Generic placeholder image

Current Pharmaceutical Design

Editor-in-Chief

ISSN (Print): 1381-6128
ISSN (Online): 1873-4286

Review Article

Human Health Effects of Lactose Consumption as a Food and Drug Ingredient

Author(s): Rafael G. Seoane, Verónica Garcia-Recio, Manuel Garrosa, María Á. Rojo, Pilar Jiménez, Tomás Girbés, Manuel Cordoba-Diaz * and Damián Cordoba-Diaz*

Volume 26, Issue 16, 2020

Page: [1778 - 1789] Pages: 12

DOI: 10.2174/1381612826666200212114843

Price: $65

Abstract

Lactose is a reducing sugar consisting of galactose and glucose, linked by a β (1→4) glycosidic bond, considered as an antioxidant due to its α-hydroxycarbonyl group. Lactose is widely ingested through the milk and other unfermented dairy products and is considered to be one of the primary foods. On the other hand, lactose is also considered as one of the most widely used excipients for the development of pharmaceutical formulations. In this sense, lactose has been related to numerous drug-excipient or drug-food pharmacokinetic interactions.

Intolerance, maldigestion and malabsorption of carbohydrates are common disorders in clinical practice, with lactose-intolerance being the most frequently diagnosed, afflicting 10% of the world’s population. Four clinical subtypes of lactose intolerance may be distinguished, namely lactase deficiency in premature infants, congenital lactase deficiency, adult-type hypolactasia and secondary lactase intolerance. An overview of the main uses of lactose in human nutrition and in the pharmaceutical industry and the problems derived from this circumstance are described in this review.

Keywords: Lactose, antioxidant, excipient, food, interaction, intolerance.

