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Responsibilities as an external consultant to a contract manufacturing organization (CMO)

Research in the field of medicine has contributed to changes in administration of dosage. Initially some administration routes for drugs are considered more convenient than other methods. However this relies and depends on the benefits and shortcomings of the drug administration route. The paper discusses on the possible and the convenient drug administration routes to apply in CMO. The paper also discusses on the methods to improve the physical stability and product chemical in the dosage for CMO

Routes of administration for biological medicinal products

Different routes of administration can be applied for biological medicinal products and generally for contract manufacturing organization (CMO). For instance, enteral, parenteral, and transdermal are the common broad routes of medicinal administration.

Hypodermoclysis administration route

Hypodermoclysis administration route is whereby the dosage is in fluid form and can be referred to as subcutaneous infusion or interstitial infusion. In this case, the dosage is normally in form of glucose or saline solution.

Advantages of Hypodermoclysis

Hypodermoclysis supports or allows for increased rate of drug intake when compared to intravenous infusion. Additionally, this method is cheap and effective. Hypodermoclysis also requires minimal supervision and can even be administered by non-medical personnel. This method is also considered safe since it does not pose serious complications and it is the most effective for the elderly.

Disadvantages of Hypodermoclysis

The major disadvantage of Hypodermoclysis route of drug administration is that it only supports or allows a capacity of 1ml per minute. In essence, it does not support administration of high volumes of dosage.

Transdermal route of administration

This entails the application of the dosage or drug directly to the skin surface and includes the administration of dosage to mucus membrane including lungs, nose, eyes, colon, vagina, and ears. The dose which is administered through this method includes gels, cream, transdermal patches, ointments, and suspensions (Neidle, 2008, p.133).

Advantages of the transdermal

The transdermal route of administration of doses results to less or no side effects. In addition, inhalation sprays through the nose can help in administering doses for curing systemic or local effects since absorption of the drug takes place through the skin (Troy, 2005, p.939). The other advantage is that this route of administration ensures that the blood vessels are stable. The transdermal route of administration also ensures that the first pass metabolism is avoided. An additional advantage of using the transdermal route of administration is that it ensures secure drug level into the system.

Disadvantages of transdermal route

There are cases of local therapeutic problems or effects once this method is used. The other disadvantage is that the dosage is not well absorbed in the lower or deeper skin layer or the mucous membrane. For the case of transdermal, the drug is required to be potent and failure of this might lead to the patch becoming too large.

Enteral

Enteral route of medicine cover a diversity of methods including oral, sublingual, buccal and rectal.

Oral route

Oral administration of medicine entails applying transdermally in the mouth and swallowing for absorption through the gastrointestinal track to system circulation (Kasapis, Norton, & Ubbink, 2009, p.603). Common forms of dose which can be administered using the oral route include liquids, tablets, capsules, syrup, solution, suspension, and elixirs.

Advantages of oral administration

The CMO can apply the oral route in administering medicine following its advantages as identified. Oral administration is convenient since it is pain free, self-administered, and easy when taking. The other advantage of oral administration is that absorption occurs along the entire GI tract length. In addition, oral administration is cheap compared to the other parental routes.

Disadvantages of oral administration route

CMO should also understand that oral administration route is bound to some shortcomings. In some cases, oral is considered inefficient since not all the drug is absorbed. Oral also has the disadvantage of effect of first pass which implies that drugs administered using this route pass through the portal vein to the liver. The oral administration route also leads to irritation of the gastric mucosa which eventually results to vomiting and nausea (Neidle, 2008, p.133). More often, the oral route is not recommended for emergency cases since it responds slowly and can not apply in cases where the patient is unconscious. Since some drugs have unpleasant taste, this administration route might be a challenge especially to young children. Digestive and gastric juices contribute towards destruction of the drugs.

Limb perfusion

Limb perfusion entails a medical technique which is generally applied in delivering anti-cancer dosage through the arm or leg. Blood flow is first stopped for a short duration using a tourniquet and the dosage is the administered directly to the blood in the limb.

Advantages of limb perfusion

Limb perfusion is the most effective method of drug administration in treating cancer. Additionally, limb perfusion ensures quick absorption of the administered drug (Limited, 2003, p.383). This method also ensures administration of high dosage compared to other methods.

Disadvantage of Limb perfusion

Initially, just like the other methods of drug administration, limb perfusion is associated with elevated risk which comprise of persisting impairment concerning the treated limb (Mahdi & Abolfazl, 2011, p.213). Another disadvantage of this method is that it is utilized in treating cancer but it can merely apply in treating other ailments.

The rectal route

This is whereby the drug is administered through enema or subsitory method. Some examples of rectal dosage include theophylline, chlorpromazine, and aspirin (Adikwu, & Esimone, 2009, p.1).

Advantages of rectal route

The rectal route administration of dosage can be used for cases involving children, it is also known to cause little, and in other cases no first pass effect (Adikwu, & Esimone, 2009, p.1). The other advantage of this method of administering dosage is that it works effectively for voting cases and lastly, this method is known to enhance high and rapid concentration.

Disadvantages of rectal route

Rectal route administration of dosage support erratic and slow absorptions. In addition, rectal mucosa suffers from inflammation and irritation once the rectal route s applied in administering dosage. This method of administering dosage is also not convenient.

Systemic-parenteral route

This is infusion or injection by the use of a catheter or a needle inserted into the body. In this case, the alimentary canal is the one used as the route of administration (Gillespie et al., 2010, p.830). Different types of injectables are used in this case including intramuscular, intravenous, subcutaneous, intra-arterial, intrathecal, intra-articular, and intradermal.

Advantages of parenteral route of administration

The route is convenient for cases where drugs administered orally are destroyed by secretions such as antibiotics and insulin. The route triggers a physiological reaction which may be useful in patient situations, for example, shock or heart attack. The method is convenient because it allows passage of medicines through injections, especially for stubborn patients. Parenteral route allows a patient to feed, in cases where the patient is unable to feed via the mouth.

Disadvantages of parenteral route

The paranteral consumes more time than other routes and also requires skilled persons. While using the route, conformance with various aseptic procedures is required. In addition, the patient cannot avoid the pain at the period of administration. The route is associated with physiological effects which are complex to reverse. The specifications for manufacturing and packaging for parenteral dosage states are expensive compared to other forms.

Advantages of intramuscular route

This administration route ensures uniform absorption. It also facilitates rapid onset of action (Gillespie et al., 2010, p.830). The other advantage of intravascular route is that it can be applied in cases of mild irritants and ensures that first pass is avoided. In addition, the intramuscular route of administration also ensures that gastric factors are avoided.

Disadvantages of intramuscular route

The drug dosage which can be administered using this method if limited to 10ml. local abscess and pain are also experienced when this administration route is applied. The other disadvantage of using this administration route is that it may lead to infection and nerve damage.

Advantages of Intravenous route

This administration route ensures that the desired concentration of blood is achieved. Moreover, it ensures administration of large quantity dosage and can useful in situations of diarrhea and vomiting (Staphylococcus aureus vaccine conjugate -- Nabi: Nabi-StaphVAX, StaphVAX' 2003, p.383). It is also suitable for emergency cases. Intravenous route ensures avoidance of the first pass and gastric manipulation.

Disadvantages of intravenous route

This administration route contributes towards cellulites and irritation. Moreover, it also poses some dangers of infection, expensive, painful, and less convenient (Neidle, 2008, p.133). The other disadvantage is that this administration route has less space and highly depends on technical assistance. It also leads to repetition in injections which are not always feasible as well as leading to thrombophelebitis.

The selection of the best route for CMO

The factors to consider when selecting the route for drug administration depend on the speed for absorption or drug release and the physical distinctiveness of the medicine. In addition,…[continue]

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