Oral formulations
Karen Anne Gunnell, Rebecca Hayley Venables in A Practical Guide to Medicines Administration, 2018
(Adaption based on review of patient information leaflets)6,10,11Ask the patient to make sure their mouth is moist with either their saliva or a drink of water.Using dry hands, advise the patient to place the buccal tablet between the gum and upper lip. The tablet needs to be positioned high up on the top gum. This can be placed on either side of the mouth. (See Figure 1.3.)If the upper gum is not a comfortable position for the patient, e.g. due to wearing dentures, then the buccal tablet can be placed in any position between the gum and lip.As the tablet begins to dissolve, it will soften and stick to the gum. Advise the patient not to chew or swallow the tablet, as it will need to completely dissolve and be absorbed through the buccal lining.Advise the patient that they should not move the tablet with their tongue, as this will affect the rate at which it dissolves.Inform the patient that it is advisable not to eat, drink, smoke or rinse their mouth whilst the tablet is dissolving and for a short period afterwards.
Amoxicillin–Clavulanic Acid
M. Lindsay Grayson, Sara E. Cosgrove, Suzanne M. Crowe, M. Lindsay Grayson, William Hope, James S. McCarthy, John Mills, Johan W. Mouton, David L. Paterson in Kucers’ The Use of Antibiotics, 2017
There are insufficient data to determine optimal oral dosing regimens in newborns and infants less than 2–3 months of age. Children > 40 kg in weight can generally be administered adult recommended doses. The 250-mg/125-mg chewable tablet and the extended-release 1000-mg/62.5-mg formulation are not recommended in children younger than 12 and 16 years of age, respectively. Dosing recommendations vary somewhat with the different pediatric formulations. With the early amoxicillin/clavulanic acid suspensions in a 4:1 ratio, daily doses of amoxicillin–clavulanic acid of 25–50 mg/kg/day administered in three divided doses was recommended (Dambro et al., 1984; Gooch et al., 1984), increasing to 50–75 mg/kg/day of amoxicillin–clavulanic acid (40–60 mg amoxicillin plus 10–15 mg clavulanic acid) for more serious infections (Nelson et al., 1982; Schaad et al., 1986). Some authors have used higher doses for serious infections (120 mg/30 mg/kg/day) in three divided doses (Dagan and Bar-David, 1989). Twice-daily amoxicillin–clavulanic acid 50 mg/12.5 mg/kg was satisfactory for treatment of children with acute otitis media (Jacobsson et al., 1993).
Statistical Methods for Assessment of Complex Generic Drugs
Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow in Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
A total of 48 subjects were included in the analysis of study 1, and 144 subjects were included study 2. Results for bioequivalence analysis are shown in Table 9.2. Although the 90%CI of the relative bioavailability (F) of study 1, 0.73–1.28, was wider than the BE limits of 0.80–1.25, the point estimate of F, 0.996, still shown a very similar PD activity between orlistat 27-mg chewable tablet and 60-mg capsule. Study 2 increased the sample size and yield a relative bioavailability of 1.094 and 90%CI of 0.978–1.215 using dose-scale method, which fell within the bioequivalence limits. Therefore, it could be concluded that 27-mg orlistat chewable tablet is bioequivalent to 60-mg capsule based on the results of these two studies.
Amphetamine extended-release oral suspension for attention-deficit/hyperactivity disorder
Published in Expert Review of Clinical Pharmacology, 2019
Ann C. Childress, Heather Chow
Initial AMPH and MPH oral formulations were immediate-release (IR) preparations that required multiple daily doses. Extended-release (ER) formulations allowed for the convenience of once-daily dosing, but the tablets or capsules were designed to be swallowed whole. For example, Osmotic-Controlled Release Oral Delivery System (OROS) MPH (Concerta) uses an osmotically active trilayer enclosed by a semipermeable membrane to allow for ER pharmacokinetics [8]. The United States Food and Drug Administration (US FDA) approved label directs the tablet to be swallowed whole and not chewed or crushed. A significant number of pediatric patients cannot swallow tablets and capsules. A recent prospective study of subjects aged 3 to 17 years found that 16% were not able to swallow any pill and another 25% were not able to swallow a size 0 capsule (closed length 21.6 mm) [9,10]. To address this problem, the capsules of several formulations can be opened and the contents can be sprinkled on applesauce [11–14]. The dosing instructions caution not to crush or chew the capsule contents. Breaking the ER beads in capsules may lead to dose dumping of the MPH or AMPH. To address safety concerns with the administration of ER products and provide a convenient alternative for patients, AMPH ER Oral Suspension or AMPH EROS (Dyanavel XR) was developed. This review will focus on the pharmacokinetics, safety, and efficacy of AMPH EROS.
Soft, chewable gelatin-based pharmaceutical oral formulations: a technical approach
Published in Pharmaceutical Development and Technology, 2018
Morten J. Dille, Magnus N. Hattrem, Kurt I. Draget
The use of gelatin can provide a solution to dysphagia issues as it has certain unique properties that can be used for the development of chewable oral drug formulations. For example, gelatin can be transformed into gels that have melting temperatures close to physiological temperatures. The prepared soft-chew formulation preserves ibuprofen in a suspended state arrested in the gelatin matrix of which the dissolution of both the delivery unit and ibuprofen will occur in the gastrointestinal tract. In Figure 3, the dissolution and disintegration profiles between the ibuprofen-soft-chew and a traditional ibuprofen tablet is shown. Only a small deviation was observed between the samples indicating that the ibuprofen-soft-chew formulation satisfies the demands with regards to immediate release (European Directorate for Quality of Medicines and Healthcare 2007; Nyol & Gupta 2013). However, in the first 10 min the dissolution rate of the soft-chew was faster compared with the traditional tablet, most likely due to a coating layer on the traditional tablet. The soft-chew formulation was prepared with a gelatin with a low Bloom value (150 g) that corresponds to faster melting kinetics compared with gelatins that have a higher Bloom value (Hattrem et al. 2014). These low-Bloom gelatin gels have very fast melting rates and are completely dissolved within 10 min at physiological temperatures of 37 °C (Hattrem et al. 2014). Therefore, it is suggested that in this soft chew formulation the rate-limiting step is the dissolution of ibuprofen itself.
Feasibility of developing hospital preparation by semisolid extrusion 3D printing: personalized amlodipine besylate chewable tablets
Published in Pharmaceutical Development and Technology, 2022
Xiaolu Han, Dongzhou Kang, Boshi Liu, Hui Zhang, Zengming Wang, Xiang Gao, Aiping Zheng
Chewable tablets are an immediate-release oral preparation that requires the patients to chew and swallow rather than swallow directly. Chewable tablets should be safe and easy to use in a diverse patient population, especially in children who are unable or unwilling to swallow intact tablets because of the size of the tablet or difficulty with swallowing. In the full factorial design, all formulations had the good printability, appearance, size, and thickness. The results of the full factorial design are shown in Table 4. The results were analyzed statistically, and the interactions of each independent variable with the dependent variable were evaluated.
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