[1]
Carocho M, Morales P, Ferreira ICFR. Sweeteners as food additives in the XXI century: A review of what is known, and what is to come. Food Chem Toxicol 2017; 107(Pt A): 302-17.
[http://dx.doi.org/10.1016/j.fct.2017.06.046] [PMID: 28689062]
[2]
Considine JA, Frankish E. A Complete guide to quality in small-scale wine making. Academic Press 2014.
[3]
Wehmeier KR, Mooradian AD. Autoxidative and antioxidative potential of simple carbohydrates. Free Radic Biol Med 1994; 17(1): 83-6.
[http://dx.doi.org/10.1016/0891-5849(94)90010-8] [PMID: 7959169]
[4]
Romero del Castillo Shelly R, Mestres Lagarriga J. Productos lacteos. Barcelona: Tecnologia, Ediciones Universidad Politecnica de Cataluna 2004; pp. 21-33.
[5]
Ugidos-Rodríguez S, Matallana-González MC, Sánchez-Mata MC. Lactose malabsorption and intolerance: a review. Food Funct 2018; 9(8): 4056-68.
[http://dx.doi.org/10.1039/C8FO00555A] [PMID: 29999504]
[6]
Zadow JG. Lactose: properties and uses. J Dairy Sci 1984; 67(11): 2654-79.
[http://dx.doi.org/10.3168/jds.S0022-0302(84)81625-2]
[7]
Thorning TK, Raben A, Tholstrup T, Soedamah-Muthu SS, Givens I, Astrup A. Milk and dairy products: good or bad for human health? An assessment of the totality of scientific evidence. Food Nutr Res 2016; 60: 32527.
[http://dx.doi.org/10.3402/fnr.v60.32527] [PMID: 27882862]
[8]
Ohlsson JA, Johansson M, Hansson H, et al. Lactose, glucose and galactose content in milk, fermented milk and lactose-free milk products. Int Dairy J 2017; 73: 151-4.
[http://dx.doi.org/10.1016/j.idairyj.2017.06.004]
[9]
Suri S, Kumar V, Prasad R, et al. Considerations for development of lactose-free food. J Nutr Intermed Metab 2019; 15: 27-34.
[http://dx.doi.org/10.1016/j.jnim.2018.11.003]
[10]
Regulation (EU) No 1129/2011 of the European Parliament and of the Council by establishing a Union list of food additives. Off J Eur Union 2011.L295/1-L295/177. Available from:. https://eur-lex.europa.eu/homepage.html
[11]
CFR - Code of Federal Regulations Title 21. US Department of Health and Human Services. US Food and Drug Administration 2019.Available from:. https://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/ cfcfr/cfrsearch.cfm
[12]
WHO, Report of the twenty-third session of the joint FAO/ WHO Codex Alimentarius Commission. Rome, 28 June - 3 July. Geneva, SwitzerlandWorld Health Organization
[13]
La Orden Izquierdo E, Carabano Aguado I, Pelayo Garcia FJ. Situacion actual de la intolerancia a la lactosa en la infancia Rev Pediatr. Aten Primaria 2011; 13(50): 2-4.
[14]
Yilmaz Y, Toledo R. Antioxidant activity of water-soluble Maillard reaction products. Food Chem 2005; 93(2): 273-8.
[http://dx.doi.org/10.1016/j.foodchem.2004.09.043]
[15]
Monti SM, Ritieni A, Graziani G, et al. LC/MS analysis and antioxidative efficiency of Maillard reaction products from a lactose-lysine model system. J Agric Food Chem 1999; 47(4): 1506-13.
[http://dx.doi.org/10.1021/jf980899s] [PMID: 10564007]
[16]
Spillane WJ. Molecular structure and sweet taste Advances in Sweeteners. 2nd ed. Glasgow: Blackie Academic and Professional 2012; pp. 6-25.
[17]
Ensor M, Williams J, Smith R, Banfield A, Lodder RA. Effects of three low doses of D-tagatose on glycemic control over six months in subjects with mild type 2 diabetes mellitus under control with diet and exercises. J Endocrinol Diabetes Obes 2014; 2(4): 1057-84.
[PMID: 25580449]
[18]
Jayamuthunagai J, Gautam P, Srisowmeya G, Chakravarthy M. Biocatalytic production of D-tagatose: A potential rare sugar with versatile applications. Crit Rev Food Sci Nutr 2017; 57(16): 3430-7.
[http://dx.doi.org/10.1080/10408398.2015.1126550] [PMID: 26745466]
[19]
Tandel KR. Sugar substitutes: Health controversy over perceived benefits. J Pharmacol Pharmacother 2011; 2(4): 236-43.
