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1 59 e- ISSN Print ISSN International Journal of Biopharmaceutics Journal homepage: IJB FORMULATION AND EVALUATION OF PROMETHAZINE HCl FAST DISINTEGRATING SUBLINGUAL TABLETS Patil SV*, Derle DV, Wagh SB * Department of Pharmaceutics, N.D.M.V.P Samaj s College of Pharmacy, Gangapur Road, Nashik , Maharashtra, India. ABSTRACT This research work aims at developing fast disintegrating sublingual tablet of Promethazine HCl. Promethazine HCl which is an antiemetic agent is primarily used to treat the symptoms of motion sickness i.e. nausea and vomiting during travel or when in motion. The conventional tablet present in the market needs to be taken an hour before travelling, it undergoes extensive hepatic first pass metabolism up to 75% thereby reducing its bioavailability to 25%. Hence a 10mg fast disintegrating tablet was formulated by direct compression that can be administered sublingually to get rapid onset of action without any first pass metabolism. A total 9 batches (PF1-PF9) were formulated using three superdisintegrants viz. Crospovidone, L-HPC, and Kyron T-314 in three different concentrations. The tablets were prepared by direct compression technique. All the batches were evaluated for thickness, hardness, friability, weight variation, in vitro Disintegration time, in-vitro Dissolution time, % drug content, and content uniformity. The thickness of the batch from PF1-PF9 was found to be mm and hardness was found to be kg/cm 2 respectively. The friability, weight variation, and content uniformity were found to be within the specified IP limits. All the tablets were found to disintegrate within 50 secs with PF3 tablets disintegrating in 18 secs. The tablets showed in vitro release upto 100 % within 30 mins with PF3 showing release upto 96.05% within 10 mins. The drug content of all the nine formulations of Promethazine HCl tablets were found to be within the range of % and the average % drug content of tablets was found to be 99.52%. All the prepared formulations (PF1-PF9) were found to be stable after 150 days at the prescribed storage conditions as per ICH guidelines Q1A (R2) for Accelerated Stability testing. Key words: Promethazine HCl, Sublingual tablet, Superdisintegrants. INTRODUCTION Promethazine HCl is a phenothiazine, an H 1 - antagonist with anticholinergic, sedative, antiemetic effects and some local anaesthetic properties. It is used as an antiemetic to prevent motion sickness. Like other H1- antagonist, Promethazine competes with free histamine for binding at H1-receptor sites in the GI tract, uterus, large blood vessels and bronchial muscle. The relief of Corresponding Author Patil SV nausea appears to be related to central anticholinergic actions and may implicate activity on the medullary chemoreceptor trigger zone. The currently marketed dosage forms of promethazine HCl include conventional tablets, syrups and injections. The conventional medication has slow onset of action, needs to be taken 1 or 2 hours prior to travelling and has to be swallowed which requires water leading to incompliance with patients of motion sickness. The syrup dosage form has no precision over dose; high dosage may lead sedation, drowsiness. Injections have quick onset of action but lack patient compliance (Walton RP, 1935; Kurosaki Y et al., 1991; Ghosh TK et al., 2005).

2 60 Hence, developing a mouth dissolving solid dosage form which will give quick onset of action, no swallowing, no water intake, and no bitter taste problems etc will help to improve patient compliance in this perspective. Promethazine HCl is lipophilic drug freely soluble in water at ph 5-7. The pka value for Promethazine HCl is 9.1 and dose is mg for motion sickness. The sublingual administration of Promethazine HCl means placement of the drug beneath the tongue and drug reaches directly into the blood stream through the ventral surface of the tongue and floor of the mouth (Richman MD et al., 1965; Boer D et al., 1984; Al Ghananeem AM et al., 2006; Katz M and Barr M, 1955). MATERIALS AND METHODS All the materials used were of pharmaceutical grade. Promethazine HCl was provided as a gift sample by Ciron Drugs and Pharmaceuticals Ltd, Mumbai. Crospovidone NF, Talc, Sucralose, and Mg-Stearate were supplied by Glenmark Pharmaceuticals Ltd Nashik. Kyron T-314 and L-HPC were provided as gift samples by Corel Pharmachem, Ahmedabad and Arihant trading company, Mumbai Respectively. Mannitol DC was provided by Roquette Pharma Mumbai. Experimental methods Promethazine HCl fast disintegrating sublingual tablets were manufactured in nine formulations viz. PF1 to PF9. The total weight of each tablet was kept constant to 100 mg for all formulations. The drug and excipients were passed through #60 sieve. Weighed amount of drug and excipients were mixed in a polybag by geometric addition method for 20 minutes manually. The blend was then lubricated by further mixing with magnesium stearate (#60 sieve). The mixture blend was subjected to drying at C for 3 hrs, the mixture was blended with flavour and the powder blend was then compressed on 10 station rotary punching machine using round concave punches. Round punches using 6mm diameter were used for compression of tablets (Allen LV, 2003; The Drug Bank, 2006). Evaluation of Promethazine HCl sublingual tablets Drug-Excipient compatibility studies FT-IR spectroscopy was employed to ascertain the compatibility between Promethazine hydrochloride and the selected polymers. Potassium bromide, pure drug and the polymers (Super disintegrants) were heated to 105ºC for one hour to remove the moisture content if present in a hot air oven. Then in presence of IR lamp, potassium bromide was mixed with drug and/or polymer in 9:1 ratio and the spectra were taken. FT-IR spectrum of Promethazine HCl was compared with FT-IR spectra of polymers. Pre-compression parameters These include Angle of Repose, Bulk Density, Compressibility Index (Carr s Index), Hausner ratio etc. Post-compression parameters The tablets after punching of every batch were evaluated for in-process and finished product quality control tests i.e. thickness, weight uniformity test, hardness, friability, drug content, in vitro disintegration time, wetting time and in vitro drug release studies (British Pharmacopoeial Commission, 2009; The Indian Pharmacopoeia Commission, 2007). RESULTS AND DISCUSSION Drug-Excipient compatibility study Stretching cm -1, NH + stretching cm -1, aromatic C=C stretching cm -1, CH 3 and CH 2 bending cm-1, CH3 bending cm -1, C-N stretching of tertiary amine-1334 cm -1,

