Abstract
Co-Processed Excipient (CPE) is technological innovation for tablet preparation through the direct compression method with a quick and straightforward manufacturing process. This research aimed to formulate and evaluate tablets prepared via a spray drying method with CPE used to improve the compressibility and flowability of formulations containing chlorpheniramine maleate. The spray dried CPE containing MCC PH 101, and Kollidon ® K30 was made into tablets through a direct compression method. Meanwhile, Ludipress ® and Avicel ® PH 102 were used as filler-binder comparators. All the prepared tablet formulations were then evaluated for weight variation, hardness, friability, disintegration time, content uniformity of active ingredient, and dissolution test. The physical properties of tablets with CPE as a filler and binder produced an average weight of 151.65 ± 1.53 mg, 5.92 ± 0.38 kg of hardness, 0.06 ± 0.051% friability, 520.00 ± 2.00 seconds of disintegration time, and 99.24 ± 0.15% content uniformity of active ingredient. The comparators indicated better disintegration time than CPE, while the dissolution test showed that more than 80% (Q) of the amount of active ingredient was dissolved in 30 minutes.CPE could be successfully used to prepare tablet dosage form, and the tablets had fulfilled the standards of pharmacopoeia.
Highlights
As the most widely used dosage form, oral administration, including tablets, in particular, accounts for 70-80% of any pharmaceutical preparations mainly because of its manufacturing simplicity, dose accuracy, and high level of patient compliance (Syukri et al, 2015)
The findings showed that spray-dried MCC PH 101, lactose, and Kollidon® K30 could serve as an alternative filler and binder in a direct compression process, but the best Co-Processed Excipient (CPE) consisted of MCC PH 101 and Kollidon® K30 only
Company Indonesia, Kollidon® K30 was the product of Hangzhou Nanhang, and microcrystalline cellulose (MCC PH 101) and Avicel® PH 102 came from Asahi Kasei Chemicals
Summary
As the most widely used dosage form, oral administration, including tablets, in particular, accounts for 70-80% of any pharmaceutical preparations mainly because of its manufacturing simplicity, dose accuracy, and high level of patient compliance (Syukri et al, 2015). Despite the well-known significance of excipients for the success of pharmaceutical products, there has been only a minor development of new excipients. They are rarely introduced to the market probably because discovering novel excipients is challenging or due to the modest profit. The poor mechanical properties of active ingredients in a high dose make tabletting difficulty in tablet production, mostly forcing formulators to apply granulation techniques that provide appropriate compression properties of drug-excipient agglomerates. The basic DC process has even been successfully simplified by the innovative development of co-processed excipients (Aljaberi et al, 2013)
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