[http://dx.doi.org/10.4103/0976-500X.85936] [PMID: 22025850]
[20]
Silanikove N, Shapiro F. Combined assays for lactose and galactose by enzymatic reactions. Dietary sugars: chemistry, analysis, function and effects, food and nutritional components in focus. cambridge: the royal society of chemistry 2012; 3: 397-406.
[21]
Lomer MC, Parkes GC, Sanderson JD. Review article: lactose intolerance in clinical practice--myths and realities. Aliment Pharmacol Ther 2008; 27(2): 93-103.
[http://dx.doi.org/10.1111/j.1365-2036.2007.03557.x] [PMID: 17956597]
[22]
Amiri M, Diekmann L, von Köckritz-Blickwede M, Naim HY. The diverse forms of lactose intolerance and the putative linkage to several cancers. Nutrients 2015; 7(9): 7209-30.
[http://dx.doi.org/10.3390/nu7095332] [PMID: 26343715]
[23]
Deng Y, Misselwitz B, Dai N, Fox M. Lactose intolerance in adults: Biological mechanism and dietary management. Nutrients 2015; 7(9): 8020-35.
[http://dx.doi.org/10.3390/nu7095380] [PMID: 26393648]
[24]
Brüssow H. Nutrition, population growth and disease: a short history of lactose. Environ Microbiol 2013; 15(8): 2154-61.
[http://dx.doi.org/10.1111/1462-2920.12117] [PMID: 23574334]
[25]
Garcia Delgado Y, Alberiche Ruano MP, Sanchez Hernandez RM, Gonzalez Medina RA. Soporte nutricional en patologias con alteracion en el procesamiento de los hidratos de carbono Dieta controlada en fructosa Dieta controlada en sacarosa Dieta restringida en galactosaDietoterapia, Nutricion Clinica y Metabolismo. 3rd ed. Aula medica 2017; pp. 237-40.
[26]
Wanes D, Husein DM, Naim HY. Congenital lactase deficiency: Mutations, functional and biochemical implications, and future perspectives. Nutrients 2019; 11(2) E461
[http://dx.doi.org/10.3390/nu11020461] [PMID: 30813293]
[27]
Scientific opinion on lactose thresholds in lactose intolerance and galactosaemia. EFSA J 2010; 8: 1777.Available at:. https://www.efsa.europa.eu/ en/efsajournal/pub/1777
[http://dx.doi.org/10.2903/j.efsa.2010.1777]
[28]
Niewinski MM. Advances in celiac disease and gluten-free diet. J Am Diet Assoc 2008; 108(4): 661-72.
[http://dx.doi.org/10.1016/j.jada.2008.01.011] [PMID: 18375224]
[29]
Shaukat A, Levitt MD, Taylor BC, et al. Systematic review: effective management strategies for lactose intolerance. Ann Intern Med 2010; 152(12): 797-803.
[http://dx.doi.org/10.7326/0003-4819-152-12-201006150-00241] [PMID: 20404262]
[30]
Furnari M, Bonfanti D, Parodi A, et al. A comparison between lactose breath test and quick test on duodenal biopsies for diagnosing lactase deficiency in patients with self-reported lactose intolerance. J Clin Gastroenterol 2013; 47(2): 148-52.
[http://dx.doi.org/10.1097/MCG.0b013e31824e9132] [PMID: 22495813]
[31]
Fergusson A, Griffin GE. Nutrition and the immune system Human nutrition and dietetics. 10th ed. Churchill Livingston 2000; pp. 761-3.
[32]
Pohl D, Savarino E, Hersberger M, et al. Excellent agreement between genetic and hydrogen breath tests for lactase deficiency and the role of extended symptom assessment. Br J Nutr 2010; 104(6): 900-7.
[http://dx.doi.org/10.1017/S0007114510001297] [PMID: 20398434]
[33]
Szilagyi A, Ishayek N. Lactose intolerance, dairy avoidance, and treatment options. Nutrients 2018; 10(12): pii. E 1994.
[http://dx.doi.org/10.3390/nu10121994] [PMID: 30558337]
[34]
Regulation (EU) No 609/2013 of the European Parliament and of the Council on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control. Off J Eur Union 2013.L181/35-56. Available from:. https://eur-lex.europa.eu/homepage.html
[35]
Scientific and technical guidance on foods for special medical purposes in the context of Article 3 of Regulation (EU) No 609/2013. EFSA J 2015; 13(11): 4300.Available from:. https://www.efsa.europa.eu/en/ efsajournal/pub/4300
[36]