3 61 b. FTIR spectra of Promethazine HCl + Crospovidone (1:1) c. FTIR spectra of Promethazine HCl + Kyron T-314(1:1) d. FTIR spectra of Promethazine HCl + L-HPC (1:1)

4 62 Table 1. Composition of Promethazine HCl formulations PF1-PF9 F1-F9 Ingredients PF1 PF2 PF3 PF4 PF5 PF6 PF7 PF8 PF9 Sr No. 1 Promethazine HCl 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 2 Crospovidone 2.5 mg 5 mg 7.5 mg L-HPC mg 10 mg 15 mg Kyron T mg 5 mg 7.5 mg 4 Talc 1.0 mg 1.0 mg 1.0 mg 1.0 mg 1.0 mg 1.0 mg 1.0 mg 1.0 mg 1.0 mg 5 Sucralose 3 mg 3 mg 3 mg 3 mg 3 mg 3 mg 3 mg 3 mg 3 mg 6 Mg-Stearate 0.5 mg 0.5 mg 0.5 mg 0.5 mg 0.5 mg 0.5 mg 0.5 mg 0.5 mg 0.5 mg 7 Flavour 2 mg 2 mg 2 mg 2 mg 2 mg 2 mg 2 mg 2 mg 2 mg 8 Mannitol(q.s) 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg FTIR Interpretation of Promethazine HCl Table 2. Various peaks obtained in the IR spectrum of Promethazine HCl Sr no Wave number(cm-1) Vibration mode Peak obtained CH stretching NH+ stretching Aromatic C=C stretching CH3 & CH2 bending CH3 bending C-N stretching of tertiary amine Out of plane CH bending of disubstituted aromatic group FTIR Interpretation of physical mixtures of Promethazine HCl with Crospovidone, L-HPC, and Kyron T-314. Table 3. Various peaks obtained in the IR spectrum of Promethazine HCl with polymers Sr. no IR Spectrum Wave number(cm-1) Vibration mode Peak obtained 1 Physical mixture of Promethazine HCl + Crospovidone (1:1) 2 Physical mixture of Promethazine HCl + L-HPC (1:1) 3 Physical mixture of Promethazine HCl + Kyron T-314 (1:1) CH stretching NH+ stretching Aromatic C=C stretching CH3 & CH2 bending CH3 bending C-N stretching of tertiary amine Out of plane CH bending of disubstituted aromatic group CH stretching NH+ stretching Aromatic C=C stretching CH3 & CH2 bending CH3 bending C-N stretching of tertiary amine Out of plane CH bending of disubstituted aromatic group NH+ stretching Aromatic C=C stretching CH3 & CH2 bending CH3 bending C-N stretching of tertiary amine Out of plane CH bending of disubstituted aromatic group The principal peaks of Promethazine HCl were present in all the three FTIR spectras of crospovidone, L-HPC, and Kyron T- 314 with drug. This means that the above polymers do not interact with the drug and that the drug is compatible with these excipients.

