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Drug Development and Formulations Acessible 2
Drug Development and Formulations Acessible 2
FNFNMPC
Adult Nursing
Formulations
Pre-clinical studies
Approved drug
1
2.6
2.5
2
Billion ($)
1.5
1.2
1
0.802
0.5
0.318
0.231
0
1987 2000 2001 2006 2016
Data Source: http://csdd.tufts.edu/research-milestones
DD/Month/YYYY Professor/Dr: Topic title:
Pharmacology
• Patent for new drug: 20 years
• 10 years for development
• 10 years to sell
Patient
Illness
Comorbidities
Therapeutic Drug
Bioavailability Stability
Clinical efficacy Shelf life
Patient
Preference
Tablets
Compressed, multiple compressed, chewable, dispersible, sugar coated, film coated, gelatine coated
(Gelpcaps), buccal or sublingual, dispersible or effervescent, enteric coated.
Liquids
Monophasic (Solutions, Syrups, Elixirs, Linctuses). Polyphasic (Suspension, Emulsions Collodions)
Semi solid
Creams, gels Ointments, pastes
Inhalation
Patches
Aerosol
DD/Month/YYYY Professor/Dr: Topic title:
Medication = Active drug + Excipients
• Excipients:- constituents of the medication that are administered or taken by the patient other than the
active drug substance.
• Enteric coated tablets; ( have EN, EC or FC in their title) Leads to loss of stability of medication in stomach acid.
• Hormonal preparations (cytotoxic steroids) e.g. tamoxifen: can be absorbed by nurse administering the
medication and cause them harm
In addition to tablets already mentioned. Some tablets may crumble significantly on splitting
Helmy S (2015)
examined an selection of tablet, a number failed to split into equal half (in red).
• mirtazapine 30 mg, bromazepam 3 mg, oxcarbazepin 150 mg, sertraline 50 mg
• carvedilol 25 mg, bisoprolol fumarate 10 mg, losartan 50 mg, digoxin 0.25 mg, amiodarone HCl 200 mg
metformin HCl 1,000 mg, glimepiride 4 mg
• montelukast 10 mg, ibuprofen 600 mg, celecoxib 200 mg, meloxicam 15 mg
• sildenafil citrate 50 mg
Nidanapu et al. (2016) examined Phenytoin sodium [PHE], sodium valproate [SVA], carbamazepine, and
phenobarbitone in paediatric patients
1098 split tablet parts:-
539 (49.0 %) split parts were above the specified limit
253 split parts were outside the acceptable content uniformity range of <85 %
130 (72.2 %) patients (Paediatric) had plasma drug concentrations outside the therapeutic range
(PHE 36 [72.0 %], SVA 39 [78.0 %], carbamazepine 34 [68.0 %], phenobarbitone 21 [70.0 %]).
Abu-Geras et al (2017) examined use of hand and tablet splitter techniques to divide tablets.
88 Participants
Tablet splitter was more accurate
>25% scored small tablets did not divide into equal halves
41% of large unscored tablets broke into > 2 parts with a tablet splitter
Aoki et al., 2021 examined dispersion of cytotoxic Azothioprine when being split, they recommend that
(1) (1) AZA tablet splitting should be performed while wearing gloves,
(2) (2) the gloves should be changed before packaging the half tablets
(3) (3) the tools, packaging machines, and dispensing counters should be wiped twice or thrice with a water-
dampened cloth after dispensing.