Gil Gregorio P. Intolerancia a la lactosa. Una patología emergente.Sociedad Española de Geriatría y Gerontología 2013; 8-16.Available from:. https://www.segg.es/media/descargas/ Gu%C3%ADa%20de%20intolerancia%20a%20la%20lactosa%20-%20una%20patolog%C3%ADa%20emergente%20%20mayo%202013.pdf
[37]
Usme P, Jaramillo DM, Alvarez F. Microencapsulacion de la lactasa como estrategia para mejorar la estabilidad y la aplicación en la industria de los alimentos: Corporacion Universitaria Lasallista, Facultad de Ingeniería. especializacion en alimentacion y nutricion, Caldas, Antioquia 2013; 21-3.Available from:. http://hdl.handle.net/10567/973
[38]
Silanikove N, Leitner G, Merin U. The interrelationships between lactose intolerance and the modern dairy industry: global perspectives in evolutional and historical backgrounds. Nutrients 2015; 7(9): 7312-31.
[http://dx.doi.org/10.3390/nu7095340] [PMID: 26404364]
[39]
Tomar BS. Lactose intolerance and other disaccharidase deficiency. Indian J Pediatr 2014; 81(9): 876-80.
[http://dx.doi.org/10.1007/s12098-014-1346-2] [PMID: 24596060]
[40]
Rowe RC, Sheskey PJ, Quinn ME, Eds. Handbook of pharmaceutical excipients. 6th ed. London: Pharmaceutical Press 2009.
[41]
CIMA-Medicine Online Information Center. AEMPS (Spanish Agency for Drugs and Medical Devices). Available from: https://www.aemps.gob.es
[42]
Altamimi MJ, Wolff K, Nokhodchi A, Martin GP, Royall PG. Variability in the α and β anomer content of commercially available lactose. Int J Pharm 2019; 555: 237-49.
[http://dx.doi.org/10.1016/j.ijpharm.2018.10.061] [PMID: 30395957]
[43]
Batuyios NH. Anhydrous lactose in direct tablet compression. J Pharm Sci 1966; 55(7): 727-30.
[http://dx.doi.org/10.1002/jps.2600550712] [PMID: 5967752]
[44]
Whiteman M, Yarwood RJ. The evaluation of six lactose-based materials as direct compression tablet excipients. Drug Dev Ind Pharm 1988; 14(8): 1023-40.
[http://dx.doi.org/10.3109/03639048809151918]
[45]
Ilić I, Kása P Jr, Dreu R, Pintye-Hódi K, Srcic S. The compressibility and compactibility of different types of lactose. Drug Dev Ind Pharm 2009; 35(10): 1271-80.
[http://dx.doi.org/10.1080/03639040902932945] [PMID: 19466896]
[46]
Sebhatu T, Alderborn G. Relationships between the effective interparticulate contact area and the tensile strength of tablets of amorphous and crystalline lactose of varying particle size. Eur J Pharm Sci 1999; 8(4): 235-42.
[http://dx.doi.org/10.1016/S0928-0987(99)00025-1] [PMID: 10425373]
[47]
Du J, Hoag SW. The influence of excipients on the stability of the moisture sensitive drugs aspirin and niacinamide: comparison of tablets containing lactose monohydrate with tablets containing anhydrous lactose. Pharm Dev Technol 2001; 6(2): 159-66.
[http://dx.doi.org/10.1081/PDT-100000742] [PMID: 11416989]
[48]
Bolhuis GK, Zuurman K. Tableting properties of experimental and commercially available lactose granulations for direct compression. Drug Dev Ind Pharm 1995; 21(18): 2057-71.
[http://dx.doi.org/10.3109/03639049509065890]
[49]
Badawy SI. Material physical modifications induced by wet granulationhandbook of pharmaceutical wet granulation handbook of pharmaceutical wet granulation. Academic Press 2019; pp. 173-202.
[http://dx.doi.org/10.1016/B978-0-12-810460-6.00014-2]
[50]
Fara DA. A comparison of industrial lactose obtained by roller compaction with spray dried lactose and α-lactose monohydrate using compression analysis techniques. J Excip Food Chem 2019; 10(2): 41-54.
[51]
Paul S, Tajarobi P, Boissier C, Sun CC. Tableting performance of various mannitol and lactose grades assessed by compaction simulation and chemometrical analysis. Int J Pharm 2019; 566: 24-31.
[http://dx.doi.org/10.1016/j.ijpharm.2019.05.030] [PMID: 31095984]
[52]
Shah KR, Hussain MA, Hubert M, Farag Badawy SI. Form conversion of anhydrous lactose during wet granulation and its effect on compactibility. Int J Pharm 2008; 357(1-2): 228-34.
