Table A5.
Liquid formulations for paediatric use in Research Articles.
| Formula | Pharmaceutical Form | Excipients | Active Principle (Dose) | Age | Stability (Stability in Use) |
References |
|---|---|---|---|---|---|---|
| Organic solvent-based formulation of lorazepam (Oral Solution) | Oral solution | PEG 400 (10% v/v), Propylene glycol (3% m/v), Glycerol (87% v/v) and Orange essence (0.1%) | Lorazepam (1 mg/mL) | Children 1 month to 12 years old | 12 months at 4 °C (Stability in use: 4 weeks) |
[119] |
| Oral solution of amlodipine besylate for children | Oral solution | Sucrose jarabe (32% m/v), Methylparaben (solution 15% m/v) (0.3% m/v) and Purified water (75%) | Amlodipine Besylate (0.5 mg/mL) | Paediatric Population (children and teenagers) | 12 months at 4 °C (Stability in use: 18 weeks) |
[120] |
| Oral tizanidine hydrochloride, Formulation for hospital use |
Oral solution | CMC (carboxymethyl cellulose) (0.5%), Potassic sorbate (0.15%), Sucralose (0.10%), Citric acid and Purified water | Tizanidine Hydrochloride (1 g/mL) | Paediatric Population | 70 days at 15–30 °C, 2–8 °C and 40 °C | [121] |
| Paediatric oral formulation of clonidine hydrochloride | Oral solution | Sucrose syrup (20% v/v), Raspberry essence (0.05%), Methyl paraben solution 15% (1% m/v), Citric acid monohydrate (1% m/v), Disodium hydrogen phosphate (1.8% m/v) and Purified water | Clonidine HCL (50 µg/mL) | Paediatric Population | 9 months at room temperature, protected from light | [122] |
| Oral liquid formulation of clonidine hydrochloride for paediatric patients | Oral solution | Potassic sorbate, Sucrose and Monohydrate citric acid | Clonidine hydrochloride (20 µg/mL) | Paediatric Patients (all ages) | 90 days at 5 °C (cooling) (Stability in use: 42 days at 5 °C) | [123] |
| Paediatric oral formulations of sodium dichloroacetate | Oral solution | Vehicle Mascagni (% w/v): Sucralose (0.02%), Hydroxyethyl cellulose (0.2%), Citric acid (0.09%), Sodium citrate (0.09%) and Potassium sorbate (0.18%) | Sodium dichloroacetate (DCA) (9.5% w/v) | Paediatric Patients | 3 months at 4 °C and 25 °C (Stability in use: 1 month to 4 °C) | [124] |
| Furosemide solutions for personalized paediatric administration | Oral solution (extemporaneous) | Solution I: Buffer carbonate-bicarbonate (pH) (10 mL) Excipient for syrup (cps 100 mL) (ACOFARMA): sucrose, water, sorbitol, glycerine, aroma, citric acid, methyl paraben, potassium sorbate, sodium phosphate and colorant. Solution II: Buffer carbonate-bicarbonate (pH) (10 mL) -Excipient for syrup—without sugars (cps 100 mL) (ACOFARMA): sodium saccharine, xanthan gum, water, sorbitol, glycerine, aroma, citric acid, sodium citrate, methyl paraben, propyl paraben, potassium sorbate, sodium phosphate and colorant. |
Furosemide (2 mg/mL) | Paediatrics | 60 days at 4 and 25 °C | [125] |
| Formulation comprising acetaminophen, especially for paediatrics (PATENT) | Oral solution (nano-emulsion) | NF glyceryl mono linoleate (5–30%, preferably 8-26% w/v), PEG-35 castor oil (30–60%, preferably 39–46% w/v), NF diethylene glycol mono ethyl ether (20–45%, preferably 24–40% w/v) and Water | Paracetamol (5–18% w/v) | Paediatrics | NA | [126] |
| Paediatric formulations of ursodeoxycholic acid from oral administration | Oral suspension | Glycerol (20%), Methyl cellulose 1000 (1% v/v) and Purified water | Ursodeoxycholic acid (UDCA) (1.5 mg/mL) | Paediatric Population | 30 days at 25 °C or in fridge | [127] |
| Oral paediatric formulation of hydrochlorothiazide | Oral suspension | Glycerol (20%), Methyl cellulose 1000 (1% v/v), Citric acid (pH corrector) and Water | Hydrochlorothiazide (2 mg/mL) | Paediatric Population in general | 3 weeks at 5 °C and protected from light | [128] |
| Oral suspension of clindamycin HCL with ion exchange resin for paediatric use | Oral suspension | Glycerine (30% w/v), Sucralose (3%), Aroma of maple syrup (7%), Grape aroma (10%), Cremophor RH 40 (15%), Xanthan gum (0.2%) and Deionized water (cps 5 mL) | Clindamycin HCL resin (Amberlite IRP 69) (5.5% w/v) | Paediatric Population | 1 month at 25 °C | [129,130] |
| Isoniazid suspension formulated with cationic resin for paediatric use | Oral suspension | Sorbitol solution 70% USP (4.9 mL/ 5 mL), USP monohydrate citric acid (50 mg/5 mL) and USP potassic sorbate (5 mg/5 mL) | Isoniazid resin/Kyron T-134 100 mg/5 mL/200 mg/5 mL |
Paediatric Population | 3 months at 40 °C (accelerated stability study) | [131] |
| Paediatric xylometazoline nasal spray formulation | Nasal Spray | Sodium colatum (105 mg/10 mL), PEG 400 (1.35 mL/10 mL), Sodium carboxy methyl cellulose (10 mg/10 mL), Glycerine (0.15 mL/10 mL), Methyl paraben (3.3 mg/10 mL), Sodium chloride and Purified water (cps 10 mL) | Xylometazoline HCl (5 mg/10 mL) |
Paediatric Population | 12 months at 25 °C | [132] |