Pharmaceutical Studies on Formulation and Evaluation of Sustained Release Tablets Containing Certain Drugs

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1 Mansoura University Faculty of Pharmacy Department of Pharmaceutics Pharmaceutical Studies on Formulation and Evaluation of Sustained Release Tablets Containing Certain Drugs Thesis presented by Ali Saeed Owayez B. Pharm. Sc. Baghdad University (1999) Submitted in Partial Fulfillment for the Master Degree in Pharmaceutical Sciences (Pharmaceutics) Ass. Prof. Dr. Galal Mahmoud Abd El-ghany Associate Professor of Pharmaceutics Faculty of Pharmacy, Mansoura University Under the Supervision of Ass. Prof. Dr. Irhan Ibrahim Abu Hashim Associate Professor of Pharmaceutics Faculty of Pharmacy, Mansoura University 2017

2 The use of sustained-release technology in the formulation of pharmaceutical products has become increasingly important in the past few years and many efforts have been made toward achieving sustained release formulations of large number of drugs. Matrix tablets are common sustained and/or controlled release dosage forms due to their apparent simplicity of formulation and production. Matrix systems comprise drug/excipient embedded within a matrix, in which retardant materials are employed for the preparation of matrix tablet formulations. They can be classified as either water insoluble inert materials (polyethylene, polyvinyl chloride, methyl acrylate, methacrylate copolymer, and ethyl cellulose), Insoluble, erodible materials (stearyl alcohol, stearic acid, polyethylene glycol, carnauba wax, caster wax, polyethylene glycol monostearate, and triglycerides), hydrophillic materials (hydroxy propyl methylcellulose, sodium carboxy methylcellulose, methylcellulose, hydroxy ethylcellulose, galactomannose (guargum), chitosan, gum acacia, locust bean gum, sodium alginate, karaya gum, pectins, and xanthan gum), or natural polymers (ispaghula husk, and tamarind seed polymer). Sustained release matrix tablets were prepared by direct compression technique. The formulation of atenolol and terbutaline sulphate in sustained release matrix tablets were the aim of this study. The thesis was divided into four parts. Part I Formulation and Evaluation of Sustained Release Matrix Tablets of Atenolol The objective of this part was to develop a sustained release tablet formulations of Atenolol by employing different percent polymer (Kollidon SR (KSR)) (20, 30, 40, and 49%), with different types of diluents (spray dried lactose (SP.D.L), Avicel PH101 (AV), or Emcompress (EMS)) by direct compression technique. Flow properties and compressibility were studied for the powder of the prepared tablets. The possibility of interaction of drug with the utilized pharmaceutical excipients was investigated using Fourier transform infrared spectroscopy (FT-IR) and differential scanning calorimetry (DSC). The prepared tablets were evaluated for various parameters including weight variation, thickness, friability, hardness, and disintegration time (D.T). In vitro drug release study was carried out using different media (0.1N HCl ph 1.2, Phosphate buffer ph 7.2, and Distilled water (DW)). VII

3 The obtained results for the prepared atenolol tablets and physical mixtures were as follows: 1- The flowability of formulae that had a sustained release property (30 and 40% KSR) was ranged between Fair to good flowability. 2- The FT-IR spectra of physical mixtures of the drug:ksr mixed with SP.D.L, AV, or EMS showed the characteristic peaks of drug, KSR and each compound. These results indicated that the drug did not interact with any of the added excipients suggesting good compatibility of the drug and the excipients. 3- The DSC thermograms showed no interaction in between the drug and each of the excipients used in physical mixtures. 4- The thickness results obtained within each formula was directly proportional and parallel to that of weight and comply with the allowable limit ± 5% of the average value. 5- All the formulae (except F10) exhibited friability percent values lower than 1%, thus comply with the USP 30-NF 25 Pharmacopoeia requirements. 6- All the prepared formulae (except F10) have acceptable hardness which increased as the concentration of KSR increased. 7- Increasing the compression force (CF) had no effect on the weight variation, friability, hardness, or D.T. 8- The time taken for disintegration was increased as the KSR concentration was increased, where the D.T. increased from 36.0±1.00 min to >360 min. upon increasing the percent of KSR from 20 (F2) to 40% (F4). Also, the sequence of D.T. of the prepared tablets containing different fillers were in the following order SP.D.L<AV<EMS. Upon using different disintegration media, the fastest D.T. was observed in 0.1N HCl ph 1.2> phosphate buffer ph 7.2>DW. 9- Release rate studies on atenolol tablets showed that the amount of drug released was decreased with the increase of KSR concentration, as the percent of KSR increased from 0% (F1) to 40% (F4), the drug release rate in DW was decreased from 100% after 3 h to 36% after 6 h, respectively. On comparing the effect of different fillers on the release of drug, it was found that the release of drug from tablets containing various fillers can be ranked as follows: SP.D.L>AV>EMS. Increasing the percent of KSR in the tablets (from 30% to 40%) resulted in much slow drug release, and reach the arbitrary release rate (50% in 6 h). Also, the release rate of drug was faster in 0.1N HCl ph 1.2 in comparison to that in DW and phosphate buffer ph 7.2. VIII