[http://dx.doi.org/10.1016/j.ijpharm.2008.02.008] [PMID: 18374527]
[53]
Grote S, Kleinebudde P. A comparative study of the influence of alpha-lactose monohydrate particle morphology on granule and tablet properties after roll compaction/dry granulation. Pharm Dev Technol 2019; 24(3): 314-22.
[http://dx.doi.org/10.1080/10837450.2018.1476977] [PMID: 29757067]
[54]
Abu Fara D, Rashid I, Alkhamis K, Al-Omari M, Chowdhry BZ, Badwan A. Modification of α-lactose monohydrate as a direct compression excipient using roller compaction. Drug Dev Ind Pharm 2018; 44(12): 2038-47.
[http://dx.doi.org/10.1080/03639045.2018.1508224] [PMID: 30095020]
[55]
Ito A, Kleinebudde P. Influence of granulation temperature on particle size distribution of granules in twin-screw granulation (TSG). Pharm Develop Tech 2019; pp. 1-9.
[56]
Thulluru A, Madhavi C, Nandini K, Sirisham S, Spandana D. Co-processed excipients: new era in pharmaceuticals. Asian J Res Pharm Sci 2019; 9(1): 1-5.
[http://dx.doi.org/10.5958/2231-5659.2019.00001.8]
[57]
US20050106237A. Wuthrich P, Rolland H, Julien M. Inventors; Orodispersable pharmaceutical composition comprising perindopril. United States patent. Available from: https://patents.google.com/ patent/US20050106237A1/en
[58]
Lawal MV. Modified starches as direct compression excipients-effect of physical and chemical modifications on tablet properties: A review. Starke 2019; 71(1-2) 1800040
[http://dx.doi.org/10.1002/star.201800040]
[59]
Estrada Flores L, Lopez Arellano R, Díaz Esquivel JJ. Study of load capacity of Avicel PH-200 and Cellactose, two direct compression excipients, using experimental design. Drug Dev Ind Pharm 2000; 26(4): 465-9.
[http://dx.doi.org/10.1081/DDC-100101256] [PMID: 10769791]
[60]
Belda PM. The tableting behavior of cellactose compared with mixtures of cellulose with lactose. Eur J Pharm Biopharm 1996; 42: 325-30.
[61]
Michoel A, Rombaut P, Verhoye A. Comparative evaluation of co-processed lactose and microcrystalline cellulose with their physical mixtures in the formulation of folic acid tablets. Pharm Dev Technol 2002; 7(1): 79-87.
[http://dx.doi.org/10.1081/PDT-120002233] [PMID: 11852699]
[62]
Muzikova J, Zvolankova J. A study of the properties of tablets from coprocessed dry binders composed of alpha-lactose monohydrate and different types of cellulose.Ceska a Slovenska farmacie: casopis Ceske farmaceuticke spolecnosti a Slovenske farmaceuticke spolecnosti 2007; 56(6): 269-75.
[63]
Kinnunen H, Hebbink G, Peters H, Shur J, Price R. An investigation into the effect of fine lactose particles on the fluidization behaviour and aerosolization performance of carrier-based dry powder inhaler formulations. AAPS PharmSciTech 2014; 15(4): 898-909.
[http://dx.doi.org/10.1208/s12249-014-0119-6] [PMID: 24756910]
[64]
Chow AH, Tong HH, Chattopadhyay P, Shekunov BY. Particle engineering for pulmonary drug delivery. Pharm Res 2007; 24(3): 411-37.
[http://dx.doi.org/10.1007/s11095-006-9174-3] [PMID: 17245651]
[65]
Hebbink GA, Dickhoff BH. Application of lactose in the pharmaceutical industry.Lactose evolutionary role, health effects, and applications. academic press 2019; 175-229.
[http://dx.doi.org/10.1016/B978-0-12-811720-0.00005-2 ]
[66]
Vanderbist F, Wery B, Moyano-Pavon I, Moës AJ. Optimization of a dry powder inhaler formulation of nacystelyn, a new mucoactive agent. J Pharm Pharmacol 1999; 51(11): 1229-34.
[http://dx.doi.org/10.1211/0022357991776958] [PMID: 10632079]
[67]
Larhrib H, Zeng XM, Martin GP, Marriott C, Pritchard J. The use of different grades of lactose as a carrier for aerosolised salbutamol sulphate. Int J Pharm 1999; 191(1): 1-14.
[http://dx.doi.org/10.1016/S0378-5173(99)00164-7] [PMID: 10556735]
