established by companies that are in the distribution business (not manufacturing) in the United States. Ancillary products used in conjunction with intravenous solution are generally sourced from other manufacturing facilities. The consumption of LVPs is approximately 4+ per person in the Unites States. On a per-hospital bed basis/per day census, are consumed at the rate of 4.5 units per bed/per day census in tertiary care hospitals. General hospitals consume approximately 2.5 units per occupied bed per day. Consequently, the total annual market is deemed to be a considerable amount in number of units.

The economy of producing locally with the Intravenous Solution Manufacturing Facility is important for five considerations: A) The cost to produce is lower than to buy the product manufactured in locations where long distance freight expense is incurred B) Conserving local capital, better used for other purposes and purchasing from indigenous industry C) Social need to employ labor and to develop personnel from the local economy through technological training D) Use of the abundant resources (why pay for raw materials outside the local area as finished products when they can be available locally E) Exportation opportunities of high-value pharmaceutical products. Each of these considerations has important economic impacts, albeit, both quantitative and qualitative Each of these considerations have important economic impacts, albeit, both quantities and qualitative.

The demand for the product outside the local economy must be adequate to support an export market. The rudimentary nature and the lack of it in adjacent countries support an important aspect of the economic potential of LVPs. Any country, specifically second world countries, can be in a cardinal position to develop its indigenous industry out of its own economic needs and to expand its stabilized technology for export to other countries and all regions of the world. The corollary factor to export is quality of the product and their marketability. The technology section addresses the superior quality of the Intravenous Solution Manufacturing Facility products. Made within this technology exceed the current standards of the United States Pharmacopoeia (USP), and the United States Food and Drug administration (US-FDA) and any other world standards. The facility produces products which can be introduced into any area of the world. Finally, the price of the product is an important characteristic enabling its exportation. The capacity to produce the product at a fraction of their current market price indicates a vast export potential. Competitive pricing together with demand and quality suggests an excellent export industry. The export market holds no barrier to quality and quantity of US-FDA quality LVPs.

US-FDA quality LVPs The export market stands in a crucial position for any country to address the needs of the world because certain areas are poorly served, and in some areas the requirements are unmet. Any country has the potential availability of all of the basic raw materials within its own economy and can trade with all markets. The conclusions derived from the above cited use rates per population and the current prevailing prices are no different from other markets with which the US can serve and are adequate incentives to target production for export. The strategy to place as early as possible an Intravenous Solution Manufacturing Facility in any country to accommodate both domestic and export demands provide the investor- buyer with a profitable earning capacity, with a relatively low capital investment to earnings ratio. The cost of an US-FDA quality product made specifically with this technology would be paid back not only by profits generated in the home market but also on its capacity to generate profit on export sales.

This Micro-Facility has the capability of producing a wide array of parenteral pharmaceuticals. The primary product line of the intravenous solution which contain water for injection and low concentrates of carbohydrates and salts, such as, dextrose, potassium chloride, sodium chloride, sodium lactate, and which container may be finished as a plastic bag in various sizes or as a rigid plastic bottle for irrigation or "pouring" solutions.

The Appendix contains a typical list of products which are those used as often as 90% of the time in medically developed countries. The above products may have added to them other medications for which they have markets in hospitals. Examples of such products are: antibiotic drugs used to provide a ready-compounded product ready to administer to the patient and amino acids to provide products for the total parenteral nutrition of patients. These products accommodate the growing sophistication of medical care in the hospital market. The need arises out of pure level of care which is driven by physicians who remain apprised in medical advances in other countries, primarily in Europe and the USA and then demand these services and products in their local practices.

The specialty parenteral products are non-proprietary in nature but are commonly required in tertiary care hospitals or in advanced disease states of patients. Custom parental products are sought by two major types of contractors: · the major pharmaceutical manufacture who lacks the capability to produce parenteral products · innovators who need a parenteral product of a proprietary drug in clinical investigation The capacity of this Micro-Facility, to address a broader market than LVPs alone, is an economic advantages few 17 medically developing countries process. The profit potential in the secondary products out-performs that of the primary products. While these markets have to be developed within the USA, EU or any other country, the early engagements of these secondary markets provide the means to expand production facilities at little risk and to widen profit margins.

The technology is dependent upon adequate, well prepared and trained personnel. While the personnel requirements of this technology transfer is few in number, the Micro-Facility presents an initial building-block in the establishment of parenteral drug production in the country and among their trading partners. Without capacity to produce pyrogen-free sterile water the production of all manner of parenteral drugs is neither permissible nor possible. The introduction of the employment opportunity to produce intravenous solutions conserves important talent which would find employment, possible beyond their country's borders.

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