4 10- There was no influence of high CF on the effect of different diluents used in the preparation of our formulae on the release profile. Formulae prepared with SP.D.L of high C.F. had an influence on the effect of KSR percent on the release profile in DW and 0.1N HCl ph 1.2, but not in phosphate buffer. Those containing AV had similar effect in each of DW and phosphate buffer ph 7.2 dissolution media, but different in 0.1N HCl ph 1.2 dissolution medium with the corresponding formulae of lower CF. Also, the same pattern was observed upon changing the filler to EMS in DW and phosphate buffer ph 7.2, but different in 0.1N HCl ph 1.2. Formulae prepared with SP.D.L of high C.F. had no influence on the effect of ph on the release of drug, but there were a difference in the release profile when using the fillers AV or EMS. 11- The kinetic mechanism of drug release from all previous formulations were best described to be controlled by higuchi model for most formulae. 12- The suitable sustained release of drug was obtained from tablets containing 40% KSR with each of spray dried lactose, avicel, or emcompress. Part II Formulation and Evaluation of Sustained Release Matrix Tablets of Terbutaline Sulphate This part deals with the study of terbutaline sulphate matrix tablets. The drug was formulated in sustained release tablets using KSR (40 and 60%) and various filler (SP.D.L, AV, and EMS). The FT-IR and DSC of terbutaline sulphate mixture with the formulation ingredients (KSR, SP.D.L, AV, or EMS) were studied to predict the interaction (if any) between the drug and additives. The formulated tablets were evaluated for mechanical and physical parameters including flow properties and compressibility, weight variation, thickness, friability, hardness, and disintegration time. Release properties were evaluated using different media (0.1N HCl ph 1.2, Phosphate buffer ph 7.2, and DW). The obtained results showed; 1- The flowability of formulae was ranged between Fair to excellent flowability. 2- The FT-IR and DSC demonstrated no interaction between terbutaline sulphate and the used formulation ingredients. 3- The thickness of the prepared tablets within each formula were nearly the same and parallel to their weight (as the weight increases, thickness increases), type of contents (formulae containing AV were thicker than others). IX

5 4- The loss in total weight of the tablets due to friability was less than 1% in all formulae (except F4, which was out of the range). 5- The hardness was affected by the type of diluent used and KSR concentration. In case of using AV in tablet formulae, the hardness was higher than other corresponding formulae. Formulae containing 40% KSR showed higher hardness compared with other formulae without KSR (0%). Further increase in concentration of KSR above 40% did not affect the hardness values. 6- The tablets containing 40 and 60% KSR did not disintegrate after 6 h, whereas the tablets prepared from physical mixtures containing SP.D.L disintegrated within min, that containing AV disintegrated within range of 51 min (in DW) to 189 mins (in 0.1N HCl ph 1.2), and that containing EMS disintegrated within 31 min (in 0.1N HCl ph 1.2) and not disintegrate after 6 h in other media (DW or phosphate buffer ph 7.2). 7- The percent drug released from the prepared tablets was affected by different fillers used, and resulted in excipient properties dependent drug release. The release rate of drug decreased upon increasing the KSR concentration. Further increase in KSR concentration above 40% did not significantly decreasing the rate of drug release from tablet formulations. When the concentration of KSR was 40% or above, the effect of ph of the media on the release profile of TBS was negligible.. 8- The kinetic mechanism of drug release from all previous formulations were best described to be controlled by higuchi model for most formulae. 9- The suitable sustained release of drug was obtained from tablets containing 40% KSR with each of AV or EMS. Part III Stability of Atenolol and Terbutaline Sulphate Matrix Tablet Formulations This part deals with the accelerated stability of formulae that gave the best sustained release of atenolol and terbutaline sulphate. The selected formulations were tested initially and at predetermined time intervals (1, 2, and 3 months) for their physical characteristics, and in vitro release profile which measured spectrophotometrically. The obtained results were as follows; 1- All the formulae stored at 40 o C/75% RH showed an increase in their weight with the increase in storage time. On the other hand, those stored at 30 o C/atmospheric RH were mostly not affected. 2- All formulae showed excellent uniformity of thickness. Formulae stored at 40 o C/75% RH showed an increase in their thickness after first month of storage, then kept in that X