[68]
Pitchayajittipong C, Price R, Shur J, Kaerger JS, Edge S. Characterisation and functionality of inhalation anhydrous lactose. Int J Pharm 2010; 390(2): 134-41.
[http://dx.doi.org/10.1016/j.ijpharm.2010.01.028] [PMID: 20100552]
[69]
Styliari ID, Mobli A, Murnane D. Physicochemical characterisation of inhalation grade lactose after the removal of intrinsic fines.Proceedings of the Drug Delivery to the Lungs (DDL2018) 2018.Dec; 12-4. Available from:. http://hdl.handle.net/2299/21247
[70]
Shalash AO, Khalafallah NM, Molokhia AM, Elsayed MMA. The relationship between the permeability and the performance of carrier-based dry powder inhalation mixtures: new insights and practical guidance. AAPS PharmSciTech 2018; 19(2): 912-22.
[http://dx.doi.org/10.1208/s12249-017-0898-7] [PMID: 29063377]
[71]
US20180000946A1. Lee SW, Kim GH, Seo MH. Inventors; Samyang Biopharmaceuticals Corp., assignee. Polymer nanoparticle freeze-dried product, and preparation method therefor. Available from: https://patents.google.com/patent/US20180000946A1/en
[72]
US8277845B2. Jacobson SM. inventor; Biogen Chesapeake LLC., assignee. Formulations and methods for lyophilization and lyophilates provided thereby. United States patent. Available from: https://patents.google.com/patent/US8277845B2/en
[73]
Baheti A, Kumar L, Bansal AK. Excipients used in lyophilization of small molecules. J Excip Food Chem 2016; 1(1): 1135-9.
[74]
Q6A.4 ICH guideline. Specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances. International conference on harmonization. 1999. Available from:. http://www.ich.org/
[75]
Sanchez E, Jung H, Yepez L, Hernandez-Abad V. Relevancia del polimorfismo en el area farmaceutica. Rev Mex Cienc Farm 2007; 38(2): 57-76.
[76]
Strachan CJ, Rades T, Gordon KC, Rantanen J. Raman spectroscopy for quantitative analysis of pharmaceutical solids. J Pharm Pharmacol 2007; 59(2): 179-92.
[http://dx.doi.org/10.1211/jpp.59.2.0005] [PMID: 17270072]
[77]
Singhal D, Curatolo W. Drug polymorphism and dosage form design: a practical perspective. Adv Drug Deliv Rev 2004; 56(3): 335-47.
[http://dx.doi.org/10.1016/j.addr.2003.10.008] [PMID: 14962585]
[78]
Advanced Manufacturing: a Snapshot of Priority Technology Areas Across the Federal Government 2006.Available from:. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
[79]
Quality Considerations for Continuous Manufacturing Guidance for Industry. Silver Spring, USA: Draft Guidance 2019.
[80]
Q8-R2 ICH guideline. Pharmaceutical Development. International Conference on Harmonization 2009.Available from . http://www.ich.org/
[81]
Q9 ICH guideline. Quality Risk Management. International Conference on Harmonization 2005.Available from. http://www.ich.org/
[82]
Q10 ICH guideline. 8. Pharmaceutical Quality System. International Conference on Harmonization 2008.Available from:. http://www.ich.org/
[83]
Rocca KE, Weatherley S, Sheskey PJ, Thompson MR. Influence of filler selection on twin screw foam granulation. Drug Dev Ind Pharm 2015; 41(1): 35-42.
[http://dx.doi.org/10.3109/03639045.2013.845839] [PMID: 24111830]
[84]
Vercruysse J, Burggraeve A, Fonteyne M, et al. Impact of screw configuration on the particle size distribution of granules produced by twin screw granulation. Int J Pharm 2015; 479(1): 171-80.
[http://dx.doi.org/10.1016/j.ijpharm.2014.12.071] [PMID: 25562758]
[85]
Djuric D, Kleinebudde P. Continuous granulation with a twin-screw extruder: impact of material throughput. Pharm Dev Technol 2010; 15(5): 518-25.
[http://dx.doi.org/10.3109/10837450903397578] [PMID: 19921959]
[86]
Fonteyne M, Vercruysse J, Díaz DC, et al. Real-time assessment of critical quality attributes of a continuous granulation process. Pharm Dev Technol 2013; 18(1): 85-97.
[http://dx.doi.org/10.3109/10837450.2011.627869] [PMID: 22023327]
