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New Orodispersible Mini Tablets of Enalapril Maleate by Direct Compression for Pediatric Patients
- Source :
- Current Drug Delivery. 17:505-510
- Publication Year :
- 2020
- Publisher :
- Bentham Science Publishers Ltd., 2020.
-
Abstract
- Background: In many countries, hypertension in the pediatric population is considered a serious risk of mortality and morbidity. In this respect, it is central to design and develop new pharmaceutical forms for pediatric patients with hypertension. The development of Orodispersible Mini-Tablets (ODMTs) for pediatric use has gained importance in recent years. Therefore, regulations for developing suitable and palatable dosage forms for pediatric patients have been established by WHO authorities. Objective: This study aimed to design and develop orodispersible mini tablets of enalapril maleate (EnM ODMTs) for pediatric use. Methods: Five pharmaceutical formulations (A, B, C, D and E, shown in Table 1) were designed. The effects of different co-processed excipients and active pharmaceutical ingredients at different doses were studied. Lactose co-processed excipients selected were the following: Tablettose® 80, Microce- Lac® 100 and StarLac®. The micromeritic properties for all the physical mixtures were examined. The mini tablets were obtained by direct compression. Quality control parameters were determined in accordance with US Pharmacopeia. Results: Three OMDTs with StarLac® showed good results of hardness, flow ability and fast disintegration. The formulation with 0.1 mg of enalapril maleate presented the best results for the official parameters of hardness (4.0 kp), friability (< 1%), disintegration time (28 s), drug content uniformity (103.6 %), and wetting time (23 s). Conclusion: The three OMDTs with StarLac® showed good quality parameters, according to official requirements. Formulation A exhibited the best wetting time, complying with the dose recommended for pediatric patients. This formulation could be considered eligible for being manufactured at industrial scale.
- Subjects :
- Active ingredient
business.industry
Drug Compounding
Industrial scale
Administration, Oral
Pharmaceutical Science
Dentistry
Friability
030226 pharmacology & pharmacy
Dosage form
Mini tablets
03 medical and health sciences
0302 clinical medicine
Enalapril
Enalapril Maleate
030225 pediatrics
Humans
Medicine
Child
Control parameters
business
Antihypertensive Agents
Tablets
Pediatric population
Subjects
Details
- ISSN :
- 15672018
- Volume :
- 17
- Database :
- OpenAIRE
- Journal :
- Current Drug Delivery
- Accession number :
- edsair.doi.dedup.....fe94c866926446c4c5d004293a550c22