6 range till the end of third month of storage. While formulae stored at 30 o C/atmospheric RH showed slight increase in their thickness. 3- Formulae stored at 40 o C/75% RH showed an increase in their hardness after first month storage, then kept in that range till the end of third month of storage. While those stored at 30 o C/atmospheric RH were mostly not affected. 4- The friability values were less than 1% indicating that formulated tablets were mechanically stable and in accordance with the USP 30-NF 25 pharmacopoeia requirements. It was noted that increasing the time of storage was associated with a less friability loss in tablet formulations especially at 40 o C/75% RH, while those stored at 30 o C/atmospheric RH were less variable and in accordance with their hardness. 5- The Disintegration time for all formulations was >360 min. Disintegration time was not affected by storage conditions. 6- In vitro release characteristics of AT tablets at 30 o C/atmospheric RH: It was found that there was no difference in the release profile of F4 (40% KSR, SP.D.L filler) in DW & phosphate buffer media during the overall three months at accelerated conditions, while fluctuation of the release profile of AT in 0.1N HCl ph 1.2 was observed during the whole time of storage. On the other hand, AT release from F13 (40% KSR, EMS filler) was not affected during the whole time of storage condition in all three media. 7- In vitro release characteristics of TBS tablets at 30 o C/atmospheric RH: There were no differences in the release profile in DW & phosphate buffer media during the overall storage conditions of the three months. In 0.1N HCl ph 1.2, the release profile was not different in 1 st month, whereas, there was a difference occurred in 2 nd month, after 3 rd month, the release of TBS returned to be similar with the initial one. 8- In vitro release characteristics of AT tablets at 40 o C/75% RH: It was found that the release of AT from formula F4 in 0.1N HCl ph 1.2 was different in all three months in relation to the initial one. In DW, the release profile of AT was not affected in the 1 st month, but different in 2 nd month, then returned to be parallel with the initial one after 3 rd month. In phosphate buffer ph 7.2, the release profile of AT was decreased after 1 st & 2 nd months, then returned to that of initial one after 3 rd month. In formula F13, the release of AT in 0.1N HCl ph 1.2 decreased in the three months in relation to the initial one. In DW, the change in the release profile of AT was shown in the 1 st month, then this profile returned to be parallel with the initial one after 2 nd & 3 rd month. XI

7 In phosphate buffer ph 7.2, the release profile of AT decreased after 1 st month, then this profile returned to be in accordance with the initial one after 2 nd & 3 rd month. 9- In vitro release characteristics of TBS tablets at 40 o C/75% RH: It was found that the release of TBS in 0.1N HCl ph 1.2 decreased in the 1 st month than initial, then returned to be similar to initial one after 2 nd month. Change was observed in the 3 rd month compared with the initial release profile. In DW, it was found that the release profile of TBS was not affected in the 1 st month. It decreased in 2 nd month compared with the initial one, then returned to be parallel with the initial one after 3 rd month. In phosphate buffer ph 7.2, the release profile of TBS was changed after 1 st month, then it returned to be not different with the initial one after 2 nd & 3 rd month. 10- It is recommended to protect tablets containing matrix of KSR from high temperature and humidity Part IV Bioavailability Study of Atenolol Matrix Tablets Containing KSR This part deals with the bioavailability in rabbits for two atenolol tablets formulations containing; 40% KSR with SP.D.L filler (formula A) which gave acceptable physical characteristic, best controlled drug release behavior and good stability, that was compared with formula containing SP.D.L filler without KSR (formula B) and commercial tablets (C). The bioequivalence of the formulations with that of the commercial tablets was assessed. The results of this part revealed that; 1- Atenolol tablets containing 40% KSR showed higher bioavailability and more efficient sustained-release effect than the control tablets. This indicated by high AUC value comparing to the control tablets. 2- The more suitability of KSR as a sustained-release polymer as indicated by increase in Tmax values. 3- The pharmacokinetic parameters (Cmax, Tmax, AUC, Ke, T1/2) of formulae containing 40% KSR were significantly different from those in the case of controlled or commercial tablets according to one way analysis of variance (ANOVA) followed by Tukey-multiple comparison test. XII

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