[87]
Vanhoorne V, Bekaert B, Peeters E, De Beer T, Remon JP, Vervaet C. Improved tabletability after a polymorphic transition of delta-mannitol during twin screw granulation. Int J Pharm 2016; 506(1-2): 13-24.
[http://dx.doi.org/10.1016/j.ijpharm.2016.04.025] [PMID: 27094358]
[88]
Van Den Abeele J, Rubbens J, Brouwers J, Augustijns P. The dynamic gastric environment and its impact on drug and formulation behaviour. Eur J Pharm Sci 2017; 96: 207-31.
[http://dx.doi.org/10.1016/j.ejps.2016.08.060] [PMID: 27597144]
[89]
Hall JE. SSecretory Functions of the Alimentary Tract. In: IN, Guyton and Hall textbook of medical physiology e-Book. Elsevier Health Sciences. In: 2015; pp. 817-31.
[90]
Hall J E. Digestion and absorption in the gastrointestinal tract. IN, Guyton and Hall textbook of medical physiology e-Book 2015; 833-41.
[91]
Rodriguez A, Zuleta J. De la fisiologia del vaciamiento gastrico al entendimiento de la gastroparesia. Rev Col Gastroenterol 2010; 25(2)
[92]
Kortejärvi H, Urtti A, Yliperttula M. Pharmacokinetic simulation of biowaiver criteria: the effects of gastric emptying, dissolution, absorption and elimination rates. Eur J Pharm Sci 2007; 30(2): 155-66.
[http://dx.doi.org/10.1016/j.ejps.2006.10.011] [PMID: 17187967]
[93]
Darwich AS, Margolskee A, Pepin X, et al. IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 3: Identifying gaps in system parameters by analysing In Silico performance across different compound classes. Eur J Pharm Sci 2017; 96: 626-42.
[http://dx.doi.org/10.1016/j.ejps.2016.09.037] [PMID: 27693299]
[94]
Wilson CG, O’Mahony B, Connolly SM, et al. Do gastrointestinal transit parameters influence the pharmacokinetics of gefitinib? Int J Pharm 2009; 376(1-2): 7-12.
[http://dx.doi.org/10.1016/j.ijpharm.2009.04.008] [PMID: 19497691]
[95]
Whitman Z, O’Neil DHR. Gastric disorders: modifications of gastric content, antacids and drugs influencing gastric secretions and motility. Anesthesia Intens Care Med 2018; 19: 1.
[http://dx.doi.org/10.1016/j.mpaic.2017.10.011]
[96]
Barcia Hernandez E, Negro Alvarez S. Fundamentos de las interacciones farmacocinéticos (I). An Real Acad Farm 2002; 68(2)
[97]
Atkinson RM, Bedford C, Child KJ, Tomich EG. Effect of particle size on blood griseofulvin-levels in man. Nature 1962; 193(4815): 588-9.
[http://dx.doi.org/10.1038/193588a0] [PMID: 13863116]
[98]
Atkinson RM, Bedford C, Child KJ, Tomich EG. The effect of griseofulvin particle size on blood levels in man. Antibiot Chemother (Northfield) 1962; 12(4): 232-8.
[http://dx.doi.org/10.1038/193588a0] [PMID: 13863118]
[99]
Singh P, Chadha R. A new polymorph of ciprofloxacin saccharinate: Structural characterization and pharmaceutical profile. J Pharm Biomed Anal 2017; 146: 7-14.
[http://dx.doi.org/10.1016/j.jpba.2017.07.036] [PMID: 28841428]
[100]
Fenner KS, Troutman MD, Kempshall S, et al. Drug-drug interactions mediated through P-glycoprotein: clinical relevance and in vitro-in vivo correlation using digoxin as a probe drug. Clin Pharmacol Ther 2009; 85(2): 173-81.
[http://dx.doi.org/10.1038/clpt.2008.195] [PMID: 18987624]
[101]
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers. Off J Eur Union 2011.L304/18-63. Available from:. https://eur-lex.europa.eu/homepage.html
[102]
Becker C, Dressman JB, Amidon GL, et al. Biowaiver monographs for immediate release solid oral dosage forms: isoniazid. J Pharm Sci 2007; 96(3): 522-31.
[http://dx.doi.org/10.1002/jps.20765] [PMID: 17117431]
[103]
Fassio F, Facioni MS, Guagnini F. Lactose maldigestion, malabsorption, and intolerance: A comprehensive review with a focus on current management and future perspectives. Nutrients 2018; 10(11): 1599.
[http://dx.doi.org/10.3390/nu10111599] [PMID: 30388735]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy