ee SSwretl Kure. Code : 091801 B.Pharm 8th Semester Exam., 2021 PHARMACEUTICS—IX ( Dosage Form Design ) Time : 3 hours Full Marks : 70 Instructions : () The marks are indicated in the right-hand margin. (i) There are NINE questions in this paper. (i) Attempt FIVE questions in all. (iv) Question No. 1 is compulsory. Nec oa as any seven of the following as directed : 2x7=14 Define the following terms : (a) Degree of flocculation (b) Sedimentation volume of suspension or Dipole moment ya Dissociation constant Sef Organoleptic properties Stability of Bioavailability AK-21/646 ( Turn. Over )(2) Write True or False : fp The diameter of disperse phase (suspension) may range from 0-5 jim- 100 um. Sf System in which particle size is below the range 0S wm-100 jum is called colloidal. @ Wetting-agent has HLB value 8-10. oe about the formulation and evaluation Of tablets. 14 3. Explain about the evaluation of suspension. 14 4. Write about the in-vitro method of evaluation and statistical treatment. 14 J Piscuss in detail about in-vitro dissolution studies of tablets. 14 fow do the physical properties of drug molecules influence the formulation and stability? 14 7. Write in detail about the dielectric constant and racemization. 14 AK-21/646 ( Continued ) (3) Write short notes on the following: 7*2-14 sar” Physical properties of drugs Dp Quality assurance 7 short notes on the following: 7*2=14 (a) Quality audit (6) Bioequivalence studies AK-21—200/646 Code : 091801B.Pharm 8th Semester Exam., 2020 PHARMACEUTICS—IX (Dosage Form Design) Time : 3-hours Full Marks: 70 Instructions : (i) The marks are indicated in the right-hand margin. (ii) There are NINE question in this paper. (iti) Attempt FIVE questions in all. (iv) Question No. 1 is compulsory. 1. Answer the following questions (any seven): 2x7=14 (a) What is accelerated stability testing? What do you mean by dose dumping? (c) What is concurrent validation? (ad) What is biowaiver? fr What is’ process: validation? “sy What. is pKa? How it effect. the \bioavailabity of drugs? : e(g) Differentiate between angle of repose and contact angle. (h) Mention the limit for disintegration time of hard gelatin capsule. =a = Give four_examples of drugs that require consideration of particle size. What are antioxidants? Give two examples. eX 2. (a) Discuss BCS classification of drugs. (b) What are the physical factors affecting formulation aspects of a drug ae ee 3/ (a plain. federal considerations on stability testing of drugs. Pes validation of raw sanherial) 4. Discuss different bioavailability enhancement techniques. éscribe in vitro dissolution studies for solid dosage form methods..¢v/5. (a) Explain validation for the production of DS suspension I.P. 7 (b) Discuss about various control parameters during. production of tablets. 7 - 6. Highlight design and _ evaluation of sustained released formulation. Ts: 7. Discuss the ICH guidelines for stability testing of the following : 14 (a) Solid oral products intended for storage at room temperature (b) Products intended to be stored in refrigerator & Give the importance of validation and ~ CGMP in production of pharmaceutical . products. 7 (b) Explain the utility of prodrugs in enhancing the stability and preformance of drugs. : 7(4) give note on (any two)’: 7x2=14 we Quality assurance and quality control ¥% (b) Bioequivalence © studies ue Peeformatation studiesaE Semester Exam,, 2019 ' sPHARMACBUTICS “IX” Time : 3 oath aawallal Full, Marks : 70 Instructions : 7 9 ottastonngy = Oh (i) The marks are indicated i in ‘the a ri -hand margin. (ii) There are NINE questions in this paper. (iii) Attempt FIVE questions in all ab fp oltW 8 . (iv) Question No. 1 is compulsory. *3 110 1. Answer the, followipe: as directed ot neva: 5 OxT= 14 Give full forms of the following ‘ ‘abbreviations ‘:'*' / fa! TGA and psc ee (), XRD, and. SEM), j:n.: polints: unw .2 Jd OECD and GMP noivicacal 2 (a) USP aad NF = aie! “eat i} mo mofo fone State rel hin ‘the following statements are True or False : es (e) 5%+15% compressibility is*indicator’ of excellent flow ability. (9 ’' The’ solubility of ‘acidic’ or’ basic. drug” depends on its pK,.(2) (g) HPLC can be used for both quantitative and qualitative evaluation of a drug. (h) The power of a test is its ability to detect a difference if it truly exists. Define the following : () | Organoleptic properties G) Bioavailability Write a detailed note on preparation and evaluation of suspension. 14 How do the chemical properties of a molecule influence the formulation and stability? 14 Discuss the statistical methods used in formulation development. 14 Write a detailed note on controlled released formulation. 14 Write short notes on the following : 7Tx2=14 (a) GMP (b) ..Physical properties of a drug Explain in detail, the in vitro dissolution studies. 14(3) *3) Describe process validation for tablet. 14 Write short notes on the following : 7x2=14 (a) Quality audit (b) Stability testing protocol r r kkkB.Pharm. 8th Semester Exam., 2017 Pharmaceutics-IX ~ Time : 3 hours ~ : 5 Full Marks : 70 Instructions : ; ()\ The marks are indicated in the right-hand margin. (ii) _ There are Nine questions in this paper. (iii) Attempt Five questions in all. (iv) Questions No. I is compulsory. 1. Answer any seven of the following: 2x7T=14 _fay Define validation. 6). Define racemization. (c) Define controlled release formulaions. (d)-Define reduction. \ fey Define Shelf life. Be) Define wetting. ¢ \@F Define quality assurance. a) Define bioequivalence. ZYQ- g A) Define disintegration. «{S4* Aj) Define therapeutic index. 223° aR Pp UWineu fa adi pa «S§ q &* 24° Write in brief salient features of Good Manufacturing ’. Practices. 14 eee Discuss different type of controlled release formulation and brief on in vitro dissolution studies. “4 -4, Write short notes on following: “W¥T=14 ey Accelerated stability testing (b) In vitro-In vivo correlation 5. Discuss the following. properties of the drug, which influence formulation and stability of formulations: 44+5+5=14 (a) Racemization (b) Polymerization (c)-Reduction “Describe process validation methods for pharmaceutical _ operations involved in production of pharmaceutical products. 14, IC “What do you mean by quality assurance ? Write briefly the salient features to ensure quality assurance. 14 8. Describe following properties of drug used in preformulation studies: 4+5+5=14 (a) Dielectric constant (by Solubility (c) Stability9° Describe bioavailability and discuss two methods of measurement of bioavailability given below: 2+6+6=14 (a) Plasma level time studies © (b) Uriniary excretion studies . EKB.Pharm Sth Semester Exacm., 2015 PHARMACEUTICS—i1X Time : 3 hours : Pull Marks . 7& houstructions : ( The marks are indicated in the right-hand margin. a Si) There are NINE questions ix. this paper. (ili) Attempt FIVE questions i all. (iv) Question No. I is compulsory. 1. Answer any seven of the following : (a) Define reduction..,.- (b} Define dissolution: _ {co} Define validation, .(@) Define stability. fe Define polymor rucemizat ‘ig! pate netting t na protoce?(2) 2 How do the following affect 1 the foowashiticaeet ‘dosage forms? /Reduction {a} Discuss different types of controlied release for tion and byef on in vitro dissolution studies. Give a brief. write-up on the imporience e \? ~ Sabkiation techniques in pharii operations, Quote one example. \@ cust the Pblications 0 phend © Se nh vptlos Oleted to ek ato critical 14 14 Give examples. —_ U5.(34 jeptic property RATES KK Bun gPor (RRA)