5 63 Precompression parameters.table 4. Pre-compression parameters (values expressed as mean ± S.D where n=3) Formulation Bulk Tapped Angle of Hausners Carr s Index code density(g/cc) density(g/cc) repose(ө) ratio % LOD PF ± ± ± ± ± ±0.05 PF ± ± ± ± ± ±0.06 PF ± ± ± ± ± ±0.25 PF ± ± ± ± ± ±0.08 PF ± ± ± ± ± ±0.012 PF ± ± ± ± ± ±0.023 PF ± ± ± ± ± ±0.05 PF ± ± ± ± ± ±0.09 PF ± ± ± ± ± ±0.17 Table 5. Post-compression parameters (values expressed as mean ± S.D where n=3) Formulation code Thickness (mm) Hardness (Kg/cm 2 ) Friability (%) Weight variation (mg) Disintegration time (Sec) Wetting time (Sec) PF1 3.27± ± ± ±2.5 23±2.5 PF2 3.17± ± ±0.2 25±2.3 25±3.6 PF3 3.36± ± ±0.3 18±2.1 21±3.4 PF4 3.24± ± ± ±3.2 41±4.2 PF5 3.26± ± ±0.5 52±5.2 52±4.8 PF6 3.12± ± ±0.1 36±2.3 40±2.5 PF7 3.22± ± ±0.2 28±4.2 21±3.8 PF8 3.32± ± ±0.3 35±4.5 36±3.0 PF9 3.18± ± ±0.5 26±5.9 22±4.0 In vitro drug release profile Table 6. Dissolution profiles of PF1-PF9 Time % Cumulative drug release for all formulations (min) PF1 PF2 PF3 PF4 PF5 PF6 PF7 PF8 PF DISCUSSION In the present study, an attempt was made to develop and evaluate rapid dissolving sublingual tablets of Promethazine HCl (10mg) for better treatment of vomiting especially for motion sickness. In general Promethazine HCl having only 25% oral bioavailability because of its high first pass metabolism rate. Thus, formulated sublingual tablets of Promethazine HCl prevents or avoids first pass metabolism and their absorption directly takes place into the sublingual mucosa which results in better oral bioavailability compared to conventional Promethazine HCl tablets. Nine different formulations of Promethazine HCl with different concentrations of 3 superdisintegrants namely Crospovidone, L-HPC, and Kyron T-314 were formulated. Precompression and post compression parameters were evaluated for all the nine formulations. The formulation PF3 with Crospovidone (7.5%) was found to be the most effective in terms of in-vitro disintegration and in-vitro dissolution profiles. Formulation PF5 was found to have % drug content (95-105%). CONCLUSION The Promethazine HCl tablets of strength 100 mg with different strengths of superdisintegrants were formulated to target the symptoms of motion sickness. Due to rapid disintegration and dissolution quick onset of

6 64 action was achieved. ACKNOWLEDGEMENTS This work was carried out in the laboratories of MVP Samaj s college of pharmacy, Nashik under the guidance of Dr. D. V. Derle in the department of Pharmaceutics. I am thankful to all related authorities and personnel s. REFERENCES Al Ghananeem AM, Malkawi AH, Crooks PA. Effect of ph on Sublingual Absorption of Oxycodone Hydrochloride. AAPS PharmSciTech. 2006; 7(1): Article 23. Allen LV. Rapid dissolve technology: an interview. Int J Pharm Technol. 2003; 7: Boer D et al. Drug absorption by sublingual and rectal routes. British J Anaesthesia. 1984; 56: British Pharmacopoeial Commission. British Pharmacopoeia. London: Stationery Office Books. 2009; Ghosh TK, Chatterjee DJ, Pfister WR. Quick dissolving oral dosage forms: Scientific and regulatory considerations from a clinical pharmacology and biopharmaceutical perspective. Drug Delivery to the Oral Cavity Molecules to Market. CRC Press, New York, 2005: Katz M, Barr M. A study of sublingual absorption I. Several factors influencing the rate of adsorption.j Am Pharm Assoc. Baltim. 1955; 44(7): Kurosaki Y, Takatori T, Nishimura H, Nakayama T, Kimura T. Regional variation in oral mucosal drug absorption permeability and degree of keratinization in hamster oral cavity. Pharm Res. 1991; 8: Richman MD, Fox D, Shangraw RF. Preparation and stability of glyceryl trinitrate sublingual tablets prepared by direct compression. J Pharm Sci. 1965; 54(3): The Drug Bank [Database on the Internet]. Supported by Wishart D. Department of computer science and biological sciences, University of Alberta The Indian Pharmacopoeia Commission, Government of India, Ministry of Health & Family Welfare, Ghaziabad. 2007; 3: Walton RP. Absorption of drugs through the oral mucosa.fat water solubility coefficient of alkaloids. Proc Soc Exp Bio Med. 1935; 32: 1488.

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