You have been asked to design an oral liquid formulation of ibuprofen for paediatric use. Discuss the issues which should be considered before embarking on the formulation design/manufacturing process. The issue that needs to be considered includes: Size and stability: Liquid formulation can be bulky, difficult to transport and store.1 During storage under the stated conditions, it’s necessary that oral solutions are not subject to precipitation, fast sedimentation, caking or formation of lump.2 They have poor stability compare to solid dosage form formulation due to hydrolysis.1 Therefore, it’s important to optimize the active ingredient stability in liquid formulation including those prepared from powder or granules.2 Safety issues: Liquid formulation can be a preferred media for the growth …show more content…
Your department is currently working on a drug substance that will be formulated as a solid dosage product. Discuss the possible drug and excipient-related constrains of the formulation (no identity of the drug was given to you at this
However, low HLB surfactants may also be an important component of oral lipid-based formulation by behaving as a coupling agent for the high HLB surfactants and the lipophilic solvent components, as well as contributing to solubilization by remaining associated with the lipophilic solvent post-dispersion. Moreover, using a blend of high and low HLB surfactants may also lead to more rapid dispersion and finer emulsion droplet size upon addition to an aqueous phase [36, 48, 49, 51–55]. Thus, in this study, we decided to mix Tween 80 (high HLB value) with Carbitol (low HLB value) to identify the most effective combination emulsifying with three chosen oils. The size of the emulsion droplets decreased as the HLB value of surfactant mixture reached the required HLB (Table 2). In the case of soybean oil, the smallest size was 277 ± 2.49 nm obtained at 20:80 (v/v) ratio of Tween 80:Carbitol). In the cases of ethyl oleate (Tween 80:Carbitol, 90:10, v/v) and IPM (Tween 80:Carbitol, 60:40), the smallest droplet sizes were 2.9 ± 0.170 and 10.5 ± 0.596 nm, respectively. These results show that the combination of Tween 80 and Carbitol had extremely good emulsifying ability, resulting in a fine emulsion in the cases of using ethyl oleate and IPM oil. The results of the visual test (Fig. 1) are parallel to the results of droplet size measurements. The combinations that had a smaller droplet size of 100
...lsion had only come apart 2.5 mL. Listing them best to worst helped come up with the idea of putting together the two best ingredients in an emulsion. Whey Protein Concentrate did completely destabilize but it took all fifteen minutes to do so. Combining the two ingredients stabilized the emulsion the best because it stayed stable for all fifteen minutes.
this drug as a "schedule I" drug that means that it has high potential for abuse.
a drug gets the CDER approval, the drug is on the market as soon as the firm gets its production
Precision of a patient’s intravenous medication is essential; it must be safe from. contamination, toxicity, and side effects. Most people believe these medications are compounded or mixed by a trained and licensed individual. However, this is inaccurate because the pharmacy technician actually compounds a large percentage of a patient’s medications. Compounding involves a technician’s math skills, aseptic technique, and professional ethics.... ...
This service is experienced, documented, evaluated and paid for as Pharmaceutical Care. Pharmaceutical Care consists of a philosophy of practice, patient care process as well as a patient management system. Pharmaceutical Care has common integrated vocabulary consistent with other patient care practices such as medicine, dentistry and nursing. Philosophy of pharmaceutical care consists of a description of the social need for the practice, a concise and clear statement of individual practitioner responsibilities to meet this social need, the expectation to be patient-centered and the requirement to function within the caring paradigm. This philosophy of practice is expected and practiced by all health care professionals. The patient care processes must be consistent with the patient care processes of all other health care providers. These processes include the assessment of the client’s pharmaceutical needs, a health care plan that is constructed to meet the specific needs of the client and a process in which evaluates the health care plan to gauge the efficacy of decisions made and actions taken. Pharmaceutical care management system includes all resources needed to manage the client’s needs, which include the space provided, such as a clinic or hospital, an appointment system for patients, appropriate and ethical documentation, reporting of patient care, evaluation of decisions made and actions taken and payment of service
candidate for a new designed drug, I am going to use a special computer program called
Potent pain medication contains the aspects of utilizing medications such as morphine or demerol, how the medications are dispensed, and t...
Solubility is based on the highest-dose strength of an immediate release product. A drug is considered highly soluble when the highest dose strength is soluble in 250 mL or less of aqueous media over the pH range of 1 to 7.5. The volume estimate of 250 mL is derived from typical bioequivalence study protocols that prescribe administration of a drug product to fasting human volunteers with a glass of water. A drug substance is considered highly permeable when the extent of intestinal absorption is determined to be 90% or higher. Otherwise, the drug substance is considered to be poorly permeable. (Yu et al., 2002)
In this lab, Thin Layer Chromatography was used to identify the components of a certain drug. To do this, the compound in question, Motrin was tested against six standards in three different solvents. The three solvent were hexanes, ethyl acetate, and 75% ethyl acetate and 25% hexane; the solution of 75% ethyl acetate and 25% hexane was determined to be the best solvent. This is due to the larger variance in RF values. The six standards that Motrin was tested against were Aspirin, ibuprofen, acetaminophen, naproxen sodium, caffeine and a caffeine and ibuprofen mixture. To determine which standard was present in the chosen drug, the retention factors, or RF, were calculated. A UV light was also used to see the distance each sample traveled in
Medications very often are kept in unlabeled containers which are difficult to identify. This goal attempts to deal with this unsafe practice which neglects basic principles of safe medication management
salmeterol, I want to optimize this drug to make it better by giving it different analogs,
To continue, compounding would be needed if a patient wants to change something about the medicine such as flavor or strength. It is vital that s...
Purpose: The purpose of this report is to describe the Food and Drug Administration’s (FDA) administrative process, describe how FDA powers are limited, and to provide an overview of the FDA’s premarket review process for drugs, biologics, and medical devices. I. Brief Introduction of Administrative Agencies and the FDA The FDA and other federal administrative agencies are created from and derive their powers from laws passed by Congress, and Congress derives the power to create administrative agencies from Article I, Section 8, of the U.S. Constitution. Passed in 1906 by Congress, the Pure Food and Drug Act prohibited interstate commerce of adulterated and misbranded food and drugs, and established the Bureau of Chemistry which later became